Background: Children and youth are facing three major challenges: (1) poor mental health, (2) physical inactivity, and (3) lack of school readiness. Fundamental movement skills (FMS) and social–emotional learning (SEL) are two developmental domains that are associated with each of these challenges. Currently, there is little focus on interventions that target both FMS and SEL. Thus, the purposes of this study were to: (1) examine the acceptability and feasibility of an FMS and SEL program (Move 2 Smile) and (2) assess the impact of Move 2 Smile on FMS and SEL in children.Methods: An exploratory, pilot study using a within-subjects design was conducted. Descriptive statistics were computed to assess the acceptability and feasibility of the Move 2 Smile program. Changes in FMS and SEL were analyzed using a paired sample t-test. A focus group was conducted with parents to gain feedback after the program ended.Results: Eleven children  participated, with families attending 80% of the sessions. The children and parents rated the enjoyment of the program 4.1/5 and 4.7/5, respectively. The instructor rated the children's perceived enjoyment 4.6/5 and feasibility of the sessions 4.7/5. Parents engaged in the FMS take-home activities once per week and the SEL activities three times per week. The intervention had a non-significant small to medium effect on FMS , a significant large effect on social skills  and emotion expressiveness , and a non-significant small to medium effect on emotion knowledge  and emotion regulation . The results from the focus group suggest that parents and children enjoyed the program and that the program was useful and effective at impacting FMS and SEL.Conclusions: This intervention is one of the first to intentionally target both FMS and SEL. Children, parents, and instructors deemed this program as acceptable and feasible. These preliminary findings warrant future evaluations of Move 2 Smile, including a randomized controlled trial. Children today face at least three critical issues that can have long-term adverse effects on their health and development. Firstly, ~14% of children and adolescents are suffering from mental health problems, such as anxiety and depressive disorders, which can have a profound influence on well-being and social participation , after aTwo critical developmental domains that are hypothesized to underpin these broader issues are fundamental movement skills (FMS) and social emotional learning (SEL). With respect to motor development, the attainment of FMS such as running, jumping, and catching allows for a child to engage in more complex movement skills and, therefore, may increase opportunities for participation in PA . For exaBoth FMS and SEL are considered key components of school readiness . Given tGiven the interrelatedness between FMS and SEL and the impact they both have on mental health, PA, and school readiness, it would be logical to intentionally target these domains together in one program in preschool-aged children. While existing preschool interventions likely influence multiple domains of development, very few interventions are designed to intentionally target more than one aspect of development. Without specifically embedding activities that target domains of development that have been shown to be interconnected, these programs fail to address the complexity of the challenges our children face. Targeting multiple domains of development allow interventions to address larger, more complex issues like poor mental health, physical inactivity, and lack of school readiness.Move 2 Learn program that targets motor and pre-literacy skills simultaneously  lab at McMaster University adopted a multicomponent approach and developed the aneously , 18. ThiMove 2 Learn program by introducing SEL into its program design and content. Activities aimed at developing SEL replace the reading skill component in Move 2 Learn. Capitalizing on the multicomponent structure of Move 2 Learn, this new program, Move 2 Smile, will target two of the core contributors of poor mental health, physical inactivity, and lack of school readiness: FMS and SEL. The primary objective of this study was to determine “proof-of-concept” as outlined by the ORBIT model for behavioral interventions in Phase IIA  and the instructor would rate the sessions as feasible . Although this study is exploratory in nature, it was hypothesized that children would improve their movement skill levels following the completion of the Move 2 Smile program  post-intervention testing, and (4) parent focus group. According to the ORBIT model for developing behavioral interventions proposed by Czajkowski et al.  recruitment and baseline testing, (2) i et al. , this stChildren and parents/primary caregivers were recruited through preexisting relationships between the INCH Lab and the University of Toronto Junior Blues Program along with recruitment across the Greater Toronto Area (GTA) in day cares, EarlyON centers , and community centers. In order to be eligible for this study, participants must (1) have been aged 3 years 0 months to 4 years 11 months, (2) not have had a preexisting intellectual or physical disability, and (3) have been free of any health condition  that would prevent safe participation in the intervention.The intervention took place between February and April of 2019. Parents and children participated in each session jointly. The sessions were 60 min in duration and included three components: (1) direct movement skill instruction, (2) free play, and (3) SEL activities. See The first component of the intervention (25 min) focused on movement skill development and was divided into four sections . The intervention focused on three categories of FMS: balance, locomotor, and object manipulation skills. Each week focused on a different FMS and was taught using single-step skill acquisition strategies . This method of teaching FMS has been shown to elicit significant, positive changes in FMS in preschool-aged children . MovemenThe first 5 min consisted of a whole body warm-up where the children and parents formed a circle and performed the “beanbag boogie” to music. The “beanbag boogie” is a children's song requiring children to move in different ways  and balance a beanbag on different parts of your body . The next 20 min consisted of two blocks of movement skill development and an obstacle course. During each movement block, the instructor would demonstrate a skill  and then the parent/child dyads would spread out across the room to practice. Each block of skill development would progress in difficulty; for example, in the catching lesson, the parent/child dyads would begin with catching a big ball with two hands and then, in the second block, move to catching a small ball with two hands and then catching with one hand. During this time, the instructor and the volunteers would circulate around the room to help progress and regress the skills to maintain a mastery climate as well as provide tips to perform the skills better. After the two movement skill blocks, the children participated in an obstacle course that emphasized that week's skill combined with the skills they learned in the weeks prior. Children went through the obstacle course three to four times with their parents before moving on to the next component of the intervention.The next component of the intervention consisted of 10 min of unstructured free play (not involving the parent/guardian). The children were given access to a variety of different toys  to engage with, and no direct instruction took place during this time. The session instructor and the volunteers were asked to avoid initiating play with the child, but rather follow the child's lead.The last component of the intervention consisted of 20 min of activities directly aimed at SEL. Following free play, the children and parents sat in a circle around the instructor to begin the SEL lesson. Depending on the activity, the children/parents would remain in the circle for a group lesson or the dyads would spread out across the room and complete the activities separately. In total, five components of SEL were targeted throughout the 10-week intervention: prosocial behavior, problem solving, emotion regulation, emotion knowledge, and emotion expressiveness. These components were chosen as they have been highlighted in the literature as key components of SEL that result in positive development across the life course , 25. SeeAt the end of each weekly session, the parents were provided with a one-page sheet that outlined the FMS and SEL activities that they performed during that session. This sheet included information on how to properly execute/teach the skills as well as some suggestions on how they could practice the activities at home. The parents were also sent home with any materials they used during the SEL component of the program. For example, the parents were allowed to keep the emotion bingo cards that were used in week 10.Move 2 Smile intervention as rated by the children, parents, and instructors. Additionally, outcome measures were chosen to examine changes in motor, social, and emotional skills as a result of participating in Move 2 Smile.Outcome measures were chosen to assess the acceptability and feasibility of the A demographic questionnaire was administered to the parents at their baseline study appointment. The questionnaire included information regarding age, sex, race/ethnicity, parental education and occupation, and household income.Move 2 Smile program. In addition, the parents/guardians who accompanied the child to the program were given a parental engagement questionnaire during the 10 min of free play that asked about how often they engaged in the take-home activities from the session before. The questionnaire had two sections: (1) FMS and (2) the SEL component. Each question asked about how often the parent/guardian practiced each activity with their child and is scored from 0 to 5 . Each week, the parents received a total engagement score , an engagement score for motor (average of the motor questions), and an engagement score for SEL (average of the SEL questions).Acceptability was defined as both the enjoyment of the program as well as the level of parental engagement (attendance and participation in the take-home activities). Enjoyment was chosen as a measure of acceptability because it is a common feature in most behavior change theories as a key indicator of sustained engagement . The chiFMS were measured using the Peabody Developmental Motor Scale 2nd Edition . The PDAs recommended by Denham et al. , a batteThe Social Skills Improvement System Rating Scales  was useThe Affective Knowledge Test (AKT) was used to assess emotion knowledge. The AKT was specifically designed for preschool-aged children and uses printed faces as well as puppets in order to assess receptive knowledge, expressive knowledge, and situation knowledge . To measUpon obtaining ethics approval, participants were recruited from families who attend local EarlyOn centers and preschools as well as those who attend Junior Blues programming. The participants were recruited using study flyers and recruitment material circulated via e-mail. Upon receiving a call/e-mail from interested families, the study information was e-mailed to the interested families. One week following, a follow-up call was made to determine eligibility, review the study information, and obtain verbal consent. Written consent was obtained at the first research appointment.All participants completed a baseline appointment at the INCH Lab at the University of Toronto. At this study appointment, the parents/guardians were asked to complete the demographic questionnaire and the SSiS-RS, which took approximately 20 min. While the parents/guardians completed the questionnaires, the children completed the AKT and the PDMS-2 with a trained graduate student who had extensive experience administering standardized tests, including the PDMS-2 to preschool-aged children. After completion of all baseline appointments, the intervention was conducted over 10 consecutive weeks and all study participants attended the sessions with a parent or guardian. Additionally, an at-home component was introduced, where the parents and guardians were encouraged to complete target skill activities outside of the weekly sessions. Following the completion of the intervention, all the participants were asked to complete a follow-up appointment including the same assessments from the baseline appointment. All the participants completed their study appointments within 2 weeks from the start and end of the intervention. The study appointments took approximately 1 h to complete (10–15 min for the AKT and 30–45 min for the PDMS-2). In order to mitigate confirmation and performance bias, the intervention leaders were not involved in administering the assessments at baseline and post-intervention. The assessor was blinded to the performance of the child during the intervention sessions.Move 2 Smile program and any feedback they may have. An interview guide was used to conduct the focus group and included questions pertaining to the acceptability of the intervention as well as changes in the physical and psychosocial domains that the parents observed , medium (dz = 0.5), and large (dz = 0.8). All data were analyzed using SPSS Statistics version 21. For all analyses, significance was set at a two-tailed alpha value of 0.05.The demographic characteristics were reported as means and standard deviations (SD). The median and interquartile range (IQR) were reported for the measures of acceptability and feasibility as these data were skewed. Descriptive statistics were computed on the ratings of each session as well as on the program ratings as a whole. These were further broken down into the two components of the program, FMS and SEL. Paired sample ect size . Cohen'se scores . Based oe scores , the effThe focus group was audio recorded and transcribed verbatim. Thematic analysis was conducted to identify key themes and messages . All traM = 50.56, SD = 8.63). The demographic characteristics of the sample are shown in Eleven families, including one family with a set of identical twin boys, were eligible and provided consent to participate in the study. One consented participant was deemed ineligible after the pre-assessment based on an apparent cognitive delay. While this participant was included in the program, they were not included in the final analysis. The final sample included 11 children (four girls) ranging from 36 to 59 months (The median attendance of the children and parents was 8/10 sessions (IQR = 1). The session ratings by the children and parents can be found in t-test analyses measuring the changes from pre- to post-intervention across FMS and SEL can be found in dz = 0.79) and emotion knowledge (dz = 0.58) and a small to medium effect size for both emotion regulation (dz = 0.44) and FMS (dz = 0.42).The results from the paired sample The results from the focus group were sorted into 39 different codes. Those 39 codes were sorted into five themes, which are presented in Move 2 Smile program. The parents agreed that the activities for both SEL and FMS were useful and applicable in everyday life. For example, speaking about the SEL activities, one parent stated that:With regard to the enjoyment and feasibility of the program, two key themes were derived from speaking with parents: (1) an overall positive experience and (2) concerns regarding the structure of the program. An overarching theme throughout the entire focus group was that parents (and children) had an overall positive experience participating in the “[…] the belly breathing and zones of regulation for him was just huge. Like really, really helpful. And we use that with him at home and like he does it and it seems to work and be really effective.” Tara, the mother of Cassie, commented on the SEL activities, saying that, “through the program, you know, you kind of gave me a bit of a toolbox to work with in terms of pulling certain concepts like the zones of regulation.” Feedback was equally as positive for the usefulness of the FMS activities, Mark's (Tom's father) first thoughts about the program were, “I mean, overall I thought the, all the movement stuff was great, the ball throwing and the jumping and the balance stuff, it's all good stuff to go through, yeah.” In addition to the positive thoughts around the actual programming, the parents often mentioned the positive learning environment as one of the highlights of the program, for example:“[…]the instructors made her feel comfortable right off the bat […] It was just like, so I think that came from feeling welcomed and supported because she wasn't like attached to me the whole time, so that was good.” Tara further commented:“And I also really liked how all of the volunteers praised the kids for their effort as well, not for […] achieving […] the goal or whatever it was that you set out to do. But just even acknowledging the effort was fantastic.” It was evident that the instructors were a big part of the success of the program, and this highlights the importance of training for the instructors for future programs. As well, the mastery climate set by the program instructors appeared to be a key contributor to the success of the program. Paul summed it up nicely, saying,“You can have the best programming in the world but like if you don't have like you know, really warm, like friendly people running it doesn't matter. But I thought like [the instructor] and the whole team were just really, really warm and friendly and welcoming and made everybody feel really comfortable.”All the parents said that the children really enjoyed the program and they were sad that the program was over. Maureen said that, at the end of the program, her child, Kelsey, said, “Why can't I do it again, is there some more?”A second key theme that came up when speaking about the quality of the program was its structure and the sessions themselves. The parents agreed that the SEL activities were too short, they seemed rushed, and that they would have liked to see more time spent on the activities. Maureen noted, “I felt that like there was maybe a little bit too much programming in that hour.” Sandra (mother of Alex) said, “But, yeah, the, I would say the emotions were, they were usually rushed.” Tara added:“I would agree, I mean, I think you were really fighting against a lot of time constraints […] So by the end of it the social-emotional skills component did feel really, really, condensed […].” It was agreed upon that an extra 10–15 min added onto the session would be optimal according to the parents in order to allow more time for SEL activities. The parents disagreed about the free play portion of the program whereby some parents liked it and said that it provided a sort of “respite” between the FMS and SEL activities:“[…] I kind of liked the free play because it offered a bit of an intermission or a respite between the two skill sets. So I think at least for my kid I think she really kind of appreciated that bit of a pause in the programming to let her do something relatively unstructured.” Some also liked that the free play mimicked what a school day would look like and helped prepare the child for what is to come:“[…] once your kid starts school and stuff there's going to be recess and like similar, the equivalent sorts of things in their broader day schedule where there's a break and it's unstructured play… John didn't always like the free play, he wanted to be able to see me and stuff. But it's good for him to, I think I want him to work on just going, playing by himself.” On the contrary, other parents did not like free play and did not seem to understand why the free play was included in the program:“And I understand the point of the free play was for us to sort of kind of just fill out our forms and questionnaires. But I, like Kelsey did not enjoy that. I think for my child, she needs structure, she needs focus and structure.” The parents had a few minor suggestions as to changes to the structure of the program that would have made the program better and more effective for them. However, overall, the parents were very pleased with the program and enjoyed their time in it.The practicality of the take-home activities was a third theme that arose in the parent focus group. While most parents agreed that the take-home activities were a nice addition to the program, it was evident that the handouts were not entirely feasible to implement at home. For example, one parent indicated that the paper handouts were not optimal:“[…] I think there's too much paper and paper gets shoved places, like it just always does. If you ask me to find my papers from the program I wouldn't be able to.” Other parents agreed with this; for example, Tom's dad Mark said, “Yeah. I think it's that reminder thing because, honestly, once you leave on Saturday it's kind of gone.” and “…So a reminder during the week is, would be a great thing, yeah.” In addition to the impracticality of the paper handouts, some parents also expressed that they would have liked to have more physical aids for the movement activities similar to what they had for the SEL activities:“But like the materials were usually focused on the emotion stuff. If there had been a material focused on the physical stuff […]. I think that would have helped me with the carryover.” The lack of physical aids may have been a reason for the lower levels of participation in the FMS take-home activities compared to the SEL activities. Overall, the feedback regarding the take-home activities not being entirely feasible is reflected in the low weekly engagement.Two important themes derived from the analysis of the focus group with parents were the positive impacts the program had on both FMS/PA and SEL. The parents were in agreement that the program was beneficial for developing FMS in the children, but also that they noticed changes in the interest and participation in active games. For example, one parent shared her observations of her child as a result of the program:“I think overall the program for her was hugely beneficial. I did see incremental change every single week and by the end of it she was a little bit more gregarious, a little less cautious, a little bit more participatory […] I think she enjoyed it so much that she started to develop her own games that she's playing with us as well. So a lot of ball rolling, catching.” Another parent shared,“[…] in terms of improvement I find she's really interested in balancing. She's always like, ‘Look at me on one foot, look at me on the other foot, look at me on the scooter, my foot is in the air.’ […] Well, she, we do the catching a lot more, like throwing balls cause like we just never thought that she'd be into it but she, from the program, that's an aspect.” It was evident that, according to the parents, the children became more interested in playing games and practicing FMS as a result of the program. In addition, the parents indicated that the children seemed more confident in their FMS following completion of the program.With regard to SEL, the parents also noticed changes: “Socio-emotional for John was just huge. And that was one of the main reasons that we signed up, we were attracted to this program.” (Paul). One skill, in particular, that was mentioned was the ability to recognize and express emotions; one parent shared that“[…] I think I found the, both kids actually now can like say something about their feeling, even in [family's first language], even in English. So, like, for example, ‘Mommy, I'm going to be sad when you say something like that’ or something. Like they can understand what they are feeling right now.” Another social–emotional skill that was brought up a lot in the focus group was the child's improvements in emotion regulation.“And it was similarly in the middle of a tantrum that Cassie was having it was only when I said, ‘You are in the red zone right now, let's try and get back to the green zone’ that she started to kind of really, you know, calm down. It was, yeah, it was useful, very useful.” Another parent agreed and shared a similar experience:“A while back John did something like, you know, broke something or whatever and then Tina was like, my wife's name is Tina, she said, ‘John, I'm really upset that you broke that.’ And he said, ‘Oh, mommy are you in the red zone?’ And he went through the whole thing. And then she said something like, ‘Yeah, I am.’ ‘What can I do to get you back in the green zone?’, he did the whole thing. ‘Maybe we should do some deep breathing.’ Like he said exactly the process that we said with him, yeah.” Move 2 Smile into the home:In addition to the changes in SEL parents saw in their children, they also highlighted the changes in themselves with respect to teaching SEL at home. Multiple parents shared the ways by which they have been able to apply SEL teaching strategies learned in “Yeah, I would say it's sort of changed the way we read, I guess, like when we read I usually just would read them a book and he would ask me a few questions about the people. But now I'm more like, ‘What is that character feeling, like what would you feel if you were that character?’ like questions like that never occurred to me to ask after we read a story. So that helped.” Another parent shared how they applied SEL teaching strategies, saying that“So I think, you know, she's been able to pause. Like it, sometimes it's really quick, like she likes to hit me and we have this book called Hands Are Not For Hitting. So it's always good to go back to that […]. So I guess, yeah, that's how we apply it.” Overall, the parents expressed that they felt their child's FMS and SEL improved as a result of the program. In addition, they felt as though the program has changed the way they foster SEL and FMS development at home.Move 2 Smile intervention. Families attended the majority of the sessions, and the feedback collected after each session demonstrated that the children, parents, and instructors were all in agreement that the sessions were enjoyable. The results from the focus group further confirm the acceptability and feasibility of the program as the parents reiterated that the program was enjoyable and useful to their family.The primary objective of this study was to assess the acceptability and feasibility of a program that targets both FMS and SEL in children aged 3–4 years. The results provide strong support for both the acceptability and feasibility of the Move 2 Learn study  and to provide information about the importance of practicing both the FMS and SEL activities at home.It can be concluded, based on the high attendance rates (80%) and the positive session feedback from both the questionnaires and the focus group, that the program was highly acceptable to parents and children. Further, the instructor of the program rated the program as highly feasible to administer. This supports the feasibility of targeting two developmental domains together in one program during each session. This finding is positive given the important link between FMS and SEL established in the literature , 16. Howrn study , 18 wher 2 Learn , 18. OneMove 2 Smile intervention, this study also sought to examine the impact the intervention had on improving FMS and SEL. Overall, SEL had the most substantial improvements across the 10 weeks and the intervention had the largest effect on prosocial skills. In addition, parents' feedback in the focus group suggested a noticeable difference in social–emotional skills at home, such as regulating emotions. These results are in line with a similar intervention, Animal Fun, which is a motor-based intervention that also includes a SEL module for children 4–6 years old  scored higher following the intervention. An exception to this was that of three participants whose FMS decreased post-intervention. The aforementioned Animal Fun program primarily targeting FMS in young children did not elicit a significant change in motor skills immediately following the intervention (6 months), which aligns with the current study . However% scored  2 Learn . This want study . The higMove 2 Smile intervention. This study specifically sought out participant feedback regarding the delivery of the intervention and the specific activities included in the program, which is traditionally missing in extant literature. The ORBIT model recommends a small sample size for pilot studies in this phase  and the parents were not blinded to the purpose of the study , which leaves room for possible confirmation and detection bias by favoring more positive responses to the questionnaires following the study. The last limitation is regarding the measures administered to the child (PDMS-2 and AKT). Although both measures are deemed valid and reliable in preschool-aged children, behavioral issues may have impacted the results both in a positive and negative way. One child in particular was quite nervous at the pre-assessment and was evidently more comfortable at the post-assessment, and this could have contributed to the magnitude of positive change in FMS from pre- to post-intervention. Other children were less cooperative at the post-assessment, and this could have impacted their scores on the assessments. In addition to the behavioral issues, the AKT had a ceiling effect at 50 months, which may have contributed to the high baseline AKT scores and lack of significant change from pre- to post-intervention.The primary focus of this study was on assessing the feasibility and acceptability of the is phase ; howeverMove 2 Smile program is accepted by children and parents and is feasible to administer. Furthermore, the results demonstrate promising effect sizes for the changes in FMS and SEL. The results from this pilot study are encouraging and suggest that a multicomponent approach for a program like this can be beneficial; however, more work is needed. Firstly, this study warrants moving to the next phase of the ORBIT model, which is to conduct a larger, randomized pilot study using a control group to measure the true effects of the intervention. Before further testing, a few potential program modifications should be considered: (1) the session duration should increase to 70 min, allowing more time for SEL activities; (2) the SEL activities should include more peer-to-peer interaction; (3) the FMS activities should be delivered as intended for 30 min each session; and (4) alternative methods  should be explored to increase the feasibility and participation in the take-home activities.Despite these limitations, the results of this study demonstrate that the Move 2 Smile may provide an acceptable and feasible multicomponent program that could be implemented in communities to have a positive impact on FMS, SEL, and development more broadly.This study is the first to explore the acceptability, feasibility, and preliminary effects of a multicomponent intervention targeting FMS and SEL in children under the age of 5 years. The results demonstrated that it is possible to target multiple domains of development together in one program, during each session, in preschool-aged children. This study demonstrated that a multicomponent intervention was accepted by the parents and children and was feasible to administer. Moreover, the combined results of the pre- and post-intervention assessments and the parent focus group suggested that the intervention may be positively impacting two key components of PA, mental health and school readiness: FMS and SEL. Given the impact of these developmental domains on current issues such as poor mental health and physical inactivity, this intervention has the potential to target more complex health concerns. By continuing to develop this program, The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The studies involving human participants were reviewed and approved by University of Toronto Research Ethics Board. Written informed consent to participate in this study was provided by the participants' legal guardian/next of kin.MJ designed the study, coordinated recruitment and data collection, designed the social–emotional learning component of the intervention, co-lead the weekly implementation of the intervention, conducted the data analyses, and drafted the initial manuscript. CB assisted with the design of the study, data collection, data analysis, recruitment efforts, and revised and approved the final manuscript as submitted. EB designed the motor component of the intervention, assisted with data collection, and revised and approved the final manuscript as submitted. JC supervised the design and execution of all phases of the study and revised and approved the final manuscript as submitted. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


Time Together, on maternal self-efficacy, mother-infant bonding, and mood/anxiety for community-based mothers. This program centered on maternal voice, timing of interplay, and recognition of infant cues. A convergent parallel mixed-methods design included quantitative measures: the Karitane Parenting Confidence Scale, the Mother-Infant Bonding Scale, Edinburgh Postnatal Depression Scale and State & Trait Anxiety Inventory, and a sequential qualitative analysis to elaborate on the quantitative findings. Significant changes on the Karitane Parenting Confidence Scale were found. Qualitative analysis of the participant interviews and reflective diaries from the two weeks following the psycho-educational program confirmed that participation enhanced mothers’ ability to understand their infant, to soothe their infant when distressed, to play and to establish an effective bedtime routine. This feasibility study indicated that this is a promising approach to improve early mother-infant interaction and maternal self-efficacy.This study examined the effect of a brief psycho-educational program,  Building on Bandura’s personal efficacy theory ,2, parenSelf-efficacy has been a target for parental psycho-educational programs, which seek to modify parental behaviors at the beginning of a parent-infant relationship. Such programs may be administered individually but are more typically group-based interventions which use didactic teaching, group discussions, demonstrations, role-play, and modelling of different aspects of infant care and parenting. Meta-analyses demonstrated that PSE is significantly enhanced by universal preventive psycho-educational programs, concluding that “providing universal parent education interventions that focus on enhancing PSE may be protective against the detrimental effects of fatigue and psychological distress that parents may experience” .Psycho-educational programs have the potential to be most successful when they concentrate on a parent’s pre-existing capabilities and bring them to the fore. One specific capability that is universally present, and highly salient for the newborn, is a parent’s use of voice. It is well known that infants show strong preference for infant-directed speech, which is characterized by its musical features . When caTime Together’ [Time Together the therapist validates and expands the existing expressive and receptive communicative capacities of new parents. It is designed to help mothers reflect upon infant and caregiver behaviors through a discussion of how the voice can create, support and modulate interplay with their infant. In particular, the content of the Time Together program includes consideration for the role that the maternal voice can play in mutual regulation within the mother-infant dyad, and encourages mothers to become aware of their infant’s cues for interaction in order to create and maintain an optimal range of interaction with their infant. Moreover, vocal interplay and singing provide a context in which mothers become aware of their own capabilities. In a qualitative feasibility trial of the Time Together program [Contingent Singing has been translated into a parent psycho-educational protocol called ‘ogether’ . In Time program , mothersTime Together was initially developed for clinical contexts, primarily families in the NICU, the utility of this program for families in the community has yet to be explored. The development of services to support those at risk, or with less dramatic needs may serve as a preventative strategy to sustain or build capacity in parents. Specifically, new mothers often report depressive symptoms [Time Together could influence parental self-efficacy, infant-bonding and parental mood/anxiety.Although symptoms , anxietysymptoms  and feelsymptoms  in the pM = 34.8, SD = 4.3) and their infants between 2 and 14 weeks of age , both before and after participation in Time Together. The participants were recruited across two periods of one week each through Millfields Children’s Centre and a parent-infant event in East London  help parents to interpret their infant’s gestural, postural, facial and vocal behaviors as demonstrations of the infant’s availability for interplay, and (b) promote awareness of how to use their expressive capacities in response to their infant’s behaviors, and (c) promote the parent’s awareness and a value for their capacity to respond to their infant’s cues in supportive and interactive ways. The expected outcome was the promotion of parental self-efficacy in dyadic interaction The program was administered by a qualified music therapist who was suitably skilled in the Time Together program which required skillful support, tailored information about parental and infant expressive behaviors, acceptance for the current status of what each participant knew, understood and could do . The Time Together program, when they also participated in a semi-structured follow-up interview. Each participant was also provided with a daily diary in which to reflect upon how they were using knowledge gained from the program in their everyday interactions with their infants. Participants completed the four questionnaires at two time points: immediately before and then two weeks after the Eighteen mothers and infants had a mean age of 34.8 years and 9.6 weeks respectively. The majority of mothers had completed undergraduate education and were first-time parents (89%), and the majority were currently employed (61%). Four participants were unable to complete the post-program questionnaires and were therefore excluded from the quantitative analysis.Overall the assumptions of internal consistency were not violated in the majority of administered scales, besides the MIBS which displayed low internal consistency . A Shapiro–Wilks test indicated a normal distribution of the data for the STAI and KPCS, and a non-normal distribution for the EPDS and MIBS, warranting the use of non-parametric statistics for these tests. Full baseline data of descriptive statistics are provided in t-tests were performed on the normally distributed scales, while one-tailed Wilcoxon signed rank tests were performed on the scales for which assumptions of normality were not met. p = <0.004). Data was analyzed using Excel’s ‘Real Statistics’ package at group level. One-tailed As there was a significant effect for the KPCS see , the KPCSeventeen participants indicated new capacity under KPCS 5: “I understand what my baby is trying to tell me”. Within this category, the themes were as follows: (a) a clearer understanding of the experience for their baby—Eight participants specified they understood when “it’s too much” for their baby. Five participants suggested they were “more in tune with” their baby. Four participants noted they understood their baby more, with Participant 11 simply stating, “We understand each other better.” (b) The notion of timing was reported. Two participants specified they now know their baby’s early cues of distress, and four noted that they now realize their baby takes time to react to something new. Participant 8 realized that, “If I did something, and he didn’t do anything, I thought “that’s ok then, he’s fine with it”, but I realize now it’s more like he was still taking it in, he wasn’t sure yet” and at the other threshold when it’s “too much”, Participant 22 commented that it was valuable, “knowing when she is turning away, actually she is tired and she doesn’t need stimulation.” A distinction that “I understand him/her differently now” was made by a four participants, and Participant 12 reported, “My eyes are more open for what I’m doing, I’m noting more things at the moment, I can tell that I understand my baby a little bit more.” Further responses were grouped around the participants’ capacity to soothe and respond to their infant’s distress . Participant 6 commented, “I am now able to diffuse most crying bouts by launching into song!”. Eight participants reported they had been singing songs to successfully soothe their baby, but also using other vocalizations such as the small chant (“sh-sh-sh”), and consciously using the reassuring high-to-low intonation. Participant 15 noted that “sort of really going from high to low when she was distressed seemed to really calm her down… so that was really good”. She and her partner had begun to sing at stressful times such as getting the baby to sleep or at bath time, thereby creating a reliable strategy. Participants used the diaries to report songs they had tested and confirmed as successful. Four participants reported effective use of chant (using their voice to chant little repeated sounds), a specific item from the program. Participant 6 reported she was now able to use her voice in a manner provided by the program to diffuse a previously stressful situation:“There was always trigger moments, that he gets upset, like putting on his snowsuit. He got upset every single time and we’d leave the house in tears, and the neighbors would be looking out the windows at the woman with her baby crying again, and it always seemed like the baby was constantly crying. So I started singing to him when I put him in the snowsuit and that diffused it. It’s diffusing isn’t it… It kind of diffused the moment, and he’d start smiling so we’d leave the house not in tears, which was good.” A further cluster of responses were coded under KPCS 3, “I am confident about helping my baby to establish a good sleep routine”. Participant 20 explained, “In bedtime I now use my voice to over-ride her cries and to let her know that it is ok to relax while using a similar mantra and remaining calm and soothing”. Six participants explained that singing had quickly become part of a new ritual for putting their babies to sleep. Participant 12 said, “Straight away after the session I started singing to him, and now this is a part of my new routine. I use this to soothe him to sleep, and we have a ritual now, after you feed, I sing for him and soothe him, and he falls asleep because I sing.” Participant 16 revealed, “I feel I have gotten better at putting her to bed, calmly and gently and with singing, so that she stays calm and happy and soothes herself to sleep.”For KPCS 7 (I am confident about playing with my baby), participants reported they began to take the time to notice what their baby enjoys, and commented that their babies “love” their singing and talking. They describe their play-time as having “real conversations”, and Participant 8 smiled, “He already seems to be reacting well to this—smiling every time I sing a new part of a song he’s heard a few times.”The final cluster of responses was for KPCS 13 “I feel I am doing a good job as a mother”, participants demonstrated both new-found assurance and re-assurance in their capabilities. Five participants noted increased confidence as the primary message from the program, with Participant 9 noting, “I’m a lot more relaxed and less worried about whether I’m doing the right thing.” Three participants felt more able to help their baby. Another four participants felt more connected, and Participant 21 commented “just the fact that I know he is responding to me, makes me feel I’m increasing my sense of well-being, ‘cause I feel like I am doing a good job”.really communicating”, and a further four felt more confident in their interpretation of their baby’s efforts to communicate. Three participants did note that they were singing more but they felt this was aligned with their baby’s natural development anyway.Participants were also asked about their experience of the program and if they felt it had influenced their relationship with their baby. The strongest messages from the program content were new realizations about the time it takes for a baby to “process what you’re saying” (13 participants), and the idea that babies can look away when they’re over-stimulated (8 participants). The strongest new realizations about their own capability after the program were that they could sing to soothe or settle their baby (14 participants), and after the program they were more confident in reading cues (6 participants). When asked how Time together had influenced their behavior with their baby, eleven participants reported that they felt more connected to their baby. Participant 10 noted, “I’d say, I connect with her on a deeper level much more often”, arising from an earlier comment that she was now much more aware of the heightened moments of attunement that have been referred to as ‘Moments of Meeting’ . Six parTime Together on measures of self-efficacy (KPCS), infant bonding (MIBS), depression (EPDS), and anxiety (STAI) in new mothers in a community setting. Originally developed for clinical settings, Time Together aims to help parents reflect upon infant and caregiver behaviors through a discussion of how the ways in which they use their voice can create, support and modulate interplay with their baby. The program’s specific objectives were to provide mothers with tools to strategically achieve caregiver goals via the use of the voice.The aim of the present study was to evaluate the impact of Significant improvement was seen at the group level for maternal self-efficacy (KPCS), with a large effect size (0.69), which is notable in the context of such a brief psycho-educational program (90-min single session). Indeed, a meta-analysis carried out by Bakermans-Kranenburg and colleagues  reportedTime Together program would yield improvements on these measures in at-risk groups where baseline measures are more likely to be in the clinical or sub-clinical range. The other three measures did not change, due to floor effects resulting from low levels at baseline of depression and anxiety and an absence of issues relating to mother-infant bonding in this particular community sample. It remains an open question whether the Time Together did stimulate participants’ confidence in both understanding and responding to their baby’s cues. As a fundamental part of parenting confidence, noticing and interpreting their infant’s cues is a lynchpin to sensitive interaction. Participants described increased confidence, feeling less stressed and more connected to their baby. This provides a promising alignment with Spinelli’s findings [The deductive content analysis elicited themes which further emphasize the shift in participants’ confidence in reading and responding to their baby’s cues. As a brief program, findings  that intThe program provided an acceptable and practical experience from which the participants reported that the strongest messages were a new understanding of their baby’s behaviors, and a new sense of their own capacity to purposefully respond to their baby with their voice. The participants’ statements of confidence in responding, enticing and soothing their baby are indicative perhaps of Spinelli’s notion of empathy . While tWhile this small-scale trial provides promising results, further research is needed to test the effect of the program for a wider caregiver groups, including fathers, and other significant people in the baby’s life. As the program relies on the therapist to tailor the program during implementation, program fidelity trials are needed before larger scale research is warranted. Implications for practice remain more evident for infants who are likely to experience altered opportunities for interaction with attuned adults either through health or social risk in the infant or parent. Time Together program is that a one-time 90 min session can provide encouraging results in the key area of maternal self-efficacy. The program makes no attempt to seek out and deconstruct traits but rather remains pivotally focused on the existing capacities of parent, and supporting them to imagine their own do-able actions. This feasibility study demonstrated that a brief voice-centered psycho-educational program that emphasizes the pre-existing communicative capacities of new mothers, provides promising outcomes for improved maternal self-efficacy as a key component of early parenting. The contribution of the


BCR–ABL1 as a mechanism of possible clonal evolution in relapsed AML has rarely been reported. Here we report our experience with three patients who had emergent BCR–ABL1 fusion at relapse after FLT3 inhibitors–based therapies. The first patient was refractory to multiple lines of therapies, including FLT3 inhibitors–based therapy. Patients 2 and 3 showed some response to combined FLT3-inhibitor and BCR–ABL targeted therapy (gilteritinib and ponatinib). The availability of effective targeted therapies for BCR–ABL1 makes this an important aberration to proactively identify and possibly target at relapse post–FLT3-inhibitor therapies.Despite the promising result with FLT3 inhibitors in AML, the emergence of resistance poses a significant challenge, leading to a shorter response duration and inferior survival. This is frequently driven by on-target or parallel prosurvival mutations. The emergence of  FLT3 has improved the outcome of FLT3-mutated acute myeloid leukemia (AML) (FLT3 (on target resistance)  . Despiteia (AML) –5. Theseistance) , 3, 5 oristance) , 5. HereA 33-year-old woman was diagnosed with AML with a normal karyotype . She received 7 + 3 induction without a response and was reinduced with fludarabine and cytarabine (FLAG) with complete remission (CR), followed by four cycles of high-dose cytarabine (HiDAC) consolidation. She relapsed 5 months after the last consolidation and was referred to our institution following an unsuccessful salvage attempt with FLAG.FLT3–ITD , with no BCR–ABL1 fusion or NPM1, RAS, IDH1&2, or KIT mutations. The patient received azacitidine with sorafenib with marrow remission after four cycles and underwent allogeneic stem cell transplant (ASCT), but relapsed 60 days post-ASCT with 58% bone marrow blasts, normal karyotype, and FLT3–ITD . After achieving a short-term remission with idarubicin, cytarabine, and sorafenib combination, subsequent relapse bone marrow demonstrated t in 7/20 metaphases with a positive BCR–ABL1 fusion transcript (55%) and FLT3–ITD   . The patDNMT3A, RUNX1, and U2AF1 mutations on a myeloid NGS panel [no FLT3 ITD/tyrosine kinase domain (TKD) mutation] at diagnosis at a local institution. He received consecutive therapies with CPX-351, decitabine, and FLAG-IDA, without a response. Repeat bone marrow analysis revealed an emergent FLT3–ITD mutation . After receiving a single-agent gilteritinib salvage therapy for 2 months, he was referred to our institution with progressive disease. The initial bone marrow revealed 70% blasts, normal karyotype [no t detected], positive for BCR–ABL1 rearrangement (2.8% by FISH) and BCR–ABL1 fusion (1.92%), FLT-3 ITD , RUNX1, U2AF1, and KRAS (BCR–ABL1 fusion transcript (7.05%) posttreatment. After failing the next salvage therapy , the patient received CPX-351 plus venetoclax, ponatinib, and gilteritinib combination with a marrow remission (MLFS) (BCR–ABL1 fusion transcript 0.05%). ASCT was performed with a CR on day 30 post-ASCT . The patient died 8 months post-ASCT in CR because of infectious complications.A 47-year-old man was diagnosed with AML with [add (7) (q32)], and and KRAS  (7). TheFLT3–ITD mutation achieved CR with 7 + 3 plus midostaurin. She relapsed 2 months later with t , FLT3–ITD, ASXL1, and KMT2A . After failing mitoxantrone, etoposide, and cytarabine combination and then salvage with single-agent gilteritinib, the bone marrow revealed 50% blasts with BCR–ABL1 rearrangement (91% by FISH). Upon referral to our institution, repeat bone marrow biopsy showed 38% blasts, complex cytogenetics with t, BCR–ABL1 fusion transcript (63.9%), FLT3–ITD , RUNX1, WT1 (three distinct mutations) (BCR–ABL1 at a level of 76.19%) and later died because of infectious complications.A 53-year-old woman with AML, diploid karyotype, and tations) . On day FLT3 mutations has improved outcomes in AML. Acquisition/expansion of mutations drives secondary resistance to FLT3-inhibitor therapy. Activation of parallel signaling pathways, such as PI3K/AKT and RAS/MAPK, is an increasingly recognized mechanism of FLT3-inhibitor resistance  in 15 (36.6%) and newly detectable BCR/ABL1 fusions in 2 (5%) patients  , results in a BCR–ABL1 fusion gene, encoding a constitutively active oncogenic tyrosine kinase. The incidence of the Ph chromosome in de novo AML ranges from 0.5 to 3% . Patient 1 remained refractory to multiple conventional salvage chemotherapy plus FLT3-inhibitor regimens, possibly in some part due to BCR–ABL–mediated resistance to FLT3 inhibitor–based therapies. Ponatinib is a potent kinase inhibitor with pan-BCR–ABL1 inhibitor activity and strong FLT3-inhibitor activity. Smith et al.  of 42 patients acquired F691 gatekeeper mutations at relapse post–gilteritinib therapy , identification of h et al.  demonstr%, identiAll datasets generated in this study are included in the article/supplementary material.The studies involving human participants were reviewed and approved by the Institutional Review Board (IRB), MD Anderson Cancer Center (MDACC) IRB protocol DR09-0223 and PA12-0395. The patients/participants provided their written informed consent to participate in this study.ND, AA, and MY collected the data, conceived, designed, and wrote the manuscript. SL, KP, BT, and GT analyzed and reported the molecular and cytogenetics data. CD, GB, TK, NP, GI, MK, NS, and FR treated the patients, read, revised, and approved the final manuscript. All authors contributed to the article and approved the submitted version.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


Ananya program in Bihar implemented household and community-level interventions to improve reproductive, maternal, newborn and child health and nutrition (RMNCHN) in two phases: a first phase of intensive ancillary support to governmental implementation and innovation testing by non-government organisation (NGO) partners in eight focus districts (2012-2014), followed by a second phase of state-wide government-led implementation with techno-managerial assistance from NGOs (2014 onwards). This paper examines trends in RMNCHN indicators in the program’s implementation districts from 2012-2017.The Eight consecutive rounds of cross-sectional Community-based Household Surveys conducted by CARE India in 2012-2017 provided comparable data on a large number of indicators of frontline worker (FLW) performance, mothers’ behaviours, and facility-based care and outreach service delivery across the continuum of maternal and child care. Logistic regression, considering the complex survey design and sample weights generated by that design, was used to estimate trends using survey rounds 2-5 for the first phase in the eight focus districts and rounds 6-9 for the second phase in all 38 districts statewide, as well as the overall change from round 2-9 in focus districts. To aid in contextualising the results, indicators were also compared amongst the formerly focus and the non-focus districts at the beginning of the second phase.In the first phase, the levels of 34 out of 52 indicators increased significantly in the focus districts, including almost all indicators of FLW performance in antenatal and postnatal care, along with mother’s birth preparedness, some breastfeeding practices, and immunisations. Between the two phases, 33 of 52 indicators declined significantly. In the second phase, the formerly focus districts experienced a rise in the levels of 14 of 50 indicators and a decline in the levels of 14 other indicators. There was a rise in the levels of 22 out of 50 indicators in the non-focus districts in the second phase, with a decline in the levels of 13 other indicators.Improvements in indicators were conditional on implementation support to program activities at a level of intensity that was higher than what could be achieved at scale so far. Successes during the pilot phase of intensive support suggests that RMNCHN can be improved statewide in Bihar with sufficient investments in systems performance improvements.ClinicalTrials.gov number NCT02726230. Parivartan, led by Project Concern International (PCI), advanced community mobilisation via self-help SHGs, integrating health modules into traditional SHGs to empower women to change behaviour and advocate for better quality of local RMNCHN services [Successful large-scale implementation of effective health interventions is a persistent challenge facing governments and non-governmental stakeholders in global health . Major pservices ,10.This first phase of the program relied on intensive support to governmental implementation of initiatives in eight “focus” districts by the aforementioned non-governmental organizations – CARE India, BBC Media Action and PCI – from 2011 to 2013. The intention of phased implementation was to identify those interventions that were successful, and to support the GoB to scale those across the rest of the state. The second phase, from 2014 to present, involved a shift from intensive NGO support to the provision of techno-managerial support through the Bihar Technical Support Program (BTSP), emphasising and facilitating government ownership and actions for implementation. The aim of the second phase, then, was to increase coverage and service quality at scale through health system strengthening and performance management by removing bottlenecks, providing planning and policy technical support, and building capacity via increased data utilisation and focus on outcomes [The first phase was evaluated by two household surveys carried out by Mathematica, which are presented in detail elsewhere ,11,12. TAnanya program offers a rich opportunity to study the impact of different intensities of interventions, scale, and implementation approaches, which can help to guide future efforts in introducing and scaling-up maternal and child health interventions in similar settings. We therefore aimed in this paper to examine how trends in RMNCHN indicators in the focus districts differed between the pilot and scale-up phases of the program, how they were impacted during the transition to scale-up, and how they compared between the initial eight focus districts and the other 30 districts of Bihar (where implementation started two years later) during scale-up so far.The phased implementation of the We used data from the cross-sectional surveys collected by CARE India – referred to as the Community-based Household Surveys (CHS) – that spanned the full length of the program. There were nine survey rounds in 2012-2017. Round 1 was used as a pilot of the methodology and thus was not included in this analysis. However, because of this, program implementation had already commenced before the round 2 survey occurred, and thus, the first survey in the analysis may not represent a true baseline.Description of the survey design and sampling can be found in Rounds 6-9 were carried out during the second phase when program implementation had been scaled up to all 38 districts. A modified LQAS-like (LQAS+) methodology was used with a larger sample size aiming to obtain point estimates for each district with a precision of ±5%. These rounds also included mothers of children aged 12-23 months. The sample of mothers from each block was proportionate to the number of eligible women in the block, with a minimum of 19 women for each of the children’s age groups, yielding approximately 15 687 women per children’s age group per round.An interview questionnaire was used to collect data on sociodemographic characteristics with specific modules for indicators relevant to each age group. Respondents completed an informed consent prior to the interview. Quality control was implemented from round 2 onwards with mandated spot checks and back-checks of 15% of the data by independent field supervisors. A metadata-base digital quality control system that was capable of tracking individual data collection devices in real time was established in 2016. Fieldwork in each survey round took about 2-3 months. Rounds 2-5 interviews were conducted by block coordinators, who were also facilitators of interventions, with a range of 4-6 months in between rounds. Rounds 6-9 were conducted with a range of 11-16 months in between rounds [We assessed antenatal care (ANC), birth preparedness, delivery, postnatal care and breastfeeding indicators for children aged 0-2 months; and indicators of child nutrition/complementary feeding, child immunisation, and maternal use of contraception for children aged 9-11 months -4 block-level census data  for the Sociodemographic characteristics for the respondents were summarised with percentages for categorical variables and medians and inter-quartile ranges for continuous variables.We made the following comparisons. First, we examined linear trends in the indicators: 1) in the first (pilot) phase between 2012 and 2014 using rounds 2-5 for districts (n = 8) that were the focus of the first phase, and 2) in the second  phase between 2014 and 2017 using rounds 6-9, separately for the eight formerly focus districts and the 30 non-focus districts. Second, we compared indicator levels between round 5 and round 6 – the period of transition from the pilot phase to the scale-up phase – in the formerly focus districts. Third, we compared indicator levels at round 2 with the levels at round 9 in the formerly focus districts, to assess the net impact of the program over its full course to date. Fourth, we compared the indicator levels between the eight formerly focus districts and the 30 non-focus districts at round 6 – the beginning of the second phase – to contextualise subsequent trends in the second phase and factor any differences in the interpretation of those trends. For all of these comparisons, we used logistic regression models, taking into account the complex survey design and sample weights generated by that design, with the binary study indicators as the dependent variables. For analyses of linear trends, the independent variable was a time variable constructed by considering the start month of round 2 to be the baseline time with a value of 0. The time lapsed in years between baseline and the start month of each subsequent round was assigned to that round. The odds ratio for this time variable should therefore be interpreted as the relative change in odds of the indicator per year. For 2-round comparisons, round was a categorical variable. In an attempt to control for secular trends due to changing characteristics of the sample over time, models were adjusted for sociodemographic variables identified as potentially associated with RMNCHN: household size, combined religion-caste variable, mother’s age, mother’s literacy, number of children, gender of focal child, nuclear family, type of house, husband’s education, mother’s education and total household assets. We calculated an asset index as the total number of assets that the household had from among the list of assets asked in each round  controlling procedure by Benjamini and Hochberg  using SAAnanya program which was registered with ClinicalTrials.gov number NCT02726230.Permission for access and terms of CHS data use were agreed with CARE India through a data sharing agreement and approved by the Stanford University Institutional Review Board (protocol number 39719). This study is part of the kutcha  (46.0%) followed by semi-pucca (38.9%) where either the roof or the walls were made of pucca materials such as burnt bricks and stone. Most of the respondents were Hindu non-Scheduled Caste/Scheduled Tribe (60.1%). Patterns were similar in subsequent rounds except for declines in kutcha houses and increases in semi-pucca housing, mothers with secondary education and median number of assets. Respondents in focus districts and non-focus districts were similar except for higher proportions in the latter of Hindu Scheduled Castes, kutcha housing, and men and women with secondary education. Similar patterns were observed among mothers of children aged 9-11 months , with an upward trend in some of the indicators (14/50 in formerly focus districts and 22/50 in the non-focus districts) and a downward trend in others . Overall, nine indicators had levels that were higher at round 9 than at round 2 in the formerly focus districts, 12 indicators were unchanged, while the remaining 28 indicators had lower levels at round 9 than at round 2.Overall, we observed a rising trend in 34 out of 52 indicators in the first phase in the focus districts , this level increased (odds ratio (OR) = 1.5, 95% confidence interval (CI) = 1.4-1.7) as did those of almost all other indicators of FLW performance   or polio immunisation that could be confirmed by an immunisation card (47% and 33% respectively). Having an immunisation card increased during the first phase  as did up-to-date immunisations . Given the secular improvements noted in a number of indicators in the first phase of implementation through the Mathematica difference-in-difference analysis [Ananya such as changes to conditional cash transfer programs for facility deliveries and health worker strikes could not be quantified.We have employed a rigorous approach in our data analysis, recalculating sampling weights across rounds to enable comparison between the two phases of the program as well as overall for the program between rounds 2 and 9. We also adjusted for the full complement of key sociodemographic variables in our analyses in order to minimise the effects of economic and social changes unrelated to the analysis , it is lWe note some limitations of our analysis. Round 2, which we treated in our analysis as the baseline, was carried out after some interventions had already begun to be implemented, and therefore the levels we designated as initial values may not have been representative of pre-intervention levels. The data relied on maternal self-report for the majority of indicators. Finally, this analysis was meant to be a high-level overview of changes in RMNCHN indicators during the program and more detailed explorations are needed to understand the successes and failures of the large and complex catalytic efforts encompassed by the program.Ananya program has shown some promising results with the available public health workforce in Bihar, but those results seemed conditional on the intensity of implementation support. The required level of capacity did not appear to have been yet achieved by the public health system at scale over the period of time included in this analysis. Yet, the rising trends observed during the first phase of the program suggest that it is possible to improve RMNCHN in Bihar, if the right investments are made to sustain the type and intensity of support required across the various health system components.The


Eliminating violence against children is a prominent policy goal, codified in the Sustainable Development Goals, and parenting programs are one approach to preventing and reducing violence. However, we know relatively little about dissemination and scale-up of parenting programs, particularly in low- and middle-income countries (LMICs). The scale-up of two parenting programs, Parenting for Lifelong Health (PLH) for Young Children and PLH for Parents and Teens, developed under Creative Commons licensing and tested in randomized trials, provides a unique opportunity to study their dissemination in 25 LMICs.The Scale-Up of Parenting Evaluation Research (SUPER) study uses a range of methods to study the dissemination of these two programs. The study will examine (1) process and extent of dissemination and scale-up, (2) how the programs are implemented and factors associated with variation in implementation, (3) violence against children and family outcomes before and after program implementation, (4) barriers and facilitators to sustained program delivery, and (5) costs and resources needed for implementation.Primary data collection, focused on three case study projects, will include interviews and focus groups with program facilitators, coordinators, funders, and other stakeholders, and a summary of key organizational characteristics. Program reports and budgets will be reviewed as part of relevant contextual information. Secondary data analysis of routine data collected within ongoing implementation and existing research studies will explore family enrolment and attendance, as well as family reports of parenting practices, violence against children, child behavior, and child and caregiver wellbeing before and after program participation. We will also examine data on staff sociodemographic and professional background, and their competent adherence to the program, collected as part of staff training and certification.This project will be the first study of its kind to draw on multiple data sources and methods to examine the dissemination and scale-up of a parenting program across multiple LMIC contexts. While this study reports on the implementation of two specific parenting programs, we anticipate that our findings will be of relevance across the field of parenting, as well as other violence prevention and social programs. Contributions to the literatureWe describe a plan for learning from the widespread dissemination and scale-up of two parenting programs in a range of low- and middle-income country settings. Few previous studies have explored this scale of dissemination of a social program.The study will combine primary qualitative and organizational data, as well as secondary quantitative data collected by implementing agencies and other research teams.The results will provide insights into dissemination and implementation across the implementation stages identified in the Exploration, Preparation, Implementation and Sustainment framework.The United Nations Sustainable Development Goal 16 has set the aspiration to “end abuse, exploitation, trafficking and all forms of violence against and torture of children” (target 16.2). This is no small challenge: over a billion children each year experience some form of violence, with most of the burden in low- and middle-income countries (LMICs) –5. ParenThere is growing interest in the scale-up of parenting programs –12. ScalParenting for Lifelong Health (PLH) is an initiative led by individuals from the WHO, UNICEF, and the Universities of Bangor, Cape Town, Oxford, and Stellenbosch. It aims to develop, test, and scale-up parenting programs to reduce violence against children and improve child wellbeing in LMICs. Since starting work in 2012, PLH supported a suite of low-cost, Creative Commons-licensed parenting programs, including developing PLH for Young Children (2 to 9 years), and PLH for Parents and Teens (10 to 17 years). Both programs are group-based and can be supplemented with home visits. Group sessions normally take place in community venues, such as village halls. Initially tested in randomized controlled trials in South Africa with promising results –33, the These two programs have experienced rapid dissemination in over 25 LMICs in sub-Saharan Africa, Eastern Europe, Southeast Asia, and the Caribbean .Delivery has been led by non-governmental organizations working with varying numbers of families. For example, in South Sudan, delivery by Catholic Relief Services reached several hundred families in 2017–2018 , while PIn 2020, as part of the COVID-19 response, core program components were converted into tip sheets for families with an interagency collaboration including the WHO, UNICEF, UNODC, USAID, the Centers for Disease Control and Prevention, and the Global Partnership to End Violence Against Children, as well as NGOs . FocusinAdapting the programs to fit the local context and culture;Conducting an implementation readiness assessment;Providing materials and tools for implementation, monitoring, and evaluation;Training frontline service providers including program facilitators, coaches, trainers, and coordinators;Assessing and certifying personnel.Two non-profit organizations, Clowns Without Borders South Africa (CWBSA), and the Children’s Early Intervention Trust (CEIT) in Wales provide the main support in Africa and Europe, respectively. PLH uses a cascading dissemination model in which CWBSA and CEIT  transfePLH facilitators range from community volunteers to professional psychologists depending on the context. Facilitators deliver the program to families—caregivers only for PLH for Young Children, and caregivers and their teens for PLH for Parents and Teens—and receive ongoing supportive supervision during delivery. To ensure high-quality program delivery, facilitator certification is done via structured live or video observations and is a requirement to be eligible to be trained as a PLH coach; coaches  provide ongoing support to facilitators. Likewise, PLH coaches are assessed for certification, which is a requirement before being trained as a PLH trainer who is licensed to train facilitators and coaches.The global uptake of the PLH programs provides an unprecedented opportunity to explore questions of scale-up across multiple LMICs. As a blueprint for the Scale-Up of Parenting Evaluation Research (SUPER) study, this paper will (1) describe research questions and their rationale, (2) outline study structure and methods, and (3) discuss challenges and opportunities.The study will use the Exploration, Preparation, Implementation and Sustainment (EPIS) framework , 42. EPIThe SUPER study focuses on the following research questions.Dissemination of evidence-informed practices is at the heart of implementation research. It is important to understand how and why PLH has been taken up by funders and implementers since this will inform dissemination of similar programs in future and of the same programs in new settings . The disProgram fidelity and adaptation exist in constant tension . While sPrevious studies of parenting programs within routine delivery have examined family outcomes using various data sources. These include examining administrative data from social services in the USA , data coSince the two PLH programs have been implemented for only a few years, it is important to examine the prospects and challenges for sustainment, such as via integration into existing service structures . For exaAn essential first step to financial and resource sustainability is understanding the costs in practice and at scale. While it is possible to extrapolate from implementation with smaller numbers of families, costs at scale may differ . There mThis study will use a mixed-methods approach. The research questions, and corresponding implementation phases and data collection methods are outlined in Table All organizations implementing PLH for Young Children and PLH for Parents and Teens, as well as researchers of formal studies, will be invited to contribute to the study. To allow a more in-depth understanding of our research questions, we will examine three case studies in depth, selected based on variation along the following dimensions: (1) geographical region, (2) level of government involvement in delivery, and (3) number of families reached , 50. GivThe study has received ethical approval from the Universities of Oxford SPICUREC1a__20_015) and Cape Town (PSY2017-040). We have obtained country-level ethics clearance from 15 participating countries, and further, country-level ethics will be collected as the study recruits additional projects. We will seek agreement from each of the organizations involved in the project before approaching individuals within the organization. For primary data collection . This tool assesses the quality of coaching provided to facilitators based on either live observations or video recordings of coaching sessions, including an activity subscale on the discussion of highlights and challenges and similar items for process skills as in the PLH-FAT.Enrollment refers to the share of recruited caregivers (and adolescents in PLH for Parents and Teens) who attend at least one session. Attendance refers to the number of sessions, out of the total possible number, attended by an enrolled participant. For the PLH programs, an overall attendance rate is calculated by using both group sessions and home visits, as well as an additional group session rate. Enrollment and attendance data are collected using organizational recruitment lists and attendance registers.Program purveyors offer organizations implementing PLH a set of family outcome measurement tools. Organizations are encouraged to add these questionnaires to their monitoring and evaluation data collection if they already have a system in place for family data collection, for instance, on HIV risk factors in the context of sub-Saharan Africa. The measures recommended for PLH implementers focus on caregiver and child behaviors and wellbeing Table . The tooTo characterize the organizations delivering PLH programs, and explore any variation in uptake, implementation, and sustainment between them, we will distribute a short survey to these organizations to capture basic organizational characteristics, such as size and focus of activity.Researchers will review locally relevant policies, protocols, and progress reports to identify the context that affects PLH implementation. Information on the implementation process will be extracted from progress reports and other routine documents, such as the implementation readiness assessment, where available. Formal requests will be sent to participating organizations to obtain permission to review relevant documents.We aim to collect the program set-up and implementation costs from at least the case study countries to examine how much the delivery costs in different contexts. We will review program budgets and collect data directly from the organizations directly about resources involved, based on the Global Health Consortium and J-PAL guidance , 66, as Semi-structured interviews will be conducted with representatives of governments, funding agencies, implementing partners, program facilitators, coaches, and trainers. Interviews will be held in person or virtually following interview guides, aiming for approximately 4–8 interviews per implementation site or until saturation is reached.Focus group discussions of between 6 and 12 participants will be conducted with PLH program facilitators and supervisors. The number of focus groups per site will be determined by the scale of implementation and heterogeneity of the participants. An experienced moderator will lead the discussions following a discussion guide, assisted by notetakers.The qualitative data collection will focus on the projects selected as case studies, although it may also include additional sites. Interviews and focus groups will be conducted by experienced interviewers who either speak the same language as the participants or are assisted by an interpreter. Interviews and focus groups will be transcribed. The transcripts will be either written in or translated into English, the main language of analysis. Spot-checking will be done during the translation and transcription phases to ensure consistency and accuracy.In addition to interviews and focus groups, fieldnotes will be compiled through stakeholder meetings, such as community of practice meetings. In such meetings, participants involved in the implementation of the programs will be solicited to give an overview of PLH programs in their countries, discuss challenges, and deliberate on possible solutions.https://osf.io/v597r/).Since this is an overarching blueprint, we provide an overview of planned analyses approaches. Where possible, data collection tools, protocols, and detailed plans for specific analyses will be published separately and listed on the project’s Open Science Framework page (To address Research Questions 1 and 2 (examining the dissemination and implementation of PLH programs), we will examine the attendance rates and trends among participating families, as well as variation in enrollment, attendance, and program completion. We will also summarize and examine variation in facilitator and coach sociodemographic characteristics, key organizational characteristics, and the relationship of these characteristics to other implementation outcomes, such as facilitator and coach competent adherence to the program, using regression and structural equation models. We will conduct analyses to examine family behaviors and wellbeing before and after participation in the program to address Research Question 3 , using regression-based models. We will also examine variation in family outcomes based on baseline family characteristics and program implementation. We also plan to compare implementation and outcomes associated with different combinations of services as PLH is often delivered alongside other programs. For Research Question 5 (costs and resources), we will summarize the average program costs and their variation.Techniques such as hierarchical linear modeling and generalized estimating equations will be used to account for the nesting of data—for example, families within areas. Missing data will be addressed using methods such as full information maximum likelihood or multiple imputation , or otheWhere possible, the research team will support implementation teams to lead their own analyses and ensure that data collected in a specific country remains stored there, even if it is shared for additional analysis elsewhere. It is also important to acknowledge that any analysis of routinely collected data, even in relatively high-resource settings, poses challenges, such as with data quality, social desirability, and selection biases –72. In sThematic analysis  will be Reporting will follow the COREQ standards . SummariWhere possible, we will combine multiple data sources to answer research questions. For instance, to help answer Research Question 2 (implementation and adaptation of PLH programs), analysis will draw on the qualitative interviews with facilitators and coaches, and quantitative data on facilitator adherence. We will use the FRAME framework to examine program adaptations . AnalyseThis project will examine nested information about the community, implementing organizations, types of programs implemented, implementation staff, and the caregivers and children who participate in the PLH programs. The use of multiple data sources and methods is designed to support learning as violence prevention programs are tested, disseminated, and scaled-up. No previous study that we are aware of has collected and examined dissemination and scale-up of a parenting program across multiple LMIC contexts. While this study addresses two specific parenting programs, we anticipate that our findings will be of relevance across the field of parenting, as well as many types of social programming, including those focused on education and violence prevention.Additional file 1: TIDieR checklist.


Service gaps and the absence of a clear-cut care/symptom management pathway for people recently diagnosed with dementia and their family carepartners motivated LiveWell Dementia Specialists to implement a multi-service post diagnostic support program including three occupational therapy (OT) interventions. Program services include an education series on ‘Resilient Living with Dementia’, family coaching and topical education sessions, and OT services including Care of Persons with Dementia in their Environments (COPE), Skills2Care®, and Home Based Memory Rehabilitation. Program services promote adoption of adaptive strategies and action steps to increase carepartner capacity and enhance quality of life among people with dementia. Participants complete assessments at baseline, program completion, and 4- and/or 10-month follow-up. Carepartners show improvements in dementia knowledge  and preparedness for caregiving . Program elements and adaptations of COPE for real world practice are discussed.


Because many sex trafficking survivors are incarcerated for crimes related to their exploitation, specialty, human trafficking courts were developed to offer resources and assistance to labor and sex trafficking survivors. This study assessed justice-involved youth participating in a specialty, anti-trafficking court program. The purpose of this study was to investigate justice-related outcomes of participants in a specialty court program. We examined: (1) the relationship between age at first citation and justice characteristics ; and (2) the number of months between first citation and enrollment into the program with the aforementioned justice characteristics. We used negative binomial models to estimate the relationships between age at first citation, number of months between first citation and program enrollment, with the four justice characteristics (Adjusted models showed that younger age at first citation was associated with significantly more bench warrants and citations while in the program. Likewise, fewer months between first citation and program entry was related to more bench warrants and citations.There is a need to evaluate the appropriateness of specialty, trafficking court programs in reducing continued justice involvement and these programs ability to meet the evolving needs of sex trafficking survivors over time. We recommend universal screening for trafficking indicators for all systems-involved youth and relocating trafficking specialty courts out of juvenile courts to dependency courts. It is estimated that between 4500 to 21,000 adolescents and young adults are involved in the sex trade each year in the United States , since sex trafficked youth often come into contact with law enforcement, another approach is taking no intervention action on the part of law enforcement. Petrosino and colleagues suggests that youth exhibiting delinquent behaviors, may be best left alone, allowing for the behaviors to desist with time and maturity  for prostitution. Safe Harbor policies were enacted to address this conflict in the law. Safe Harbor policies are state-level legislations that dissuade prosecution of children who are trafficked, provides victims protection from the exploiter(s), and seek to prosecute exploiters and abusers  and include demographic characteristics, mental health status, alcohol and substance use, child protective services history, and citation and detention history. Descriptive, bivariate, and multivariate analyses were performed to examine four justice characteristics measures—bench warrants, citations, running away, and placements. All participants were cis-gendered female and 74% were African American and 96% were US citizens. One participant went 72 months between first citation and program entry; we deleted this observation due to its status as an outlier. Two participants were missing information on abuse history and were excluded from analyses; analyses utilize information from 181 participants.Data for this study were extracted from juvenile case files for the program from 2012 to 2014 . Finally, running away is as unapproved leave from the youth’s residential home or from the court ordered placement.The key independent variables are age at first citation  and the number of months between first citation and entry into the court program. We calculated age at first citation by subtracting participants’ date of birth from the date of the first citation. We calculated months between first citation and court entry by subtracting the date of the first citation from the start date for the court program. We also included a measure for the length of time trafficking survivors participated in the court program—also captured in months—to reduce potential bias in estimating justice characteristics for participants that varied in time in the program. In order to increase confidence that relationships between key independent and dependent variables are not the result of prior risk behaviors, we incorporated a measure of participants’ justice characteristics prior to program entry corresponding to the dependent variable in each model . We also included a measure of abuse history that indicates whether participants experienced some form of abuse  prior to entry into the program. No history of abuse is the reference category.mean = 1.77; variance = 3.10), citations , placements , and number of times ran away . We utilized negative binomial models due to our four dependent variables being over dispersed count variables with no upper bound  provide a substantive and practical interpretation of findings. AMEs are the estimated differences after the other variables in the model have been controlled for . University Institutional Review Board approved this secondary data analysis from review.SD = 1.76), 1.75 citations (SD = 1.80), 1.94 placements (SD = 1.84), and ran away an average of 1.07 times (SD = 1.31). The average age at first citation was 15.18 years old (SD = 1.41), and approximately 15.26 months passed between receiving the first citation and entering the court program (SD = 14.09). Participants spent an average of 11 months in the program (SD = 7.38). Furthermore, there were some differences in justice characteristics prior to the youth entering the program. Participants received approximately 1.24 bench warrants (SD = 1.50), 3.20 citations (SD = 1.80), and 4.41 placements (SD = 4.41). Approximately 56% of participants ran away at least once prior to entering the program. Half of participants experienced some form of abuse. Ninety percent had abused substances, and 75% had at least one mental health condition.Table A correlation matrix between key measures is presented in Table IRR) with robust standard errors (SE), and average marginal effects (AME). For ease of interpretation, we include average marginal effects, which are interpreted as the predicted increase in the outcome based on a unit increase in the independent measure while other factors are held constant. Additionally, for parsimony, we focus on results for our two key variables of interest. The first model estimated the number of bench warrants issued while in the program. Results showed that a year increase in age at first citation was associated with .252 fewer bench warrants while in the court program, all other factors being held constant . A month increase between one’s first citation and entering the program was associated with a decrease in the number of bench warrants received by .039 . In other words, younger age at first citation and shorter time between first citation and program entry were associated with more bench warrants issued.Table IRR = .852, SE = .050; p < .01). Consistent with Model 1, younger participants tended to have worse justice outcomes while in the program. A month increase in the time between first citation and program entry was associated with a .025 decrease in the number of citations one received . The third model presents placements while in the court program. The statistically significant bivariate association shown in Table p < 0.05 level.Model 2 estimated the number of citations received while in the program. A year increase in age at first citation was associated with approximately .277 fewer citations while in the court program, controlling for covariates  for addressing commercial sexual exploitation of children. As reported, our findings indicate a need to move services designed to assist sex trafficking survivors out of the legal sector and lends support for decriminalization of prostitution among juveniles.