Supporting Looked After Children and Care Leavers In Decreasing Drugs, and Alcohol) that aimed to adapt two evidence-based psychosocial interventions, Motivational Enhancement Therapy and Social Behaviour and Network Therapy, which will aim to reduce substance misuse by looked after children.Looked after children and care leavers have an increased risk of drug and alcohol use compared to their non-LAC peers. Despite high prevalence rates within this population, looked after children are reported to show low levels of engagement in services resulting in unmet needs emerging from substance use. This paper reports on the initial formative phase of a pilot feasibility randomised controlled trial; SOLID . Findings were used to adapt and refine the interventions prior to the trial.Overall findings suggested that whilst original components of both interventions were feasible to deliver and acceptable, specific process areas were highlighted including: increased emphasis upon therapeutic relationships, the benefits of using creative non-traditional methods of engagement and identification of treatment goals wider than those narrowly focused on substance misuse.This paper provides an example of methods used to collect multiple perspectives to refine and co-develop interventions to reduce drug and alcohol use in the specific population of looked after children.ISRCTN80786829 (first registered 06.06.2016- prospectively registered). One in every 156 children in the UK is looked after by the state . A natioLAC have often experienced family breakdown, neglect and abuse prior to entering care and have had little or no control in many aspects of their lives including their living arrangements or ‘placements’. This level of disruption often contributes to distrust of and lack of engagement with professional services , resultiThis paper provides a case study for developing interventions with this ‘hard to reach’ group of young people, it draws on their views and lived experiences to ensure the interventions are salient. We aimed to establish whether the Motivational Enhancement Therapy (MET) and Social Behaviour and Network Therapy (SBNT) interventions were feasible and acceptable to adapt in relation to LAC and other key stakeholders. The adaptation process occurred through a series of stages, which were all qualitative in nature. The steps taken are documented and we present qualitative research findings that illustrate how insights from LAC and care providers influenced the adaptation and manual development of our two evidence based interventions to reduce drug and alcohol use and to be delivered in mainstream alcohol and drug treatment services.Motivational Enhancement Therapy (MET) and Social Behaviour and Network Therapy (SBNT) are existing interventions that have been shown to be effective in decreasing substance use in a range of participants including adolescents –12. MET SBNT is a systematic counselling approach, which utilises cognitive and behavioural strategies to help clients build social networks supportive of positive behaviour change in relation to their substance use and goal attainment . LAC areHowever, whilst both MET and SBNT have been shown to be effective at reducing substance use, less is known about their effect with young people who are looked after by the Local Authority and likely to have more fragmented family relationships. The nature of social networks and how they differ for LAC within the looked after system is paramount to understanding how to effectively engage and work with this group of young people.In accordance with guidance from the Medical Research Council (MRC) on developing complex interventions , we commWithin MET, the therapist could employ strategies to build and strengthen motivation by eliciting self-motivational statements from the LAC and that in doing so, the LAC could resolve the inherent ambivalence about their substance misusing behaviour . When deWithin SBNT, the therapist could employ cognitive and behavioural strategies to help LAC build social networks to help shape positive behaviour change in relation to their goal attainment . When deSemi structured topic guides were developed to discuss the assumptions inherent within the logic models Figs.  and 2 anWe used qualitative methods to establish whether the MET and SBNT interventions were perceived as feasible and acceptable and to adapt them in relation to LAC and other key stakeholders. We proposed to carry out individual 1:1 interviews with LAC and carers and focus groups with professional participants. In reality, for pragmatic reasons we conducted a combination of individual interviews, dyad interviews and focus groups depending on participant’s availability. Table Qualitative interviews were carried out with a purposive sample of 19 LAC. The LAC were identified by their social workers within each local authority area, who acted as the gatekeeper. Social workers provided the research team with contact details for LAC whom had agreed to be contacted. The research team then contacted eligible participants  to discuss the research and arrange an appropriate time to visit and conduct an interview. The purposive sample aimed to ensure diversity with regards to age, exposure to drug and alcohol use and placement type. The final sample was representative of the LAC population so far as there was an equal mix of male and female participants and a range of placement types across the different local authority areas as identified in Table Interviews were also carried out with 3 drug and alcohol workers whom had previously delivered SBNT as part of a previous trial . These iFocus groups and dyadic interviews were held with professionals. Two focus groups were held, one with 4 LAC social workers and one with 6 specialist young people’s drug and alcohol workers. This was complimented with two further dyad interviews with social work staff. The focus groups and dyad interviews enabled us to discuss the original components and principles behind the MET and SBNT interventions and whether they perceived them to be relevant to LAC. They also enabled us to explore the broader therapeutic approaches required to work with LAC, the feasibility of delivering the interventions to LAC and consider potential barriers to delivering the interventions at scale. Data were collected until data saturation was reached.Written informed consent was obtained for all participants, inclusive of assent from LAC under 16 years of age and consent from their corporate guardian. Information regarding the consent procedure and interview process can be found in the SOLID protocol paper . InterviA preliminary thematic analysis was conducted on the data available from the qualitative interviews and focus groups, in preparation for the intervention development workshops with professionals and young people before finalising the adapted MET and SBNT manuals.Transcripts were thematically analysed , in pracThe quotes included in this paper came from young people who have experienced receiving drug and alcohol treatment interventions and/or LAC accessing other services for support surrounding ‘help seeking’ behaviour. Additionally, opinions were sought from professionals who have experienced delivering interventions and engaging with the LAC population.At the outset of this attempt to co-produce and adapt two distinct intervention manuals for SBNT and MET, topic guides were written to focus on each intervention separately and in its own right. What became apparent as an emergent finding is that less emphasis was placed on the specific intervention being delivered and more importance was placed on the ‘key therapeutic factors’ and generic processes of working with LAC. Therefore, the main findings focused on ‘therapeutic relationships’ and ‘engagement and challenges of working with LAC’, which are relevant regardless of the intervention being delivered.The themes and subthemes that emerged from the data within each of these categories are described below and the discussion section outlines how the data collection influenced our manual and training adaptation.“You need to put in the groundwork initially. I think with teenagers you need to gain their trust, you need to work for it. Because if they have been hurt, which they will have been, they will try to push you away. They won’t want to trust you.” The qualities of trust and genuine care were the two main sub- themes that emerged regarding what underpinned a successful therapeutic relationship. Participants, inclusive of professionals and LAC themselves highlighted the importance of building a therapeutic relationship when working to reduce substance misuse. The LAC’s ability to confide in professionals and trust the substance misuse practitioner was a recurrent theme. Whilst trust is recognised as a necessary condition for any caring relationship, it was reported to be particularly important for LAC, whose experiences leading up to their placement in care may have impacted upon their ability to trust others. Professionals acknowledged that LAC often experience disorganised and difficult attachment. This included repeated experiences of their essential needs going unmet, relationship breakdown and abandonment, being let down and broken promises. Professionals displayed a clear understanding of these complex attachment issues and discussed the need to ‘earn’ trust when engaging with LAC;it is not a job because there is no job that makes you work 24 hours a day, 7 days a week and 365 days of the year, but this one does” .“Further, LAC described seeking qualities such as reliability, empathy and partiality, which may have been qualities missing in their early attachments. Practitioners were expected to act in particular ways in order to demonstrate their trustworthiness. Typically this involved the practitioner being reliable; a quality which practitioners reported could be communicated to the LAC in multiple ways within the interaction. One foster carer describes displaying their reliability in terms of being available 24/7, he is permanently ‘on call’ if a young person needs him, he states;“Just by keeping to your word, even little things like keeping your appointments and attending on time, looking into things when you say you’re going to…” .Professional and LAC participants reported that the practitioner’s reliability must be consistent as any inconsistency is likely to build mistrust.“When you work with someone you have to build a bond up first, before you can open up to them…..It’s, well the way I’ve done is just ask questions about them, and then if they tell you, then you know well if they’ve told me this then I can tell them that” .From the perspective of LAC, engaging with services depends fundamentally on the relationship between themselves and their allocated worker. To facilitate the sense of a reciprocal trustworthy relationship, young people explained the importance of ‘working gradually’, wherein at least the first couple of interactions should be dedicated to building a rapport and ‘engaging’ the young person prior to formal sessions commencing. Additionally, this could be shown by professionals not expecting young people to instantly make disclosures, but allowing a positive working relationship to develop first. Self-disclosures where practitioners ‘trade’ personal information were perceived to be beneficial to developing a trusting relationship, whereby the process of sharing information was not completely one sided. Some, examples that young people provided for this were discussing a hobby that the practitioner enjoyed doing or talking about a pet they had. This level of disclosure enable a small ‘trade’ of personal information to be made without divulging any sensitive personal information. LAC reported that such disclosure enhanced their sense of connection to the practitioner as well as their own safety to disclose information.“Myself and his YOT worker had agreed between us that we would have our phones on 24/7. So that if he wanted to get in touch and check in we knew he was okay. So we did, we took turns and he did check in and he did arrange to meet up which was really good” A further quality that LAC sought but did not always feel that they received was that of ‘genuine care’. LAC described having multiple contacts with professionals, with much of the care a child usually receives from a loving family being provided by a professional who is employed to provide such care. The corporate parenting role dictates that safeguarding and risk management take precedent over the provision of emotional support. However, many social workers described going ‘above and beyond’ their role and being available outside of their contracted working hours in an attempt to show they care for the young people in their care.“Any child that comes to live with me, I know they are not mine, however I will work with them, I will play with them, I will live with them and I will do everything to my best ability in every area, in every arena because I want what is best for them.” .LAC were acutely aware of the corporate parenting role fulfilled by the professionals and highlighted the importance of practitioners  whom made them feel like they ‘genuinely’ cared about their welfare. Despite being in a paid position to provide care for young people, foster carers reinforced their attempts to provide the same level of care and support to the children and young people they foster/care for in the same way they would treat their own biological children.“Like Josie talks to me, not like I’m just someone she has to work with, she talks to me like she cares” For LAC, Genuine care involves professionals ‘being available’ when needed, showing empathy, perseverance and providing support  which feels unconditional. For the young people, genuine care was described as stemming from personal investment rather than a professional obligation or remuneration.We had a young man who had been abused by a family member. He was feeling guilty himself about it and thought that we would feel disgusted that things like that had been done. It is letting him see that we are not disgusted. Straight away, I have heard all of this before, you are not the only one. It is not your fault.” .“From the perspective of LAC, a further way of professionals showing that they cared for a young person was to take a non-judgemental approach and to show unconditional positive regard to the young people under their care regardless of the information they were disclosing. This was reinforced by professionals and foster carers, whom reported LAC disclosing information to them regarding historical experiences. Foster carers described having to respond in a sensitive and non-judgemental way.“…my family is ‘f…. up’…really ‘f….. up’. And if I sat there and told someone they’d probably run a mile, they probably would. So that’s why I’ve never really opened up to anyone, cause if I did they probably would run away, do you know what I mean?” This was important to LAC as some participants felt that they may be judged because of their experiences leading up to them being placed in care and elected to not engage for fear that practitioners would not be able to ‘cope’ with their experiences.The above examples highlight the specific skills necessary to facilitate a therapeutic relationship. Both LAC and professional identified additional practical issues and challenges that needed to be address within the adapted manuals.“It was like in a room…and like there’s a table there and it had like little seats round, and like, he was just on about things. Do you know, he didn’t make it very good, like, he didn’t make it very fun and enjoyable kind of thing. It was just like, boring. He was just writing things down that I was saying basically and it just upset me. He just kept on going over it and over it and over it, he was like “so how did that feel? Bla bla bla.” I didn’t really feel comfortable” There was a consensus from all perspectives that traditional one-to-one counselling style interactions are often unproductive for LAC. Typically this was experienced as overly formal for LAC who might find this type of interaction difficult to engage with. Young people commented on how they found it harder to participate in ‘traditional’ formally structured sessions.“That are not many young people who you’ll get to the point where you’re doing that one to one counselling really. It is few and far between. You’re being creative…” .The ability for practitioners to work creatively and use visual strategies such as the ‘node-link mapping’ used in the International Treatment Effectiveness Project (ITEP) and mood cards whilst staying true to the intervention delivery was deemed a successful strategy to engage LAC.“Writing it down or doing it like arts and crafts way because I don’t like just talking and having conversations cause I just get a bit bored and lose track, then I’ll start fiddling about.” Many LAC wanted other strategies and approaches to be used to help them connect with professionals, maintain concentration and become more involved in sessions.“I think what’s coming out here is that with the kids we work with, the drug and alcohol issue is over there, if you like, and a whole raft of other issues are here. As workers we’re dealing with all of these here and that tends to sort the drug and alcohol issues out quite naturally” A further approach deemed necessary when working with LAC was to explicitly acknowledge the complexities of their life due to them being in the care system. This enables a holistic approach to be taken within sessions. LAC identified it was important that goals did not focus solely around substance use. They valued discussions that recognised the difficulties occurring within their lives and facilitated a personalised approach to be taken to meet their needs. Professionals also clearly identified that a bespoke approach has to be taken;“So they might, you know, have contact with their brothers or sisters, you know, it is just they get moved around, and when they are moved around they are vulnerable, they are desperate to have friends or they are desperate to have somebody to call their own…… people get attracted to them who are, I would say, not the type of kids I would want my kids to knock around with” .Frequent placement changes resulted in inconsistent and fragmented support networks for LAC. The transient nature of the LAC population can result in young people being eager to find friends even if that results in becoming involved in unhealthy friendships.“It is quite sad sometimes when they haven’t got anybody in the family, not even an uncle or a cousin or somebody who they can put down as a support really” .This was highlighted as a challenge when working with LAC. Whilst social support networks is an explicit component of SBNT, LAC and practitioners recognised the central part that social interaction and support for change plays in any resolution of substance misuse problems.“My boyfriend and his friends, and there’s a few of my friends. Actually they’ve got their own lives as well, they’ve got their own houses and their partners and they’re all settling down as well, so…there’s not really many people there. When you think about it though, how many of them can you turn to if you’ve got a problem? Cause there’s not a lot” .The challenges of finding appropriate network members was explored, in many interviews LAC struggled to identify someone they felt they could turn to, feelings of not having support or the need to be self-sufficient was verbalised;“There’s two main people I’ve got in my life which provides me with support. One’s my boss, he’s a farm manager, I work with him most days. Another person is the manager of [name of school], he owns the company and he helps quite a lot by, when I moved out of here the first time, he’s the one that made me come back, and let me get my head back” .When young people did identify positive support, it was often people outside of the traditional family support network as would be expected within the LAC population. This in itself could be challenging due to the identified sources of support often being professionals whose ability to provide ongoing or out of hours support is not always practical as would be possible from a more traditional family member.n = 14) all of whom had been involved in step 3 of the process earlier. Four workshops took place with young people (n = 13), none of whom had been involved in the study previously, Table The preliminary findings from the qualitative interviews and focus groups were presented within a series of intervention finalisation workshops that took place to co-produce the final intervention manuals. Five workshops were conducted, one with professionals (n = 5) and non-LAC (n = 8) whom had all experienced accessing specialist drug and alcohol treatment. The decision to include non-LAC was made as we had difficulty identifying LAC who had previously been in treatment and were still contactable. We wanted to ensure we had maximum variation of young people whom had experience of accessing drug treatment agencies to discuss the developed interventions. We held multiple workshops to enable participants to be involved in each active study site without having to travel long distances to take part. The workshops were all held within the well-established young people’s drug and alcohol services involved in the study so participants were in a familiar environment. The workshops provided an opportunity for the research team to present the preliminary findings to participants and then work collaboratively to co-produce the final manuals.Within the professional workshops, participants were split into two separate groups and asked to consider either the MET or SBNT intervention and discuss what the final manuals should ‘look like’. The workshops with young people included both LAC  made recommendations regarding the need for additional resources such as worksheets and exercises to be available to support the training of drug and alcohol workers and to complement the adapted manuals. Practitioners requested appointment cards that identified appointments were for SOLID as opposed to the usual treatment services and a pre-treatment session was requested to enable practitioners to attempt to build a rapport prior to commencing sessions.The MET intervention originally consisted of three sessions and was increased to six to enable more time for a therapeutic relationships to be built. The SBNT interventions originally consisted of eight sessions and was reduced to six sessions, in an attempt to keep the sessions focused and in turn keep LAC interested and engaged in the work being done. However, as the interventions are delivered to meet the young person’s needs, they could be completed in less than six sessions if appropriate. If more than six sessions were required, LAC would be referred into tier 3 structured services for further work to take place.Drug and alcohol practitioners are encouraged to consider a range of approaches within sessions including a mixture of the traditional therapeutic approach, sessions inclusive of creative writing, arts and crafts and/or the completion of more formal worksheets. Allowing a flexible approach to be used in the interventions is hoped to result in LAC engaging with practitioners using a method they feel comfortable with.Following the workshops, thematic analysis of the workshop data took place. The qualitative data collected across the different stages of the formative work were analysed separately in the first instance. However, the data from the initial set of qualitative interviews and the workshop data were also considered in conjunction with each other to establish where findings from each stage converged, offered complimentary information on the same issue and where any data appeared to contradict each other. Once analysis had been completed the final adaptation of both manuals took place. To ensure rigour within the analysis process, a number of strategies were used. We used the professional workshops as a forum to member check our data, 10 of the professional participants were respondents from whom the data were originally obtained. The data were presented at study management meeting to allow colleagues to discuss the data and ongoing communication took place between the on the ground researchers developing the manuals and the intervention authors Professor Alex Copello (SBNT) and Dr. Gillian Tober  to ensure the core components of each approach were retained throughout the adaptation process.process of the interventional development and highlights how the interventions were adapted to reflect the practicalities of working with a LAC population, often presenting with complex needs. The formative work explored multiple contextual components associated with being involved in the care system and participants discussed issues such as stigma, power and lack of control. As far as possible, the manual addressed these issues, specifically revising the training and manuals to focus on the issues of practitioners building trust, providing genuine care, being non-judgemental, working creatively and having treatment goals wider than substance misuse. Whilst it is outside of this process paper to explore the contextual components in depth, a linked paper focusing on the ‘conceptualisation of care’ goes some way to acknowledging the important components of care .The current paper gives a step by step guide, based on the Medical Research Council (MRC) framework, of how to develop and adapt complex interventions  using thKey adaptations made were: the need to focus upon overcoming insecure attachments and mistrust that LAC have experienced by default of being involved in the care system and the need to be more flexible with social network members due to the fragmented nature of available support networks and repeated broken relationships. In a practical sense the need to use creative non-traditional methods to engage LAC who are known to have lower educational achievements than their peers and to overcome their repeated exposed to new workers and services due to moving into new placements. Finally, the need for treatment goals to be wider than substance misuse alone to accommodate the diverse needs of LAC whom are known to have higher rates of co-morbid mental health problems and higher levels of risk-taking behaviours such as drug and alcohol misuse. It was essential that a LAC’s needs should be addressed holistically as substance misuse rarely happens in isolation but often interacts with a wider set of problems.Trust was a recurring theme on behalf of LAC and professionals. Many studies have shown that maintaining and developing positive relationships are highly important to LAC –25. YounThe current qualitative study highlighted the importance of LAC feeling respected and having their voices heard. This translated within the workshops to a co-produced intervention wherein the LAC sets the agenda and pace of work. This is a common finding of research into young people’s experience of service usage , 26 and . Approaches such as Multisystemic therapy (MST), Multidimensional family therapy (MDFT) and Functional family therapy (FFT) have shown that the ability to be flexible regarding the time, place and frequency of client contact is crucial to improving engagement and retention [In response to feedback, hand-outs and worksheets were developed to complement each session and the manual identified how activities could be used to keep LAC engaged both within and between sessions. Due to LAC having lower levels of functional literacy, the use of creative/visual approaches enables LAC to express their thoughts and felling more easily , 33. Theetention , 34, 35.The manual and training were adapted to acknowledge that LAC may struggle to adhere to one of the traditional criteria of a ‘network member’, that of a network member being ineligible if they ‘have an alcohol or drug misuse problem themselves’. This may be problematic as it is known that 25% of LAC in foster care and 42% of LAC in residential care drank alcohol at least once a month  and 11.3The manual still identifies an ideal network member however the training discussed scenarios when the criteria can be amended to enable LAC to bring a supportive individual to sessions. The manual emphasised the importance for LAC to sustain engagement by widening the reach of the intervention beyond the traditional family. This was significant as young people presenting with substance use problems often come from disrupted families and traditional systemic family approaches may be problematic to deliver in such situations . The manthe manuals enabled practitioners to have the flexibility to focus on the young person’s identified goal regardless of whether it was specifically to address their substance misuse. It was essential that a young person’s needs should be addressed holistically as substance misuse rarely happens in isolation but it often interacts with wider problems [Finally, both interventions reinforced the recognition for practitioners to be flexible and responsive to the young person’s needs by designing the manuals in such a way that topics did not have to run in a set order, practitioners could organise sessions and deliver the content in a way best suited to the young person. Regarding SBNT, the original approach of having core and elective topics is designed to allow a flexible approach to be taken, this was emphasised when developing the manual for LAC. Literature identifies that it is crucial to ensure that interventions address issues of concern for the young person rather than following a strict plan that does not address their needs . Additioproblems , 40. TheTo our knowledge this is the first study to describe the process of intervention adaptation with LAC, carers, drug and alcohol workers and social workers to refine and develop two evidence based behaviour change interventions. Overall findings highlight the importance of co-production with this group of young people and suggested that whilst original components of both interventions were feasible to deliver and acceptable, specific adaptations had to take place. Key areas included increased emphasis upon therapeutic relationships, the benefits of using creative non-traditional methods of engagement and identification of treatment goals wider than those narrowly focused on substance misuse. This paper provides an example of using the MRC framework to collect multiple perspectives to refine an intervention to decrease drug and alcohol use and support mental health of Looked after Children in the UK at scale.


The purpose of this intervention study was to develop an educational program for coaches to strengthen the coach–athlete interpersonal relationship in individual youth sport. To obtain data in the qualitative interpretative phenomenology phase, 10 youth sports coaches took part in semi-structured, in-depth interviews. The educational program was developed by integrating psychological, educational and social skills into the educational coaching sessions. The program involved a detailed video analysis, theoretical classes, and individual consultations. The qualitative interpretative phenomenology research design was used and enabled to evaluate the program. The study results revealed that the program had a positive impact on the transformation of the coach–athlete interpersonal relationship in sport. Behavioural, emotional, cognitive, and social strategies changes occured. The quality of the coach–athlete relationship changed: trust, communication, cooperation, encouragement, and a connection between athletes and the coaches appeared. The study’s results showed that the educational program for coaches had a positive effect on the quality of interpersonal relationships between athletes and the coaches and increased positive coaching strategies in youth sport. Coaches are playing an increasingly important and diverse role in sport . The coaDespite the fact that coaches play the most important role in motivating youth, athlete motivation to participate in sport largely depends on his/her personal motivation. Scientific research has shown that some athletes are engaged in sport by external factors, such as pressure from their coach, parents, reward systems, and recognition. Other athletes are involved by curiosity and interest, a desire for growth and improvement, and a desire to master new skills . In ordeThe coach–athlete relationship that contains elements of success and effectiveness is the ideal athletic relationship. The coach–athlete interpersonal relationship includes performance success, as reflected in improving a skill or achieving success, and personal growth, as reflected in experiencing a sense of maturity and satisfaction . Most reGiven that there is a need for applied research to create a better understanding of (1) how the long-term educational program developed for coaches could influence the change in coach–athlete relationship and (2) how the integration of psychological and educational skills into the educational program effects coaching experiences in youth sport. Therefore, the purpose of this six-month intervention study was to develop an educational program for coaches. The second aim was to evaluate the change in the coach–athlete interpersonal relationship in sport based on a 6-month educational program. This study is based on the integration of psychological, educational and social skills into a coaching program and aimed at presenting a 6-month coach intervention program while examining the changes in the coach–athlete relationship in sport.Qualitative research design. Interpretative Phenomenological Analysis method, hereinafter IPA [fter IPA ,17,18, wSelection of research participants. The research participants were chosen from volunteers who answered the invitation to participate: Coaches of an individual sport. Demographic characteristics included a number of research participants, coaches’ gender, age, and education level. Moreover, the demographic data included a sport type. Finally, sport coaching experience in years was included. In the survey that lasted for almost two years, ten stories of coaches were voice recorded. The sample consisted of 10 coaches who were 42 years old in average. Three females and seven males were research participants in this study. All of the coaches were highly educated and were of a higher master degree education level. All 10 coaches had an average of 12 year coaching experience in individual sports of martial arts. The coaches involved in this study were focused on coaching adolescent athletes aged 12–17. Each of the coaches had at least three athletic groups in each age group: 12–14 age of group, 15–16 age of group, and 16–17 age of group. Each group consisted of at least of 10 adolescent athletes. In total, each coach was coaching 90 adolescent athletes in average.Research procedure. Regarding the sensitive topic of analysing coach–athlete interpersonal relationships in youth sports, the researcher carefully planned the research process in the following stages. First, researcher obtained ethical approval from Vytautas Magnus University about the eligibility to conduct the research. Next, the researcher organised a meeting with coaches and provided a detailed explanation about the ongoing research and the program. Finally, coaches’ consent to participate in the study was obtained prior to the planned research. Below, all steps are explained in more detail. With the help of administration of sports clubs, information about the planned survey was announced in seven private sports clubs of martial arts in Kaunas, Lithuania. Each private sport club had 6 coaches on average. Only the coaches interested in the survey collected flyers with the description of the study and researcher’s contact details. The coaches were given all the researcher’s contacts, enabling them to ask questions at any time. Thirteen coaches expressed the wish to participate. However, based on research participant selection criteria—homogeneity, information coverage, and informed consent to participate in the survey—three participants were excluded from the research. The information about the ongoing research and developed educational program was clearly explained to all coaches in the meeting at arranged time. The author of this program, with the help of sports club administration, has organized the first visit. All ten coaches were invited to the meeting. The author of the program described the program in a very careful manner. Research participants were informed about the ongoing research and developed educational program. Research participants were informed about the aim of the program, the content, and the structure of the program. Coaches were informed about the benefits they might gain after the program. Research participants were also informed about the responsibility to take part in the research and the program. All ten respondents were invited for an interview prior the intervention and post-intervention. Questions given to the respondents were formulated in accordance with the research problem. The plan of questions was followed in order not to digress from the research issue and at the same time not to restrict free associations of the respondents and the content of their stories.Interview Protocol Development. The questions given to the research participants focused on the issues raised by the investigation. The protocol served only as a guide in each interview to prevent the researcher from uncontrolled deviation from the analysed topic, and to restrict free associations of the participants and the content of the narrative. Semi-structured interview questions began after the researcher established consent. Next, the participants shared more about themselves, their families, and hobbies. Later, more sensitive questions related to the research emerged, such as “How do you understand the coach-athlete relationship?” or “What difficulties in coach-athlete relationship have you faced during your coaching experience?” The interviews concluded with a neutralizing inquiry about their feelings after the meeting, and an opportunity to ask questions to the researcher.Semi-structured interviews. Information about coach–athlete interpersonal relationships in sport was collected by means of semi-structured interview. This approach is considered to be an appropriate data collection method in which the researcher attempts to get to the depth of meanings and the survey is first of all focused on insights and understanding. Interviews were conducted in the author’s research office, and the schedule was organized in separate individual meetings with coaches, scheduled in advance at a time convenient for all parties. Interviews lasted from 1 h to 1.20 h.Research data analysis. Data analysis was carried out in compliance with the methodological requirements of interpretative phenomenological analysis [analysis . The anaanalysis . At thisanalysis  in orderEthical aspects of the survey. The Survey respondents participated voluntarily and for no remuneration. They did not receive any misleading information regarding research goals or the form of results presentation. The research was conducted by the following principles [inciples : Right fThe ethical principles included obtaining individuals’ consent. The consent included information about the ongoing research. The aim and the purpose of the study were explained. The use of research participant-given information for research purposes was explained. The right to refuse to participate in the research at any time was explained as well. In this sense, the research participant would be excluded from the research and the recorded interview automatically deleted.Research quality assurance. Researcher followed [followed  four prifollowed . ResearcA 6-month coach education program  was devePsychological aspect. An important psychological element of the program included a detailed video analysis of the training class. The aim of this video analysis was to examine the videotaped process of a sport training session, to observe coach–athlete relationship in training sessions. The instructions on how to be prepared to participate in video analysis in the training session were given. All the athletes who participated in this analysis and the athletes’ parents signed an agreement expressing their consent to participate in such analysis. Through detailed observation, the emotions and behaviour of coaches and athletes at training classes were discussed in a workshop session. The videotaped class was also discussed in separate individual meetings with coaches scheduled in advance. The psychological aspect was ensured by involving individual counselling and personal supervisions. A preferred counselling schedule has been identified. Individual coach counselling and personal supervisions included individualized coach experience analysis, and/or specific interpersonal relationship case analysis.Educational aspect. The program involved educational aspect, a theory class led by sports psychologist and sports educator for coaches (once in a month/one academic hour) to help them understand the benefit of the educational coaching process. The following themes were covered in the coach training session: The importance of the coach–athlete attachment in youth sport, the importance of coach’s psychological knowledge in youth sport, the importance of coach’s educational knowledge in youth sport, the importance of coach’s social knowledge in youth sport, involved/overinvolved/not involved coach, and positive/negative coaching strategies in youth sport. The topics were formulated and emerged from the background of systematic scientific literature review. They also emerged from the author’s research background. Finally, the topics emerged from the author’s athletic and coaching practical experience background. The educational aspect of the educational program used for the intervention also involved workshops for coaches, and psychological, educational, and social skills were trained during workshops. The workshops included different situation analysis, video analysis, and group work. A schematic educational program description is presented in Educational skills were trained through the context of theory class, which included 1 topic per month. However, this topic was analyzed in 4 weeks. In total, 6 topics were analyzed in depth. As was mentioned earlier, educational workshops included a detailed video analysis of each case. The educational aspect included group work that was organized one time per week. The group work included a specific case analysis that was based on real coaching practice. For example, each coach represented a specific case or situation in relation to coach–athlete relationship issues. The group analyzed the possible best solution of particular case. In total, 90 h were included in the educational program. In addition, social skills were integrated in psychological and educational aspect. In long term, coach training development communication, cooperation, collaboration, and team work occurred.Results of designed educational program are presented in “It was a very deep look into the coaching. As for me, I always missed this part of my coaching experience. The important moment is that coach-athlete relationship depends on the coach’s attitude towards the athlete, the ability to say tactfully, in a very common sense what you want to say to an athlete, and not too much. Because the “word” could be much stronger than a physical moment.”“I understood now, that the psychological, educational training sessions for coaches need to be continually organized. This six-month program is a first step into the coaches’ professional development. Sports psychologist, sports educator and sports coach should collaborate continuously to achieve the best results.”“Technical, tactical skills are very important. But the psychological moment is the most important, and everything actually starts from this point. If you have a good, secure relationship with your athlete, you know, as a sport professional the technical, tactical part will be successful. That‘s what I realized.”“A coach needs to know a lot. He is a sports psychologist, sports educator, sports coach as a professional; he is a mother, a father, a friend, a colleague, he is everything to the athlete. But what I learned from this program is that to maintain all these relationships you as a coach need to work hard to be the authority to them.”Conversations with coaches revealed that psychological skills were the most important parts of the sessions in the entire six-month program. Prior to the intervention, the coaches expressed their feeling that they lacked psychological skills in their coaching experience. To strengthen athlete motivation was very important to them. The coaches stated that athletes’ motivation to participate in sports is the most important aspect of sports. Some athletes have intrinsic motivation and others do not. Themes such as the ability to inspire the athlete, amotivation, and demotivation appeared in their relation to athlete context. Athlete goal setting and self-determination as important element in sport also were difficult to achieve. Emotional skills such as fair play, and stress management prior, during, and after competitions were difficult to control. As a result, coach–athlete behaviour strategies were weak, which caused such feelings as alienation, disinterest, and relationship distance between the coach and the athlete. Such knowledge is important in strengthening coach-athlete relationship. Higher education helped them to gain generic skills useful in everyday coaching practice; however, the psychological skills need to be developed further:Coaches with a great coaching experience honestly expressed their warm feelings, and that communicating with an athlete is not the same as communicating with a friend or a family member. They must inspire, teach, educate, and communicate. They mentioned that coaching is not a job. It is life. The learning process never stops. The need for developing psychological skills was emphasised. How to act in a certain situation is hard for them choose. Every athlete is a personality. There is a need to look at every athlete as a separate personality. This task requires deep psychological knowledge. Every athlete for a coach means, firstly, raising a thoughtful personality for life, and only the second goal is to inspire sport values, sport education, and technical and tactical sport aspects. They mentioned that a coach for an athlete means a lot. In the long-term, a coach in youth sport becomes like a second parent, an important family member, a positive role model, and a positive authority. In this sense, a coach must be a positive role model for every athlete.“Honestly, I never did any educational meetings with athletes before. The time issue. We, of course, meet and discuss pre-competition session, post-competition session. But such meetings, as you know, have the goal to educate athletes, for example, what is the sporting phenomenon, how not to burn out in sport, what are the drop-out prevention strategies in sport, what is the emotion managing in sport, —we never discussed.”(Coach 3)“I now see how important it is. I actually organized the meeting with athletes as the program suggested. I gave a lecturer, held a seminar for them. They were really interested. Actually, what I felt is that I know so little. I had to prepare, to read information about a particular topic that I want to talk with them, I had to manage time, reflection, discussion. I realized how much I as a coach need to learn first.”The research showed that the expression of the secure coach–athlete relationship depends on how the coach perceives the value of sport and how they transfer this perception into the athlete’s sporting life. The interviewed coaches acknowledged gratefully that the educational part, meetings with athletes, and discussing different topics with their athletes is necessary. However, all coaches emphasized that adding educational sessions to their coaching experience is challenging:Professionalism in every context is highly appreciated. The coaching context is no exception. To be a good professional in a field means to gain deep knowledge, to keep on learning, especially in the education context, in which you have to be prepared to act in a way that this acceptable to each generation. Meetings not only with athletes but also with parents have created a motivational, friendly environment, based on trust and reliability. However, coaches mentioned that organizing educational meetings or theoretical seminars by presenting and educating athletes on how to improve technical and tactical skills were a challenge to them.“The big issue is parents. I want to do my best with athletes, but what I realised that if I want to do my best with athletes, I need to have best relationship with athletes’ parents as well. To communicate with parents is challenging.”“After the educational classes, analysing different situations of positive and negative examples of all three members of the sport, namely coach-athlete-parent, made sense. I now know that responsibility lies upon all three members, not only the coach. That is surprising. Also, what I think, the intervention is strongly needed for the parents’ involvement into youth sport.”“After the program and the sessions on social skills development I learned that the communication and relationship between all the members directly influences the young athlete. It is unbelievable. But it’s true. I thought that close relationship between the coach and the athlete is the most important. But actually you need to see who is around you as well.”Prior intervention research results showed  that coaCoaching is one of those educational contexts in which a coach needs to have educational interaction skills not only to deal with the athlete but also with other important members, such as athlete’s parents, other coaches, and sports organization. Communication skills need to be developed. Research participants reflected that interaction skills, especially with athletes’ parents, has increased. To maintain a positive relationship with athletes’ parents is a challenging issue, mentioned the coaches. After the educational program, the sport environment and relations with other sport participants became more flexible, positive, and friendly.The purpose of this intervention study was to develop an educational program for coaches with the aim to strengthen coach–athlete interpersonal relationship in individual youth sport. The program was developed based on the evidence of scientific research, the program author’s scientific knowledge and her past research, and on her long-term sport and coaching experience. In order to improve the aforementioned aspects, before the intervention the researcher conducted the first qualitative phenomenological analysis. For the researcher, it was important not to bring her own sport and coaching experience while conducting research so that it would not influence the study results. The researcher was highly psychologically prepared without holding any preconceived assumptions regarding its truth or usefulness.The researcher conducted in-depth interviews with coaches in order to find out the most important issues for coaches and the difficulties faced in coach–athlete interpersonal relationship. Prior to the intervention, the following major themes emerged: “the need for psychological skills” with sub-themes such as “strengthening athlete motivation”, “strengthening athlete emotional skills”, and “srengthening coach-athlete behavior strategies”; the second major theme “the need of educational skills” with sub-themes “strengthening interaction skills” and “strengthening interaction skills”; and the third theme “the need of social skills” with sub-themes “strengthening social sensitivity feeling” and “implementation of social values”. Based on these results, the intervention program was developed by the author, who is both a practitioner and a theoretician in the field of sports education and sports psychology.The first theme “psychological skills” described how coach–athlete interpersonal relationship occurred. Coach–athlete motivation increased, and coach–athlete emotional skills in a sports environment, such as emotions pre-competition, during competition, and post-competition, became more stable. Emotion control mechanisms developed. Coach–athlete behaviour strategies, such as harmonious coach–athlete relationship, understanding, trust, and feeling of closeness appeared. Finally, individual supervisions and conversations with sports psychologist enabled to provide support for the coach in understanding the overall coach–athlete relationship. The important finding of this study, namely, the psychological aspect in youth sport, addresses the need for strong psychological skills in the coaching context. This study supports other research findings that the psychological skills are of the highest importance . The psyThe second theme, “educational skills”, describes how coach–athlete interpersonal relationships strengthen after the intervention. Six months is quite a short period to perceive noticeable results. The progress of educational skills improvement was observed. The interaction between the coach and the athlete emerged. “Cautious” interpersonal relationships between the coach and the athlete occurred. The term “cautious”, as the coaches described it, means very thoughtful access to the athlete. They mentioned that after the intervention, they became more diplomatic and tolerant towards athletes and used more tactful access to the athlete. In this sense, self-determination theory helps to explain the results of how coach–athlete relationship occurs and athletes’ decisions in sport. Three basic psychological needs, competence , relatedness , and autonomy  have been strengthened. According to interviewed coaches, theory-based skills were improved. Especially, links between theory and practice occurred. The workshops enabled one to analyse real situations that occur in the sporting environment.Continuing discussion,  presenteThe third theme, “social skills”, describes how coaches improved their skills in the social context. The intervention program integrated psychological and educational skills to improve social skills learning. Social sensitivity emerged after the intervention. Coaches acknowledged the importance of social interaction, which they perceived as social sensitivity, enabling them to develop positive relationship between the members of the sporting activity. Social sensitivity helped to develop social values such as fair play, respect, trust of people, responsibility, and thinking about career opportunities, which, as coaches admitted, still need to be deepened. The research results  show thaThe present study has presented a program on an educational level. The program improved a positive effect on coach education and enabled one to integrate psychological/educational/social skills and make a positive impact on the interpersonal relationship between the coach and the athlete. However, it is important to mention that this program was designed for a 6-month educational period. Therefore, as the results show, there is a need to continue the educational program on a longitudinal level (a period of one or two years or more) in order to evaluate the coach–athlete interpersonal relationships and overall effectiveness of the program. In addition, this intervention program included 10 youth sport coaches. The use of 10 coaches is a limitation, because the sample size is small with regard to the evaluation educational program; even the design is qualitative.The study results revealed that the educational program developed for coaches had a positive impact on the evolution of the coach–athlete interpersonal relationship in sport. The changes in psychological, educational, and social strategies used by coaches were achieved. Psychological aspects such as coach–athlete emotional intelligence, motivation, and behaviour strategies have improved. Educational skills improved through educational interaction with athletes and their parents. Theoretical knowledge has been deepened, resulting in young athletes’ development as well. Improved psychological and educational skills have made a positive impact on social skills learning. The development of social sensitivity and social values have been identified. The study results revealed that the educational program for coaches had a positive effect on the quality of interpersonal relationships between the athlete and the coach and increased positive coaching strategies in youth sport.


Samoa faces a persistently high prevalence of adult tobacco use and few existing cessation support services. Mobile phones are ubiquitous and generally affordable.This study aimed to adopt a text message  smoking cessation program designed in New Zealand  for use in Samoa to assist national objectives in reducing the tobacco use.Using focus groups with smokers and ex-smokers, we explored the context for tobacco use and preferences for SMS text messages. Postintervention focus groups were held after participants received SMS text messages for 1 week. Frequent face-to-face meetings with the primary partner  and key stakeholders contributed to the adaptation process. Participatory feedback and collaboration from stakeholders became an integral part of the cultural adaptation and translation of the program. Furthermore, detailed document analyses were included as part of the formal evaluation of the initiative to explore the core determinants of success in adapting the program to the Samoan cultural context.The SMS text messages evolved remarkably following an iterative process of consultation, in situ testing, revision, and retesting to arrive at an acceptable country-specific version of the mobile smoking cessation program. The SMS text messages retained in the final set were consistent with the theory of behavioral change but reflected both linguistic and cultural nuances appropriate for Samoa. Adapting messages required simultaneous multilevel processes, including complex high-level engagement, between the team and the stakeholders, along with crafting the precise content for (character limited) messages.Receiving cessation support messages through a mobile phone is promising and appears to be an acceptable and accessible mode of delivery for tobacco cessation, particularly in the absence of alternative support. Adapting a text-based program in Samoa requires fastidious attention to the nuances of culture, language, and sociopolitical structures in the country. Mobile phones can deliver programs to support behavioral change ,2, data The increasing use of mobile phones in health care delivery, combined with its accessibility and relative affordability, underpins the growth of mobile-based programs in low- and middle-income countries (LMICs). The advantages of using mobile phones are especially emphasized when access to health services is limited to the lack of resources ,21. InnoTo ensure that mHealth interventions are effective and reflect both changing technology and users’ needs, it is critical to consider the pathways for adapting mHealth interventions to different populations and settings. This paper describes the processes involved in the adaptation of a successful mobile phone-based smoking cessation program from New Zealand for the Pacific country of Samoa. We reflect on the process of adapting an intervention to a cultural environment with technical and resource limitations. Given the near ubiquitous use of mobile technologies in the Pacific region , mobile Samoa, having reached one of the highest rates of mobile phone coverage in the Pacific region in recent years , is wellP<.001) , then they won’t take it seriously. What is important is to scare people and [to say] that it will affect them so that they take it seriously. Even the young ones that have just started smoking, if they get this message, then they’ll know how important it is to stop smoking.Male smoker, aged >25 yearsSome SMS text messages stood out among participants and elicited discussion. For instance, many participants disagreed with the SMS text message that encouraged going to public places to avoid smoking, saying that public places are where smokers congregate and many start smoking.The text about going to public places where there are no smoking, well, there are laws now to not smoke in public places, but it is still going on, like smoking on buses and so on. So, that text might not be appropriate.Male smoker, aged >16 yearsAnother message aroused humor and curiosity; that cigarettes contain chemicals found in toilet cleaner. Although some questioned the validity of that specific message, others suggested that these were the most impactful—clear linkages between smoking, the chemicals, and the risk to body organs.There was one that I got, and I read it to my family, and they thought it was funny and didn’t believe it. The one about the chemicals that are in smoking are also used to clean toilets, and they didn’t believe me. And they said they’re all lies.Ex-smoker, aged >16 yearsParticipants preferred SMS text messages that did not use abbreviated slang language, with some commenting that these SMS text messages will be difficult to understand among older smokers. Furthermore, some participants suggested providing the option for smokers to choose between receiving English and Samoan SMS text messages.The timing of message delivery was also carefully considered within the groups. When asked about the time of the day they prefer to receive the SMS text message, participants broadly agreed that sending messages at midday  and in the evening (when family is around and after dinner) were the most beneficial times.Time that is appropriate is times of meal times, like the morning, lunch and dinner. Then I can read and change my mind about smoking.Male smoker, aged >16 yearsIt’s good at the beginning in the morning and then at the end of the day when people are unwinding, and people are wanting a break and craving a smoke.Female smoker, aged >25 yearsGenerally, participants suggested avoiding times when the messages would be disruptive to important events  or rituals . Most participants reported being satisfied with the timing of messages and the frequency. Some even suggested they would like to receive more messages to assist them to quit smoking.After 1 week of receiving messages, many participants reported that they had reduced the number of cigarettes they smoked. A few said nothing changed, but expressed that the SMS text messages increased their intention to quit.A lot of use of the program for me especially for my family and my relationship with my wife. Because it has given me good thoughts and saving money…I feel better now…I have reduced smoking because it is cheaper, and better for my family. It is important for all Samoans to stop smoking.Male smoker, aged >25 yearsThe majority of participants who received the messages were positive about the potential of the program in assisting them to quit smoking. Many felt that, in the absence of any alternative tobacco cessation support , messages were likely to be helpful in prompting thoughts about quitting.Samoans take a while to change because of the way they feel, and it will take a long time to change, but the program is there and helps straight away, and so the program is quicker in helping quit attempts, when they get text messages.Male smoker, aged >16 yearsPhone sharing in Samoa and the close connectivity with family was believed to help in spreading the message. A number of participants reported that they shared the SMS text messages with family or friends, through either actual forwarding the SMS text message or relaying the content of the SMS text messages to family and friends.I think that this programme is good and so if it is good for me, then it is good for my family and friends. I shared it with others.Female smoker, aged >25 yearsThe cultural translation and adaptation of the STOMP program was a necessary first step to implementing an mCessation program in Samoa. The value of undertaking a cultural translation cannot be underestimated, with strong evidence of its marked contribution to the acceptability and effectiveness of mHealth interventions ,44,45. TA sample of Samoan smokers and ex-smokers were involved in the process of cultural translation and adaptation of a mCessation tool designed for use in Samoa. Smokers were essential as key informants on design-related decisions such as which messages to include or revise and the timing of message and themes highlighted in the SMS text messages . Previous qualitative analyses affirm the critical role of the social environment, familial connections, including smokers, and perceived barriers and motivations for quitting; this led to minor revisions of the original STOMP messages to include more reference to family , and changes to suggested activities and snacks (reduce craving to smoke). Participants identified when cravings to smoke were the highest and when SMS text messages were most useful in providing timely encouragement. The positive response of participants to the program, including the increased focus on quitting or reducing the consumption of tobacco products, was consistent and provided modest evidence that Samoans smokers are likely to use the mCessation program if the program is scaled up and made available as an option for smoking cessation.One challenge during the initial translation was to retain the integrity of the message while ensuring that the messages were kept within 160 characters. As Samoan words are typically lengthier than their English equivalent, alternative words were selected.The involvement of key stakeholders and potential implementers of the mCessation program was critical for the formative linguistic translation and subsequent refinement of the SMS text messages. Colantonio et al  conducteAn important aspect of our cultural adaptation process and one of the strengths of this study is integrating both a “bottom-up” and a “top-down” approach; this process underscores the vital role of the end user of mHealth tools, in this case smokers, to provide inputs about the shape and design of the adapted program. It also recognizes the involvement of key stakeholders who can determine the local acceptability and appropriateness of the intervention. Another strength of this study is partnership with the Ministry of Health Samoa to undertake the process of adaptation and the fact that this work reflects the reality of adapting an SMS text message program for a limited-resource environment.A local coinvestigator, fluent in Samoan, conducted the interviews. Although this adds strength to the integrity of the data collection, it might have introduced a social desirability response, owing to the tendency to offer affirmative opinions when researching within socially connected group settings.The aim of this study reflects an appreciation that culturally adapted messages will increase engagement, a predictor of the positive impact of SMS text message programs on health ,49. SimiThe current provision under the Samoa Tobacco Control Act (2013) covers smoke-free environments, tobacco advertising, and plain packaging . However


The gap between the supply and demand of organ donors is substantial, causing patients to suffer from long waiting times. Moreover, the lack of registrations places a burden on family members and medical professionals when an unregistered individual dies. This article describes a cluster randomized controlled trial (CRCT) study to assess the effectiveness and quality of implementation of a web-based program aimed at encouraging lower-educated adolescents to register a well-informed choice about organ donation, regardless of it being as a donor or not.The program will be delivered by teachers at schools for Intermediate Vocational Education in the Netherlands. The effectiveness will be assessed in a CRCT design with post-test only using self-administered questionnaires for the primary outcome (i.e. intention to register). Classes will be matched to improve equivalence of groups. From each pair of matched classes, one class will be randomly assigned to the experimental condition, and the other assigned to the control condition. Students in the control groups will fill in the questionnaire before receiving the program, while the experimental groups will do this afterwards. A post-test design prevents the risk of testing bias. The required sample size is 14 schools, with 10 classes per school and 13 unregistered students per class. The questionnaire assesses demographics, behavioural determinants , intention to register (as a donor) and registration status. Six months after delivery, registration status will be assessed again. Additionally, a process evaluation will be conducted to evaluate the quality of implementation using both qualitative (i.e. semi-structured interviews) and quantitative  methods.Findings of the study can help to further improve the program and serve as a basis for a solid dissemination plan. Moreover, the study will provide insight into (change in) determinants of registration and donorship and the translation of research into practice of school-based health promotion interventions, which can serve as an example for others.NTR6771. Registered on 24 October 2017. This is version 2 of the protocol (5 November 2017).The Dutch Trial Register, The online version of this article (10.1186/s13063-018-2927-6) contains supplementary material, which is available to authorized users. Despite an increase in the number of organ donors and successful transplantations in recent years, there is still a substantial gap between the supply and demand for organ donors. As a result, patients suffer from long waiting times or even die while waiting for an organ .One of the many efforts to increase the number of registrations is a yearly initiative to encourage 18-year-olds to register their choice (irrespective of whether they want to be a donor or not). In the year after adolescents turn 18, they receive a letter from the Ministry of Health, Welfare and Sport asking them to register their choice. This led to a response rate of 33.0% in 2016, of which 73.9% gave permission for organ donation . To incrpositive/negative outcome expectations), people’s expected social reactions to performing that behaviour  and beliefs about their own ability to perform this behaviour (self-efficacy expectations). Several determinant studies and pilot tests led to the development of the three educational components of the program: (1) videos to elicit discussion about positive and negative outcome expectations of organ donation and registration, (2) working with an interactive computer program with tailored feedback, and (3) practicing with completing a registration form [Reubsaet and colleagues made an effort to educate adolescents about organ donation and registration by designing an educational program for high school students. The main aim of their program was to increase the number of registrations, not necessarily the number of organ donors. The social cognitive theory (SCT) of Bandura was the main underlying theory during the development . SCT desion form –10. Thision form , after wion form . Moreoveion form .Another desirable adaptation regards the target group of the program. As the original program was only used among high-school students, lower-educated students were not reached. Lower-educated students have left high school by the age of 16 (as opposed to 17–18 for higher-educated students) and usually continue their education at Intermediate Vocational Education (IVE) schools . IVE schAdjustments had to be made to make the website suitable for lower-educated students as well. Firstly, textual changes were made, as students at IVE schools score lower on reading competencies than high school students; 20% of the students that start their IVE trajectory score even lower than the minimal reading level required for civic integration . TherefoAdapting the web-based educational program of Reubsaet and colleagues to lower-educated students and implementing it in IVE schools throughout the Netherlands could help reach a larger group of adolescents and therefore increase the number of registrations. As the program is now web-based and applied to a different target group, it is important to study its effectiveness. This will be done in a cluster randomized controlled trial (CRCT) with post-test only in IVE schools spread over the Netherlands. In addition, a process evaluation will be peformed to determine the quality of implementation during this trial. Combining an effect and process evaluation will give insight into the effects of the program and how these effects were achieved. This article gives an overview of the different components of the program and provides a detailed protocol for the anticipated evaluation study.The effect evaluation aims to give insight into the effect of the program on behavioural determinants, the intention to register (as an organ donor) and the actual registration behaviour itself. Attitude, self-efficacy, social outcomes and knowledge will be assessed as behavioural determinants.reach, dose delivered, dose received, fidelity, context  and reasons for fidelity and dose. These levels are inspired by the model of Steckler and Linnan [With the process evaluation we aim to gain insight into how the program was implemented. The process evaluation relies on four different data sources: questionnaires from students, logbooks, interviews with teachers and user data from Google Analytics. The use of data triangulation enables different data sources to complement one another. This provides an overview of the implementation of the educational components on six levels: d Linnan . AdditioThe web-based program consists of three main elements: video fragments followed by group discussions, quizzes with tailored feedback and an exercise to fill in an organ donation registration form. The website is hosted by SIDVO, which is a foundation that aims to develop, evaluate and distribute organ donation education. The elements will be provided to the students during two 50-min lessons at school. At the end of the program, students are expected to be able to make a well-informed decision about organ donation registration and will be encouraged to register this choice.Lesson 1 consists of four video fragments followed by group discussions. Each video deals with an aspect of organ donation and registration in which both positive and negative outcome expectations are included. The videos are designed to elicit discussion among students about brain death, the possibility to help other people by donating your organs, discussing the subject with others and the importance of registering in general . Teachers will be provided with a manual to facilitate discussion after each video in which students have the opportunity to share their opinions and beliefs. This activity aims to increase involvement, encourage positive beliefs and counterbalance negative beliefs.Lesson 2 combines two program elements. First, students will individually work with the website. The website provides the participants with two quizzes. One quiz will mainly focus on students’ knowledge, while the other one will focus on their opinions. The knowledge quiz reveals a score on a scale from 1 to 10 and the correct answers to the questions after completion. In the opinion quiz each question will be followed by tailored feedback. Participants will receive information that is personally relevant and fits their needs. The main goal of the quizzes is to teach participants about organ donation and registration and give them tailored feedback on misconceptions they might have. The second part of the lesson will be spent on an exercise on completing an organ donation registration form in order to enhance self-efficacy. Students will be provided with a copy of an organ donation registration form or use a digital version, whatever option is most convenient. The aim is to give students an enactive mastery experience, which increases their self-efficacy and therefore increases the intention to fill in a real organ donation registration form.This article was written in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist  and quantitative  methods, both during and post-delivery.The educational program will be provided by the teachers in IVE schools during regular classes. They will receive a link via e-mail prior to the start of the study. With this link, both teachers and students can reach the website. Before the first lesson, the control group will complete the effect evaluation questionnaire. All participants will then receive lesson 1, with the video fragments and group discussions. During the next session, they will both receive lesson 2a, the quizzes with tailored feedback, and lesson 2b, the exercise on completing an organ donation registration form. Teachers will have the freedom to provide the lessons whenever it fits their schedule, but we expect that in most cases lesson 2 will be delivered within 1 or 2 weeks after lesson 1. After the whole program is delivered, students in the experimental group will fill in the evaluation questionnaire. Six months after the implementation of the program, participating students  will receive a follow-up questionnaire during class to measure their registration behaviour. New control classes will then be recruited to compare the registration behaviour of students who received the program with that of students who did not. Data for the process evaluation will be gathered partly during the program delivery and partly after. During the program delivery, data will be collected on usage , while after the program delivery, reasons for particular usage behaviour will be assessed (e.g. by means of interviews). Moreover, students in the experimental groups will complete a process evaluation questionnaire after the program is delivered.The program will be evaluated in a school setting. More specifically, IVE schools throughout the Netherlands will be invited to participate in the program through various channels. In particular, teachers teaching the course ‘Citizenship’ will be approached, as organ donation fits with the content of this course. IVE schools typically teach lower-educated adolescents from the age of 16 until the early 20s, but students from all ages are welcome. Older students will therefore be automatically included in the sample as well. Students in IVE can choose from a variety of disciplines, both manual and non-manual. There are four levels within IVE, but the educational level is generally low as opposed to college or university education.As participants will be recruited via their schools, they are not approached individually. Therefore, no inclusion or exclusion criteria are set on the individual level. On the class level, only students in IVE levels 2, 3 and 4 are included in the study. Level 1 is also known as entry training. Students in this level did not graduate from high school; therefore, we cannot guarantee they will be able to participate properly in the program due to a large variety in cognitive abilities at this level.Data from a preparatory study in the same target group  and the http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6771). Participation of teachers and students is voluntary, and they will provide written (students) or verbal (teachers) informed consent. Participants will be informed about the study, the opportunity to withdraw their consent at any time and the anonymity of the study and will be provided with contact information in case they have any further questions.The study was approved by the Ethics Committee of the Faculty of Health, Medicine and Life Sciences on 23 October 2017 (reference number Steenaart/231017) and registered at the Dutch Trial Register , one for the effect evaluation (questionnaire E) and one follow-up questionnaire (questionnaire F). For the process evaluation, only students in the experimental condition will receive a questionnaire (questionnaire P) in which they are asked to evaluate the program after the second session. This questionnaire will assess the The questionnaire for the effect evaluation (questionnaire E) will be completed before (control condition) or after  the program delivery. The primary outcome will be the students’ intention to register (yes/no). Students who answered ‘yes’ to this question will be asked to specify the decision they would like to make , which will be dichotomized into intention to become a donor or not. All students will also be asked about whether they already registered a decision (yes/no) and, if yes, the choice they made (see the above-mentioned options). Only unregistered participants will fill in the intention question. Additionally, questions are included to measure attitude, self-efficacy, knowledge and social outcomes. These behavioural determinants are the main focus of the educational program.Finally, all participants will receive a follow-up questionnaire (questionnaire F) after a period of approximately 6 months to measure their registration behaviour. As official registration records are private, participants will be asked whether they registered their choice since receiving the program and, if so, what choice they registered.Teachers will be asked to keep track of a logbook during the two sessions. This logbook will consist of a simple checklist in which they can tick the boxes of the components they delivered during the session. Moreover, they will be asked to indicate the time spent on the components and rate their satisfaction with the lesson. Finally, there will be room for additional comments in case they encountered difficulties during the implementation of the lessons.All participating teachers will be invited to elaborate on the facilitators and barriers of implementation of the lessons during a semi-structured interview. Data from the logbooks will be used as an input for the interview guide, as well as the diffusion of innovations theory . The topThe usage of the website will be monitored by Google Analytics. This quantitative measure gives us the opportunity to assess participants’ behaviour on the website objectively. The potential of using this method in the process evaluation of Internet-delivered interventions has been demonstrated before . The datThe first aim of this study is to investigate the effectiveness of the educational program on the intention to register a choice . All data for the effectiveness are gathered from questionnaire E. Secondary outcomes will be the choice students intend to make (yes or no donation), behavioural determinants and finally their actual registration behaviour 6 months after receiving the intervention. The differences in outcomes between the intervention and the control group will be analysed using multilevel regression models, taking into account that students are nested within classes which in turn are nested within schools. Besides intervention group, several demographic characteristics are included in these models , as they are expected to be associated with the outcomes.As a post-test only design was used, there are no missing data in terms of participants dropping out in between measurements. Therefore, when comparing the experimental and control groups, missing data will not be an issue—we have all data from participants who agreed to participate. The mixed model analysis is then valid under the assumption of missing at random (MAR). However, when correcting for covariates, missing could become an issue, as participants can skip items in the questionnaire. This will be dealt with using multiple imputation (MI).The second aim is to analyse the implementation of the program. Interviews will be audio-recorded, and a transcript will be written from each interview. The transcripts will be marked with labels using open coding. These codes will be categorized (selective coding), resulting in matrices in which facilitators and barriers of the implementation will be identified. Quantitative data from Google Analytics, the teachers’ logbooks and students’ questionnaires (questionnaire P) will be used for descriptive analyses to provide insight into how the program was used, delivered and received.All data will be stored on a secured service and will only be accessible by the study team. A data entry check will be performed on the data from the questionnaires; range checks will also be performed. The interviews will be coded independently by two researchers.This protocol describes a study to evaluate both the effectiveness and implementation of a program aimed at encouraging lower-educated adolescents to make a well-informed decision about organ donation and to register this choice. The study is strong in combining several methods and a variety of data sources. The data triangulation serves two main goals: confirmation of findings and completeness . The comThere are also possible pitfalls of the study. However, by acknowledging them beforehand and taking them into account during the execution, risks can be limited. A threat during the execution of the program is the possibility of contamination. If students in the experimental group receive the program before students in the control group, students in the control group could hear about the content, biasing their answers on the evaluation questionnaire. Ideally, students from both groups (within one school) will receive the program simultaneously. However, in many cases, we expect this to be difficult due to organizational reasons and because often these classes are being taught by the same teacher. If students in the control group hear about the content before filling in the baseline questionnaire, this could influence their answers in the direction of expected intervention effects and therefore most probably lead to an underestimation of the program effect in the end.Finally, the effectiveness of the program in terms of registration behaviour is difficult to measure. As official organ donation registration records are private, no objective data can be gathered regarding the actual registration numbers of participants. The intention to register will be measured directly after receiving the program. To gain some insight into the registration behaviour, participants will be asked about their registration status 6 months after receiving the program. The registration behaviour will thus be based on self-reported registration status. This is, however, the best possible option concerning the circumstances.The findings of the study can help further improve the program and function as a guideline for a solid dissemination plan. Results from the process evaluation will show how the program was implemented and how this can be improved in the future. The interviews with teachers give further details on circumstances that should be taken into account when disseminating the program to a larger scale. Moreover, the study will provide insight into the translation of research into practice of school-based health promotion interventions, which can serve as an example for others.Currently, the trial is ongoing. Recruitment of classes started at the end of 2017 and was completed in June 2018.Additional file 1:Evaluation framework. (DOCX 21 kb)Additional file 2:SPIRIT checklist. (DOC 122 kb)


AT-rich interactive domain 1A (ARID1A) and AT-rich interactive domain 1B (ARID1B) are subunits of the SWI/SNF chromatin complex. ARID1A is a tumor suppressor gene that is frequently mutated (46%) in ovarian clear cell carcinomas (OCCC). Loss of ARID1B in an ARID1A-deficient background eliminates the intact SWI/SNF complex, indicating that ARID1B is essential for the formation or stabilization of an intact SWI/SNF complex and, thus, the survival of ARID1A-mutant cancer cell lines. In this study, we investigated the clinicopathologic and prognostic relevance of ARID1B in OCCC by immunohistochemical analysis of 53 OCCC patient samples and loss-of-function experiments in OCCC cell lines. We also examined whether ARID1B could be a therapeutic target or prognostic biomarker in OCCC. siRNA-mediated knockdown of ARID1B in an ARID1A-mutant cell line significantly decreased cell growth, whereas concurrent depletion of both ARID1A and ARID1B was required to decrease wild type cell growth. In the immunohistochemical analyses, low ARID1B level was frequent in samples lacking ARID1A and was associated with shorter progression-free survival. This is the first report demonstrating that a low ARID1B level could be a marker of poor prognosis in OCCC. Moreover, the correlation between the loss of ARID1A immunoreactivity and reduced ARID1B levels indicates that ARID1B could be an attractive target for anti-cancer therapy. AT-rich interactive domain 1A (ARID1A) is a novel tumor suppressor gene that is frequently mutated in OCCC; ARID1A mutations were identified in 55/119 (46%) OCCC patients in one study with a strong correlation between OCCC and loss of BAF250a protein and the presence of ARID1A mutations [Ovarian cancer is the most lethal gynecological malignancy in the world  and its ARID1A can affect the expression or stability of other SWI/SNF complex subunits. It was recently reported that inactivating mutations in ARID1A create a dependency on ARID1B [ARID1A and ARID1B alleles are frequently co-mutated in cancer, but ARID1A-deficient cancer retains at least one functional ARID1B allele [ARID1B is essential for stabilizing the SWI/SNF complex in ARID1A-mutant cancer cells.ARID1A is a Switch/Sucrose non-fermentable (SWI/SNF) chromatin remodeling complex subunit that regulates many cellular processes such as development, proliferation, differentiation, DNA repair, and tumor suppression . Mutation ARID1B . ARID1A n ARID1B . Howevern ARID1B  and funcn ARID1B  in develB allele . This suIn this study, we investigated the clinicopathologic and prognostic roles of ARID1B in OCCC by immunohistochemical analysis of ARID1B expression in 53 OCCC patient samples and loss-of-functions experiments in OCCC cell lines. We also examined whether ARID1B can serve as a therapeutic target or a prognostic biomarker in OCCC.ARID1A mutations was used in this study [ARID1B in ARID1A-mutant  and wild-type (ES2) cell lines reduced ARID1B protein level   .We examined the clinical significance of low and high ARID1B expression in OCCC. There was no significant association between ARID1B expression level and FIGO stage, cancer antigen (CA)125 level, patient age, endometriosis, or residual tumor status .p = 0.044, log-rank test) , CA125 level , residual tumor diameter ≥2 cm , and low ARID1B expression  were correlated with shorter progression-free survival (p = 0.0446) and low ARID1B expression were significantly associated with shorter disease-free survival (p = 0.03) for  a. A univsurvival . When th.03) for .We examined the prognostic significance of low and high ARID1B expression on overall survival but found no correlation between ARID1B level and overall survival b.ARID1A is one of the most frequently mutated genes in many cancer types, particularly ovarian, breast, gastric, and lung cancers [ARID1A and ARID1B involved in chromatin remodeling. ARID1A and ARID1B are typically co-expressed in cancer, but cancer driven by ARID1A mutation retains at least one functional ARID1B allele [ARID1A mutation and the role of ARID1B can lead to the development of more effective treatments for ovarian cancer.The incidence of OCCC is increasing at a higher rate in Japan than in Europe or the United States . OCCC ha cancers . Mutatio cancers ,15. Saus cancers  and FujiB allele . EstabliARID1A mutations. SiRNA-mediated knockdown of ARID1B suppressed cell growth in ARID1A-mutant but not the wild-type cell line  harboring ell line ; in the d ARID1B . These rARID1B knockdown suppressed growth and colony formation of ARID1A-deficient ovarian cancer cell lines [ARID1A and ARID1B mutations were detected in the undifferentiated components of approximately one-quarter of dedifferentiated endometrial and ovarian carcinomas [ARID1A-deficient background can disrupt SWI/SNF complex activity, thereby contributing to the development and progression of human cancers.A previous study reported that ll lines . Concurrrcinomas . ARID1A p = 0.0446) and low ARID1B expression were significantly associated with progression-free survival . Six-12 cycles of this combination regimen was administered by all patients. All patients were administered adjuvant chemotherapy. Acquisition of tissue specimens and clinical information was approved by the institutional review boards of Shimane University and Serrei Hamamatsu General Hospital. Paraffin tissue blocks were organized into tissue microarrays made by removing 3-mm diameter cores of tumor tissue from the block. The cored area was selected by a gynecological oncologist (KN) and pathology technician (KI) based on review of H&E-stained sections.Formalin-fixed, paraffin-embedded tissue samples of 53 OCCC patients were used in this study. Samples were obtained from the Department of Obstetrics and Gynecology at the Shimane University Hospital and Seirei Hamamatsu General Hospital. Diagnoses were made based on conventional histopathologic examination of sections stained with hematoxylin and eosin (H&E), and tumors were classified according to World Health Organization criteria. Tumors were staged according to the International Federation of Gynecology and Obstetrics (FIGO) classification. Cytoreductive surgery, along with adjuvant platinum and taxane or CPT-11 chemotherapy, is the primary mode of treatment for patients  . Immunohistochemical detection of ARID1B was performed on the tissue microarrays and 3 of each core were included at 1:800 dilution followed by the peroxidase method using the EnVision + system . After antigen retrieval in sodium citrate buffer, slides were incubated overnight at 4 °C with antibody and then examined under a light microscope by two researchers who were blinded to the clinicopathologic factors. ARID1B immunoreactivity was scored by the two investigators as follows: density, 0 = undetectable, 1 ± weakly positive, 2 ± moderately positive, and 3 ± intensely positive; and range, 0–100%. The two scores were multiplied and those <100 were considered low, whereas those ≥100 were considered high.OVISE, OVMANA, and OVTOKO OCCC cell lines were obtained from the Japanese Health Science Research Resources Bank . The OV207 OCCC cell line was a gift from Vijayalakshmi Shridhar . ES2 and TOV-21G CCC human ovarian cancer cell lines were obtained from the American Type Culture Collection .ARID1A and ARID1B were purchased from Santa Cruz Biotechnology . Cells were seeded in 6-well plates and transfected with siRNA using Oligofectamine reagent , and collected 48 h later for western blot analysis of ARID1A and ARID1B protein levels.Short interfering (si) RNAs against OVISE, OVMANA, OVTOKO, OV207, TOV-21G, and ES2 cells were used for western blotting. The cell pellets were dissolved in Laemmli sample buffer  to obtain the cell lysates. From each lysate, the total proteins were loaded  and separated using gels containing 10% Tris-glycine sodium dodecyl sulfate polyacrylamide , and the bands were electrotransferred to an Immobilon-P polyvinylidene difluoride membrane  that was probed with anti-ARID1B antibody  followed by peroxidase conjugated anti- rabbit immunoglobulin .The same membrane was then probed using an antibody that reacted with glyceraldehyde 3-phosphate dehydrogenase  as a loading control. Protein bands were visualized using a chemiluminescence kit .Cells were seeded in 96-well plates at a density of 3000 cells/well. Cell number was indirectly determined with the 3--2,5-diphenyltetrazolium bromide) tetrazolium (MTT) reduction assay  96 h aftt test was used to evaluate the statistical significance of the results of the MTT assay using SPSS statistical software . p values <0.05 were considered statistically significant. Fisher’s exact test was used for comparisons of categorical data. Overall survival was calculated as the time between disease diagnosis and death or last follow-up. Kaplan-Meier curves were used to plot the survival data and log-rank tests were performed to determine the statistical significance of survival differences. Cox proportional hazards model was used for multivariate prognostic analysis. Data were excluded when patients did not continue to follow-up.The ARID1A-mutant OCCC. Our most important finding is that low ARID1B expression was associated with shorter progression-free survival. This is the first report demonstrating that low levels of ARID1B protein can serve as a marker of poor outcome in OCCC patients. We also found a significant correlation between the loss of ARID1A immunoreactivity and reduced ARID1B levels, suggesting that ARID1B could be a target for anti-cancer therapy.In conclusion, our data demonstrate that ARID1B plays an important role in the growth of