Internet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders.This study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe , for adolescents with anxiety concerns.This study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email support  to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety from baseline to 8 weeks (posttreatment), which was used to determine the sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis.d=0.3) between groups in a definitive trial. Data for calculating an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks.Of the 588 adolescents screened, 94 were eligible and enrolled in the study . Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female . Retention rates at 8 weeks were 28%  and 58% . Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents’ scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (Adolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point.ClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226. Anxiety disorders are the most prevalent of mental illnesses to be diagnosed before the age of 18 years. Approximately 1 in every 3 adolescents will meet criteria for an anxiety disorder in their lifetime .The current classification system for diagnosing anxiety disorders identifies several types: separation anxiety disorder, selective mutism, generalized anxiety disorder (GAD), social phobia, specific phobia, panic disorder, and agoraphobia . In geneCognitive behavioral therapy (CBT) is a well-established first-line treatment for anxiety disorders in adolescents ,7,8 and Although trained mental health professionals have traditionally delivered CBT, the structured, skill-based, and sequential nature of CBT translates well to computer-based delivery. A computer-based approach to CBT delivery can involve accessing a program via the internet , which typically involves therapeutic content being presented in web-based, structured modules in a progressive format. Technology-based features such as multimedia  and interactive user formats  may be used to deliver therapeutic content. In some ICBT programs, therapist support may also be included in the form of messages, phone calls, or in-person contact .d effect size=1.28), general anxiety (Beck Anxiety Inventory [d=1.47), and depression  [P<.001) and clinic-based, face-to-face delivery of CBT (P<.001); in contrast, those in a wait-list control condition displayed no significant change in severity [d=2.51). Most recently, Stjerneklar et al [P<.05), with the odds of being free of their primary disorder appearing 3.60 times greater for recipients of ICBT. Participation in ICBT was also associated with greater improvements in clinician-rated diagnostic severity (P<.05) and adolescent- and mother-rated improvement in anxiety symptoms (P=.001). Many positive effects of ICBT were maintained at the 3-month follow-up, including freedom from anxiety diagnoses and subjective improvement in symptomatology. At this time, broad recommendations for future research within the ICBT field include conducting power calculations to ensure adequate sample sizes, defining primary outcomes before conducting the study, presenting results from intention-to-treat analyses, and measuring and reporting treatment adherence [A total of four randomized controlled trials (RCTs) provide evidence of the treatment effects of ICBT for adolescents with anxiety disorders -14; two nventory , d=1.47)ng Scale , d=1.39)[d=1.39) . In anot[d=1.39)  reportedseverity . In a reseverity , a largedherence .We conducted a pilot RCT to inform the planning of a definitive RCT to test the effectiveness of the ICBT program, Breathe  compared with a static webpage listing anxiety resources . In the pilot RCT, we set out to (1) determine a sample size for the definitive RCT; (2) define a minimal clinically important difference (MCID), as defined by adolescents, for the primary outcome measure; (3) estimate recruitment and retention rates to determine the number of study sites needed and the timeline for recruitment; (4) measure intervention acceptability to inform critical intervention changes; (5) determine the use of cointerventions; and (6) conduct a cost-consequence analysis to inform a cost-effectiveness analysis for the definitive RCT.The study design was a two-arm pilot RCT (Breathe vs a static webpage) conducted with adolescents aged 13 to 17 years across Canada. We received approval from the Health Research Ethics Boards at the University of Alberta , Izaak Walton Killam Health Centre , and the Children’s Hospital of Eastern Ontario  to conduct the study. The study protocol was registered with ClinicalTrials.gov (NCT02059226) and published .soft launch with health care professionals providing study pamphlets to prospective participants seeking mental health care from emergency departments, mobile or school-based crisis teams, and primary care clinics in Edmonton, Alberta; Halifax, Nova Scotia; and Ottawa, Ontario. Cycle 2 spanned 12 months (September 2014 to September 2015) and involved the implementation of a communication strategy with health care providers and study site contacts. The communication strategy involved the distribution of study updates through email (using MailChimp) [We recruited adolescents between April 2014 and May 2016 over the course of 3 recruitment cycles. Near the end of each cycle, we reviewed the effect of the different recruitment strategies that we employed. Cycle 1 recruitment spanned April 2014 to August 2015 and involved a ilChimp)  on a monYouth eligible for participation were Canadian adolescents aged 13 to 17 years who (1) could read and write English, (2) had regular access to a telephone and a computer system with a high-speed internet service, (3) were able to use a computer to interact with web-based material, and (4) reported the presence of anxiety symptoms .The exclusion criterion was adolescent self-report of suicidal thoughts in the past week. In cycle 1 recruitment, we initially had a second exclusion criterion, receipt of face-to-face CBT; however, we removed this criterion midway in the first recruitment cycle (cycle 1) due to emails from adolescents who found it confusing . Upon reviewing the questions we asked adolescents about their participation in other services that would result in ineligibility, we inferred that adolescents were seeking the Breathe program as an adjunct to other counseling and school-based services (not necessarily CBT-based) and that this would likely reflect how the program would be used in a real-world setting. Although we originally implemented this criterion as a way of reducing the potential for cointervention during the definitive trial, removing it increased the extent to which the planned definitive trial would evaluate real-world treatment effectiveness. At the time of this protocol change, 150 adolescents had been deemed ineligible for study enrolment due to this criterion.We screened adolescents for study eligibility using a 2-stage process:Stage 1: During stage 1, we screened adolescents on inclusion criteria 1 to 3 and the second exclusion criterion until it was removed. Adolescents used a secure web-based process to answer questions to determine eligibility . TelephoStage 2: Adolescents who met the first set of criteria proceeded to stage 2 screening. Stage 2 screening was conducted via the secure, internet-based platform, Intelligent Research Intervention Software (IRIS) . During We screened adolescents for anxiety symptoms using the Screen for Child Anxiety-Related Emotional Disorders (SCARED) .To be eligible for study participation at this stage, SCARED scores needed to indicate the presence of anxiety symptoms. Adolescents were not excluded from study participation based on their SCARED scores. Although we originally thought that the Breathe program could be used by adolescents with mild-to-moderate anxiety symptoms , we did yes to any of the questions received a safety telephone call from a research team member who evaluated intent/severity/immediacy of risk before deciding on the adolescent’s safety and ability to participate. Adolescents who indicated an immediate risk of self-harm by responding yes to question 3 on the ASQ  were excluded from the trial and received brief telephone-based support from the research team member who encouraged the adolescent to seek mental health care appropriate to their level of need.We assessed the risk of deliberate self-harm using the 4-item Ask Suicide-Screening Questions (ASQ) . AdolescAdolescents aged 15 to 17 years were asked to consent to the study on their own behalf; adolescents aged 13 and 14 years were asked to assent to study participation. We also required parental consent for all adolescents aged 13 and 14 years, even if they were assessed as being able to consent. The intent was to have parents involved so that they could support their child with the enrolment process.Contact Us button that provided a pop-up email box with toll-free phone and email contact information for a member of the research team. The Contact Us button triggered a message to the participant that a research team member would contact them to answer any questions they may have before proceeding with consent/assent. Individuals were also given the option of saving or printing a blank copy of the informed consent form to read and review on their own instead of proceeding immediately to consent at that time. During the consent/assent process, individuals were guided through a series of sections describing what it meant to participate  and asking them to confirm  that they understood the study, its risks and benefits, and/or had any questions. True/False questions were added before the final consent/assent webpage to ensure that the individual understood the study information. If an individual answered incorrectly, a pop-up box with the correct answer and explanation appeared. The script was designed to give individuals ample time to make an informed decision about participation. Once consent/assent was indicated, the date and time of consent/assent were recorded by the myStudies website [Consent/assent from eligible adolescents was indicated electronically via the secure myStudies website . The fir website .Randomization took place after informed consent/assent was obtained. Adolescents were randomly assigned using a computer-generated allocation sequence with a 1:1 ratio to 1 of 2 groups. A graduate student trainee affiliated with the project generated this sequence and an email was sent to each participant with information on their assigned intervention and log-in/website information to begin participation. A permuted block randomization procedure  with ranin vivo activities); (6) contingency management (examining the function of anxiety from a reinforcement perspective) and modeling (viewing videos of others confronting feared situations); and (7) skills for maintenance and relapse prevention. An overview of module content is provided in Consistent with published treatment recommendations , the BreCheck-in, which asked the youth to assess and rate their social-emotional functioning over the past week . The program underwent an evaluation for usability with adolescents and clinicians before the start of the trial to improve the intervention’s technical interface, therapeutic messaging, and user experience  [Animations, embedded video, audio playback, graphic novel style vignettes, image maps, timed prompts, and on-screen pop-ups were used in each module to provide an interactive and multimodal experience. Each module included 4 components: ast week ; Discove scales) .tailoring content, which involved adolescents providing information for the program to use during the module  automated reminders—for example, adolescents were instructed at the beginning of the trial to use the program weekly and those who did not log in for 1 week received an email encouraging them to complete their weekly module.Breathe was delivered via IRIS, the same platform used for eligibility screening. The platform supports the integration of persuasive design  and enabe module ; (2) selAdolescents assigned to the control group received minimal intervention—access to a secure, password-protected static study webpage housed in IRIS. The website offered suggested anxiety-related trade publications, print-based workbooks for adolescents, and the names of national and local organizations and websites where the adolescent might find support. There was no interactivity or personalization included in the webpage. Adolescents assigned to the control group were provided with the option to access the Breathe program for clinical use at the end of their 8-week control group participation.Among those adolescents allocated to the Breathe program, a graduate student trainee monitored adolescent well-being under the supervision of a child and adolescent psychiatrist and the primary investigator. Adolescent well-being was monitored via adolescents’ answers in the check-in and check-out components of the program. Automated indicators built into the IRIS program flagged safety issues , and an email notification was sent to the trainee. The trainee would then (1) develop a plan of action and discuss it with the psychiatrist and principal investigator and (2) subsequently contact the adolescent and their parent(s) by phone follow-up within 36 hours. Serious adverse events were to be reported to the institutional ethics board. Among adolescents randomized to the control group, the website provided contact information for local emergency resources .Study participation did not begin until the adolescent logged into their assigned intervention via IRIS. Once logged in, participants could access either the Breathe website or the static webpage and could complete the study outcome measures. Outcome measures were available to complete at baseline , after the completion of module 8  or 8 weeks of website access , and at 3 months postintervention (follow-up).not/hardly ever true, somewhat/sometimes true, or very/often true.We used the SCARED  to screeA study log was used by a research coordinator to track the number of adolescents who were screened as eligible and were enrolled or not enrolled in the study as well as those who completed outcome measures at postintervention and 3-month follow-up.Self-reported age, gender, and province of residence, as well as adolescent and parent contact information , were collected from enrolled adolescents via IRIS before starting the intervention.We used the total score from the Multidimensional Anxiety Scale for Children–Second Edition  to measure anxiety symptoms pre- and postintervention. The MASC2 is one of the most widely used self-report measures in clinical trials in adolescents with anxiety disorders. It assesses physical symptoms, social anxiety, harm avoidance, separation/panic, and total anxiety, and has excellent 3-month test-retest reliability  and valiWe administered the MASC2 to adolescents in the experimental group at baseline and at each posttreatment time point. We used the data collected at the 3-month time point to estimate data completion rates for the full-scale trial. Adolescents in the control group completed the MASC2 at baseline and 8 weeks after study enrolment.a very great deal worse to +5=a very great deal better), a commonly used anchor [The MCID was defined using data collected from adolescents allocated to the experimental group following module 8 completion (posttreatment). Adolescents were asked to indicate the minimum change in anxiety for which they would consider it worthwhile to participate in the Breathe program. We used adolescents’ self-reported global ratings of change on a 10-point Likert scale  was used. We originally intended to use a 5-point scale but removed a neutral option on the scale to improve the interpretability of adolescents’ ratings. Scores ranged from 10 to 40, with higher scores indicating higher acceptability. Of the remaining 6 questions, one asked adolescents to identify topics they would like to see in future Breathe programs by selecting from a list of options . Two questions allowed adolescents to identify the top 3 most motivating program features and 3 most helpful modules from provided lists. Three questions were open-ended, allowing adolescents to note challenges or barriers that they faced in taking part in the trial, the extent to which they used the skills learned, and any technical issues encountered while completing the program.Adolescents allocated to the Breathe program answered 16 questions on program acceptability after completing module 8. An instrument was designed specifically for this study to assess ease of program use, sense of privacy, and delivery format and content. The research team reviewed the instrument for face and content validity. For 10 questions, a 4-point Likert scale  during completion of the program. This information was collected following module 8 completion. We also detailed software development and maintenance costs (for Breathe program maintenance and delivery) and any training and personnel costs associated with the Breathe program.The primary outcome was self-reported change in anxiety symptoms from baseline to 8 weeks posttreatment. Given the purpose of this pilot trial, primary outcome data were not used to estimate treatment effects. Rather, the outcome data were described and used to inform the sample size needed for a definitive trial. Secondary outcomes were study recruitment and retention rates, MCID, program acceptability, and health care resource use during the trial.The sample size calculation for the pilot RCT was based on obtaining data to determine the sample size necessary for a definitive RCT ,39. We st test power analysis was conducted for the change in score from baseline to postintervention to calculate the sample required per group in a definitive RCT [d=0.3) of the intervention on our primary outcome for the experimental group in the definitive RCT. We used the software R for the sample calculation .For each group, we calculated the mean difference in raw MASC2 scores (and SDs) from baseline to 8 weeks (postintervention). Per protocol, we used data from adolescents who had completed the MASC2 both pre- and postintervention for this analysis. A two-sided two-sample tive RCT . Given ttive RCT , we wereunknown if no answer was recorded. We used SPSS version 24 for all secondary analyses [We used descriptive statistics  to summarize demographic characteristics, recruitment and retention rates, health care utilization, and program acceptability. Participant data were considered analyses .We defined the recruitment rate as the number of adolescents enrolled during the study period divided by the number of adolescents eligible to participate during the study period. The recruitment rate was iteratively calculated throughout the trial to assess the adequacy of the recruitment strategy and formally determined at 26 months (the conclusion of the study recruitment/enrolment period) to determine an overall timeline for the definitive trial. Retention rates were defined as the number of adolescents who completed outcome measures at the 8-week (posttreatment retention) and 3-month (follow-up) time points divided by the number of adolescents enrolled. We used the 8-week retention rate to adjust the sample size for the definitive trial .We intended to use adolescent global ratings of change  reported at the end of Breathe program completion to estimate the MCID value . Howevert tests for continuous data and chi-square tests of independence for categorical data. A P value less than .05 was considered to be statistically significant.Analysis of program acceptability data included summarizing the number of modules completed, and examining whether there were differences  between program completers (>75% of modules) and noncompleters to identify potential confounders that would need to be adjusted for in the definitive RCT. We summarized responses to the satisfaction instrument using mean and frequencies and collated answers to open-ended questions. Completers and noncompleters were compared using two-sided two-sample We intended for health care resource use data to inform a preliminary cost-consequence analysis ,44. HoweRecruitment commenced in April 2014 and continued until the end of May 2016 for a 26-month recruitment period. During this time, 588 adolescents were screened for study eligibility. A total of 94 adolescents were confirmed eligible for study participation ; all consented and were enrolled in the study. The success rates of the 3 recruitment cycles are presented in The flow of participants through the trial is shown in Participant characteristics are shown in t test for means. The pilot data suggest that the pooled SD could be 15.7, translating the effect size of 0.3 to a detectable difference of 4.7 in change scores between the Breathe group and the control group.A total of 38 participants completed the MASC2 measure at both the baseline and the 8-week posttreatment time points (13/36 in the Breathe intervention group and 25/34 in the control group). Among adolescents in the experimental group, the mean change in raw MASC2 scores from 8-weeks posttreatment to baseline was −7.9 (SD 15.7). The 80% CI for the SD generated for the 8-weeks posttreatment to baseline change score was 12.6 to 21.7. For the control group, the mean change in MASC2 scores from 8-weeks posttreatment to baseline was −9.0 (SD 15.4). The 80% CI for the SD generated for the 8-weeks posttreatment to baseline change score was 13.1 to 19.1. Assuming 80% power and 5% type I error rate, 177 adolescents per group  will be able to detect an effect size of 0.3 using a two-sided two-sample somewhat better change and 7 reported a much better change.Of the 13 adolescents who rated their change in anxiety symptoms after completing the Breathe program, 6 reported a P=.32, .93, .49, and .49), the manner in which they learned about the study , age (P=.85), or baseline MASC2 T scores (P=.44). Completers and noncompleters could not be compared on self-identified gender due to the limited number of males enrolled in the study.Of the 36 adolescents who received the Breathe program, 13 (36%) completed all 8 modules  and 2  of adolescents provided feedback on the Breathe program . The meaIn terms of costs to develop the Breathe program, software development totaled Can $51,405 , whereas personnel costs associated with program development and maintenance during the study  totaled Can $73,172 .With regard to health care resource use outside Breathe, 39% (14/36) of adolescents in the study answered questions about health care resource use during the Breathe program. We summarize the findings from these adolescents, but acknowledge that the results may not reflect all adolescents allocated to the Breathe program. Counsellors  were the most commonly used resources; 50% (7/14) respondents reported having seen a counselor for anxiety at least once during their participation in Breathe, with 5 having attended 5 or fewer visits and 2 having attended 9 or more. A total of 43% (6/14) respondents had visited family physicians for anxiety-related concerns, although these visits occurred only once for all but one of this group. Other resources were accessed relatively infrequently, with the exception of 1 adolescent who accessed social work 7 times over the course of Breathe . During This RCT piloted procedures and obtained data on acceptability to determine feasibility for a definitive RCT that would test the effectiveness of an ICBT program for adolescent anxiety. The 3 key lessons learned from conducting the pilot study and being applied to plan for the definitive trial are as follows: (1) adolescents did not use all the Breathe resources provided, and adjustments to the program were necessary to increase program completion in the definitive trial; (2) recruitment by social media was the most successful modality for recruiting adolescents into the study and should be the primary recruitment strategy in the definitive trial to ensure timely study completion; and (3) protocol adjustments are necessary to increase study retention at each measurement time point to improve outcome data collection.Several adjustments were made to the Breathe program in an effort to support adolescents’ abilities to navigate and complete the program. First, we streamlined content and reduced the number of modules from 8 to 6. This decision was based on our observation of a leveling off of completion around sessions 5 to 6. To achieve this reduction, the flow of Breathe content was streamlined and focused, and content considered unessential or potentially overwhelming was removed . We also increased the use of video content in the 6 modules as this mode was described as inspiring by adolescents and created new first-person narrative videos to reinforce concepts and support adolescents in relating topics to their own lives. Second, we noted that participant feedback pointed to Breathe’s exposure component as a significant barrier to successful program completion. Although exposure is widely viewed as one of the most important components of therapy in terms of producing lasting change in anxiety symptoms, it does produce discomfort and may have contributed to the lower retention rate in the Breathe group as compared with the control intervention. We made 2 changes to exposure activities in the Breathe program. First, we adjusted the flow of our content so that exposures were first introduced in module 2 ; with this change, the concept could be introduced gradually and promote adolescents’ sense of positive change as a result of participating in the program. Second, we added telephone-based support from a coach to module 2. The coach will help the adolescent build an exposure activity plan tailored to their specific needs, clarify any confusion about how to set up an exposure activity, and address perceptions of self-efficacy in completing exposure activities. A recent systematic review suggests that this type of ICBT support  may boost ICBT adherence and engagement, particularly when delivered at critical points in a program that participants may find difficult or taxing .In this pilot study, we enrolled 94 adolescents over a 26-month period (approximately 4 adolescents enrolled per month). This recruitment rate is not feasible for enrolling 354 adolescents (before attrition) in the definitive RCT. In testing different recruitment strategies, however, we learned that recruitment was most successful via social media . We were able to recruit approximately 4 times the number of adolescents in cycle 3 (n=75) once we launched our social media strategy, compared with cycles 1 and 2 during which we relied on health care providers. For the definitive trial, we plan to hire a communications specialist to assist with social media recruitment efforts. The communication specialist’s role will be governed by the following key objectives: (1) to create study awareness and inform the target audiences  about the Breathe program and study; (2) to increase traffic to the study website; and (3) to increase recruitment of study participants, including specifically targeting males. More broadly, our social media strategy will involve consideration of the functions of each communication strategy and any associated costs , development of study-branded, tailored content, including that geared toward males  to increase their recruitment; an established approach for social media use , and a strategy to enhance user privacy  and safety .To improve study retention in the definitive trial, we will budget for financial tokens of appreciation in an effort to increase the response rate to study questionnaires . We will also streamline the initial screening steps for consent and eligibility to reduce early dropout and will include those identifying as receiving CBT and other forms of treatment for anxiety. As other similar trials did not report such low retention rates nor offered incentives -11, we dAnother important aspect of this pilot trial was our intent to define an MCID for adolescent anxiety. However, challenges with retention did not permit us to calculate an MCID as planned. A critical aspect of all ICBT programs is the degree of improvement adolescent users experience as a result of their use. The use of MCID estimates could help adolescents, parents, and health care providers select among ICBT programs with different effects and anticipate the meaningfulness of the expected differences in their effects . Moving forward, within the broader literature, there is no minimum sample size necessary for calculating an MCID for a patient-reported outcome for adolescent anxiety. However, studies exploring the use of MCID scores in intervention-based research noted that this value has been calculated and used meaningfully in studies with sample sizes of a minimum of approximately 60 participants . Should The most significant limitation of this pilot RCT was the lack of data at posttreatment and 3-month follow-up. Unlike in the pilot, where posttreatment and 3-month follow-up MASCs were only administered if/when participants completed all program modules, administration of follow-up questionnaires in the definitive RCT will occur independently of program progress—ideally increasing the data available at both follow-up points and limiting the extent to which it is subject to selection bias. Another important limitation was our reliance on adolescents’ own recall when providing information about their utilization of other health care services. Addressing this limitation is challenging, given the privacy considerations and logistics that would be associated with verifying self-report data with information from other sources. However, as discussed previously, support from research staff will be made available to participants throughout their involvement in the full-scale trial, and they will be encouraged to contact staff with any questions that may arise as they provide this information.A final limitation was the exclusion of 150 adolescents early on in the trial due to their report of CBT participation. Although we do not know how many of these adolescents would have consented/assented to participate in Breathe, their exclusion introduces the potential for further selection bias in the study. In this study, initial recruitment in cycles 1 and 2 was also very slow until a social media component was included in cycle 3. That these changes occurred during the pilot study and not the definitive trial is important, and we do not anticipate needing to adjust this inclusion/exclusion criterion or the recruitment modality utilizing social media further. In the definitive trial, efforts will also be focused on increasing the number of male participants, which was a limitation to our pilot trial’s study population.This study aimed to determine the feasibility of a definitive RCT exploring the effectiveness of Breathe, an ICBT program for adolescents reporting anxiety, by piloting procedures and assessing intervention acceptability. Adolescents enrolled in Breathe reported modest satisfaction with the program, with most indicating that it had been easy to use and was readily understood. Still, adjustments to the program are required to reduce attrition and address the barriers that adolescents encounter when attempting to complete key program elements. These adjustments, including streamlining program access and content and providing phone coaching support for adolescents around challenging elements of the program, will ideally increase recruitment and retention within the study, thereby promoting timely completion of the Breathe program and supporting the completeness of our dataset at each outcome time point. Ultimately, with these adjustments, the definitive RCT will allow for a more in-depth exploration of the impact of the Breathe program on adolescents with anxiety and inform ICBT utilization within mental health care systems.


Mentoring is a critical component of career development and job satisfaction leading to a healthier workforce and more productive outputs. However, there are limited data on mentorship models in regional areas and in particular for women aspiring to leadership positions. Mentorship programs that leverage off experienced mentors from diverse disciplines have the potential to foster the transfer of knowledge and to positively influence job satisfaction and build capacity within the context of workforce shortage.This study describes a dual-mentorship model of professional development for women working in health in regional and rural Australia. We present the framework and describe the evaluation findings from a 12-month pilot program.Both academic and corporate mentors provided diverse perspectives to the mentees during the 12-month period. On average, corporate mentors met with mentees more often, and focused these discussions on strategy and leadership skills whilst academic mentors provided more technical advice regarding academic growth. Mentees reported an improvement in workplace interconnectedness and confidence at the completion of the program.We developed a framework for establishing a professional mentorship program that matches women working in regional health with mentors from diverse sectors including business, government, philanthropy and health, to provide a holistic approach to improving career satisfaction, institutional productivity and supporting a diverse workforce in regional or resource-poor settings. Despite the high overall health status of many Australians, rural and regional areas within this country continue to experience comparatively poor health outcomes . Health Literature shows that professional networks and formalized mentoring programs provide an opportunity to exchange knowledge, develop leadership skills and advance careers . MentorsIt is widely recognized that career advancement in medicine, research and health more broadly, remains in favor of men . Not onlWe sought to identify the needs of women working in the geographically isolated north of Australia and used these to inform the key elements of a new dual-mentor model, called the Catalyse Mentorship Program (“Program”) for women working in healthcare within a resource-poor setting.In 2018, a professional network called Women in Tropical Health (WITH) was established as part of a large health research program, ‘Improving Health Outcomes of Northern Australia’ (HOT North). In November 2018, a needs analysis survey was conducted to determine the requirement for a formalized mentoring program in regional and rural Australia , with 28% (n = 12) early career and 17% (n = 7) in established leadership roles. Despite 95% (n = 40) of survey participants requesting a formalized mentorship program, the majority did not have the opportunities to participate in one . The majority (88%) considered mentoring as a discussion about personal and professional goals whilst others thought it as an opportunity to be coached on a particular task. When asked “What main areas of development the participant would benefit from the most”, the two main themes that emerged were “clear career pathways” and “diverse perspectives”.There were 42 responses provided to the need’s assessment survey conducted in 2018 and prior to starting the pilot Program  were neutral, as was one academic mentor and no participants disagreed with the process of self-matching.n = 4) and females (83%) from a range of sectors including health, academia, transport, banking and insurance.The 12-month pilot included nine mentees from northern Australia and one international mentee, with one mentee not completing the pilot (90% completion). Each mentee was matched with two mentors, five of which were ‘dream’ mentors. A total of 18 mentors were recruited to the Program. The mentees represented a diverse group of health professional  at various levels of seniority. The mentors represented males  reported an increase in job satisfaction. One mentee reported an increase in their technical skills  to various measures of mentoring benefits during the pilot. Eighty percent of the mentees reported an increase in feeling of interpersonal connectedness in the workplace; and 62%  of the mentees rated achieving this goal as very well or well, whilst the remainder were either neutral or poorly achieved. All the corporate mentors and 83% academic mentors felt that their mentees had achieved the goals which were set in the beginning of the Program.At the completion of the Program, the evaluation questionnaire asked both mentees and mentors to reflect on how well the mentee achieved these goals. Only one third  “The wonderful support group that the participants created. I didn’t expect there would be so much laughter and jokes.”A new peer-to-peer support group initiated and led by one of the Program mentees. As quoted by a mentee (self-assessment during a workshop) to be a highlight of the Program “A new networking group established by a partnership from a Program mentee and corporate mentorA new feasibility study conducted in collaboration with a Program mentee and corporate mentor to improve health service delivery in regional Australia“Connection with the corporate mentor opened up opportunities I never would have explored by myself.”A business case to test the commercialization of a research Intellectual Property concept developed by Program mentee and corporate mentor for future career interests: Prestigious academic awards and accoladesPhilanthropic sponsorship to the Menzies School of Health Research from a Program corporate mentor, who had no connection to the organization prior to the Program.The Program resulted in several promising and notable outcomes that were not initially intended. A summary of these is listed belowmore inclined to meet people and make the first move”. This is further demonstrated through first-time activities undertaken by the mentees such as: business case development, establishment of peer-to-peer networking groups; application for (or nomination and receipt of) prestigious awards and accolades. For some, the Program has not had the same immediate affect “I’m not as clear about my next step as I would like to be. But that’s ok.” In this instance, it has provided these mentees a way forward through the “tools I learned about in this program.”We describe the successful pilot of the Catalyse Mentorship Program (the “Program”). A formal evaluation combined with self-reported surveys demonstrates that the Program resulted in the mentees experiencing positive ‘discomfort’, by being pushed out of their ‘comfort zones’ and requiring them to think differently. Many have changed their behaviors, as demonstrated by improving time management and priority-setting; and being “We found that within the regional context, relying on one style of mentoring (i.e. didactic or peer-peer support) may not be suitable. Traditional hierarchical mentoring with unidirectional mentor-mentee relationships have worked well in large research institutes and shown transformative mentorship for junior faculty in the short  and longNot all measures of a perceived successful mentorship program were achieved. We found a divergence in responses relating to achieving Specific, Measurable, Achievable, Relevant, Time-bound (SMART) goals set at the beginning of the Program. An explanation of this is likely multifactorial and may be a combination of recall bias  or differences in the interpretation of ‘achievement’ by mentees and mentors as it relates to goal progress . To moreThe dual mentorship model as evidenced in the Program, provides an outstanding example of corporate female leadership to a cohort of women who are likely missing out on such opportunities. In the Program pilot, only 50% of the academic mentors were women, whilst all the corporate mentors were female. This may be a factor of a lack of female representation in senior academia  and moreThe successful implementation of the Program does not automatically imply creating a mentorship culture but it’s a start. To leverage the gains from the Program pilot, mentees and mentors were asked if they would contribute in future programs and all agreed. Importantly, mentees expressed interest in participating in the next iteration of the Program in leadership roles, ranging from program facilitators, mentors or personal supporters. We believe that the Program has offered personal and professional opportunities to its participants to be both leaders and learners. It provides a framework for mentorship embedded into the institutional culture, which is suitable to the local context. We acknowledge that institutional support is a salient influencer of the success of formalized mentorship programs .Though workforce retention was not an initial aim of the Catalyse Mentorship Program, we believe that providing strong professional networks in regional Australia may prove to be one initiative, in addition to others –50, to aWe acknowledge several limitations in the present study. These include that the findings are from a pilot program with relatively low number of participants. It is a descriptive study which is not controlled and may therefore be subject to bias. This is mostly likely selection bias due to the selection of mentees from a small pool of healthcare professionals that may not be representative of the sector. Additionally, the formative evaluation collected data which required that mentees recal long periods of time (approximately 10–12 months) and their responses may therefore suffer from recall bias. We did not conduct in depth interviews as part of the formative evaluation and were therefore limited in gaining detailed insight of impact. Future evaluations of this Program and other similar programs should consider investing resources in conducting in depth interviews to assess meeting Program objectives and outcomes.Despite these limitations, the current study provides tangible measures of outcomes both for the health research sector and those wanting to develop mentoring programs within academic institutions and/ or resource-poor settings.This Program has shown promise in providing an interdisciplinary environment and professional networking to specifically deal with aspects of women’s career development, job satisfaction and regional workforce retention. In the future, designing programs that deliberately engage with the corporate sector; that actively support peer-peer mentoring, and offer distance mentoring  would be beneficial. In this cohort, 20% of the mentees were off-site and attended all workshops via video conferencing. Given the current travel and meeting restrictions due to COVID-19, we would envisage that virtual workshops and distance mentoring may be an effective conduit to maintain momentum and career progression during such challenging times.Additional file 1: Table S1. Needs assessment questionnaire. Table S2. Catalyse Mentorship Program Workshops 1–5. Table S3. Evaluation questionnaires for mentors. Table S4. Evaluation questionnaires for mentees.


This study aimed to identify and describe the various patterns of perspectives among older adults with mild cognitive impairment (MCI) living alone on participating in a dementia prevention program. Q methodology was applied to investigate the perspectives of 30 community-dwelling elderly people with MCI living alone from March to August 2018. As Q methodology applies a forced distribution through the Q-sorting technique, it could capture participants’ perspective patterns. Thirty-two Q-statements were constructed to explore the participants’ attitudes regarding their participation in a dementia prevention program. The participants performed Q-sorting to rank the 32 statements into a Q-sort grid. Principal component analysis was conducted using the PQ Method 2.35 software to identify patterns in participants’ perspectives. Four patterns of shared perspectives, accounting for 54.65% of the total variance, were identified: (a) awareness of health benefits and readiness to take preventive actions; (b) emphasis on cost consideration, and not ready to participate; (c) concern about family’s attitude and needing family support; (d) emphasis on medical care and needing providers’ recommendation. The exploration of clusters of the elderly with MCI could assist health professionals in acknowledging elderly people’s attitudes and responses towards participating in a dementia prevention program. With the development of medical technology and public health, the average human life expectancy has been extended. In Taiwan, the proportion of older adults over 65 years of age was over 14.56% in 2018 ,4. If elIn addition, one of the most common problems of community-dwelling elders living alone is a lack of interpersonal interaction. A previous study indicated that low social participation, less frequent social contact, and more loneliness were statistically significantly associated with the incidence of dementia . ElderlyAccording to statistics in Taiwan, mild cognitive impairment (MCI) is estimated to affect 18.16% of older adults over the age of 65, and 7.78% of the population is diagnosed with dementia . A previous review article of clinical trials indicated that non-pharmacologic interventions can delay the progression of functional impairment or disability among community-dwelling dementia patients . A UK prThe Taiwan government has promoted the long-term care 2.0 program since 2017, and dementia prevention and care is a critical service. The target population of the services is older adults with dementia or who are at high risk. The service aims to provide a dementia prevention program located in long-term facilities and community stations. The goal of the program is to maintain the physical, cognitive, and interpersonal functions of patients with MCI or dementia and effectively reduce the burden on family caregivers. For example, the program may consist of a series of training including computing skills, dance abilities, diet and nutrition skills, problem solving skills, and interpersonal interaction .concern) and the influence of the community (community) to become the 6C framework in the current study. The 6C framework in our study underscores the importance of participants’ needs, including (1) concern: emphasizing that participants will have increased interest in a health program because of their concerns; (2) consumer: meeting participants’ needs is more important than health program functions; (3) cost: participants are willing to pay to meet their own needs—e.g., monetary expenditure, time, physical and energy consumption, and risk-taking; (4) convenience: the marketing channel focuses on the convenience of participants when they intend to participate in a health program; (5) communication: a two-way communication between the program deliverer and participants needs to be emphasized to enhance mutual understanding and achieve a feasible marketable path; and (6) community: the influence of significant others on the participant [An effective dementia prevention program needs a successful marketing strategy to attract the targeted population. In the past, social marketing emphasizing the “4Ps”—product, place, price, and promotion—has been used in public health programs to achieve behavioral change . Howeverticipant . We usedQ methodology integrates qualitative and quantitative research methods by combining conceptual categorization with the quantification of participants’ patterned perspectives ,19, and Thus, the study aimed to identify and describe the various patterns of perspectives of elderly with mild cognitive impairment living alone on participating in a dementia prevention program. In order to develop Q-statements based on the 6C framework, the interview questions  were senThe study was conducted in a district of Taipei City, Taiwan, in 2018, where 41,622 elderly people were residing at the time. In total, 331 elderly people living alone were registered to receive health services from the district public health center. AD-8 was arranged as one of the health assessment for them. Among them, 62 elderly people who had MCI were eligible participants for this study. The prevalence rate close to that reported in previous studies . We visiThe inclusion criteria were as follows: (a) 70 years old or older; (b) able to communicate in Chinese and/or Taiwanese; (c) living alone; (d) AD-8 Dementia Screening Interview ≥2; (e) willing to participate in the study and signed the consent form. Finally, 30 older adults were included in the study. Webler, Danielson, and Tuler  proposedWe collected information about the participant demographics, including age, gender, marital status, education, and income level, using a questionnaire. The participants gained information on a dementia prevention program by reviewing a brief document that included existing literature suggesting a dementia prevention program . The proThe participants were invited to provide comments while selecting the statements that reflected their own perspectives on participating in a dementia prevention program. Their comments were recorded and extracted to support statements in the results section. The narrative descriptions were extracted from those comments to reveal examples of patterns of perspective.The study protocol was approved by the institutional review board of the National Taiwan Normal University  and all the participants provided written informed consent. The PQ Method software (Version 2.35) was used to analyze the collected data. Q-sort factor analysis rather than traditional item factor analysis was used to form participant groups (factors), based on similarities in their Q sorts. The major difference between the two types of factor analyses was that the Q-sort factor analysis clusters people instead of clustering question items. Factors were extracted using principal component analysis with Varimax rotation applied to maximize the similarities within factors and the differences between them. Rotation ensured that each participant was loaded on only one factor. The participants who loaded significantly on a factor had similar perspectives about participation in a dementia prevention program. The relative contribution of each factor in explaining the total variance in the data set was determined using eigenvalues. A combination of eigenvalues reflects the amount of variance accounted for by a corresponding factor. Four factors with eigenvalues greater than one were derived. The statistical analysis revealed that the four-factor solution was the best fit for the data. As shown in p < 0.05), they were also included to highlight the differences among the extracted factors. Through the statistical analyses, four factors were extracted that accounted for 54.65% of the total variance. The description of each factor is presented based on the ranked statements at both ends during the Q-sorting process . In addition, if the Q-statements ranked as +3 or −3 were distinguishing statements , increase knowledge , and increase physical activity , but they were concerned that their level of physical load would influence their participation in a dementia prevention program .Those who shared this perspective pattern revealed a similar perspective—for example, participants 08, 09, 10, and 27 provided comments such as “participating in multiple cognitive activities will promote health”, “be happy to recommend that neighbors participate in a dementia prevention program to improve health”, “would like to participate in cognitive activities hosted by the community”, and “I will do my best to participate in such a program to improve my health”, respectively. Participant 08 also claimed that he was undergoing rehabilitation treatment after a stroke attack, worrying that “if some of the program activities are strenuous, they are too challenging for me”, so physical load needs to be considered in relation to participation. Elders who shared this perspective pattern agreed that costs would influence their likelihood of participation in a dementia prevention program. According to the characterizing statements, cost considerations referred to the travel distance , the program fees , the total number of sessions , and the duration of each session . Those who shared this perspective pattern provided similar narratives. For example, participants 05 and 18 both stated that the location of a dementia prevention program should be “close to my residence or living community”. Participant 05 insisted that “the program should be free of charge, otherwise I would not participate in it”, while Participant 19 claimed that “I need to take care of my sick daughter, and cannot leave home for too long to participate in a dementia program”. Participant 25 suggested that “the total number of sections and the duration of each session should be short”. Elders who shared this perspective pattern emphasized family response as a key to participating in the program. They still keep in touch and interact with their families and would not like to be a burden on them. According to the characterizing statements, they strongly agreed they would participate in a dementia prevention program because their children expect them to do so . They also agreed that their participation depended on the fear of suffering dementia , the travel distance , and maintaining independence. Those who shared this perspective reveal similar narratives, for example, participants 03, 07, and 30 would participate in a dementia prevention program “at the request of their children”. Participants 03 and 30 expressed that “We still have certain forms of family activities, such as holiday reunions or occasional visits, so we were deeply concerned about problems of poor memory and health that may prevent us from participating in family activities”. Participants 03, 07, and 30 would like to “maintain independence to avoid becoming a burden on their family”. Participants with this perspective agreed with the importance of medical care and needed their providers’ recommendation. According to the characteristic statements, they agreed that “the medical expenses of suffering dementia would influence my participation in a dementia prevention program” . They agreed that “participating in a dementia prevention program can maintain my independence”  and “would like to participate in a dementia prevention program because of the advice of providers” .Those who shared this perspective pattern revealed similar narratives. For example, participant 20 emphasized that “I cared about my health and would participate in a dementia prevention program because of my physician’s advice”. Based on the 6C framework, this study revealed four perspectives of the elderly on a dementia prevention program. The four patterns of shared perspectives, which accounted for 54.65% of the total variance, included (a) the awareness of health benefits and readiness to take preventive actions; (b) emphasis on cost consideration and not ready to participate; (c) concern about family attitude and needing family support; (d) emphasis on medical care and needing their providers’ advice. Meeting their needs based on older adults’ various perspectives will enable more effective marketing and planning of dementia prevention programs for the elderly in need, increase their willingness to participate, and reduce obstacles to participation, so as to successfully promote the program.The elderly living alone have multiple risks  and a hiconsumers who are concerned about health benefits and barriers (ability to afford program requirements). A previous study [The first perspective group of elderly agreed most that a dementia prevention program can improve physical and mental health, improve physical activity, and increase their own knowledge, and that their own physical load would also influence their participation in the program. They give priority to attending to their own health and self-needs. Corresponding to the 6C marketing mix, they are classified as the pattern of us study  indicateus study . cost and convenience involved in participating in the program. A study which investigated the needs of attending a fall prevention program among older people, also revealed that time and cost associated with program participation should be taken into account in addition to relevant content  [The elderly people who fit into perspective pattern two agreed that it is critical to spend time and pay the cost of participating in a dementia prevention program, even if they already suffer MCI. Corresponding to the 6C framework, this pattern of elderly pay attention to the vention) . Programcommunity  and concern (aging impact) elements. Compared to the second perspective group, this group of elderly did not care about the cost of participating in the dementia prevention program. The elders who fit into perspective pattern three emphasized the burden on their children if they developed dementia and that their children’s encouragement would shape their willingness to participate. The desire to be a considerate parent was revealed as a motivation to protect children from becoming caregivers of a dementia patient. A previous finding indicated that older adults believed that health problems caused by falling were serious, and a fall prevention program could decrease the burden they place on their family . Our fincommunication and cost. Providers’ advice plays a critical role in initial receipt of a preventive health service, which is supported by the findings of a prior study [Elders who fit in with perspective pattern four shared the view of adhering to their providers’ advice. They have high trust and compliance with their providers, and are willing to take advice from them regarding dementia prevention. In addition, they agree that if they suffer dementia, it will incur subsequent medical costs, so they are willing to participate in a dementia prevention program. Corresponding to the 6C marketing mix, these elderly are associated with the elements of or study . The impOur findings increase the current understanding of the distinct perspectives of elderly people with MCI living alone regarding participation in a dementia prevention program. The participants also expressed comments associated with their Q sorts that enhance the appropriate interpretation of the study findings. Our findings could be beneficial in improving the effectiveness of interventions targeting older adults to reduce their risk of suffering dementia. Health professionals could apply appropriate marketing strategies to encourage older adults to engage in dementia prevention. Responsive approaches based on older adults’ perspective patterns would be beneficial for attaining more satisfactory dementia prevention. To our best knowledge, this is the first study to identify the perspective patterns associated with older adults with mild MCI, which could further inform suitable strategies and sustainable applications.The current study could not avoid some limitations. Including a comparison of gender differences would have advanced the understanding of similarities and differences between females and males in participating a dementia program. However, there were only eight male participants in the current study, and such a comparison could not be conducted. Gender comparison is encouraged in studies with sufficient sample size. Further, our study considered only community-dwelling, rather in-facility, participants. Older adults living in long-term care facilities may have different perspectives regarding their participation in a dementia prevention program. Hence, we suggest that future studies conduct a Q methodology study with a sample of older adults that includes those living in long-term care facilities.Our findings revealed the shared perspectives of four groups of community-dwelling elderly with MCI living alone. The exploration of clusters of the elderly with MCI could assist health professionals in acknowledging older people’s characteristic attitudes and responses towards participation in a dementia prevention program. These findings could serve as a useful guide for researchers and practitioners to develop tailored dementia-prevention programs targeting elderly people with MCI living alone.


The World Health Organization (WHO) defines an effective round of mass drug administration (MDA) for lymphatic filariasis (LF) as one that reaches at least 65% of the target population. In its first round of MDA in 2011–2012, the National Program to Eliminate LF in Haiti achieved a 79% epidemiological coverage in urban Port-au-Prince. In 2013, coverage dropped below the WHO threshold and has declined year-over-year to a low of 41% in 2017. We conducted a retrospective qualitative case study to identify key factors behind the decline in coverage in Port-au-Prince and ways to address them. Our findings suggest that the main contributors to the decline in MDA coverage appear to be the absence of effective documentation of practices, reporting, analysis, and program quality improvement—i.e., learning mechanisms—within the program’s MDA design and implementation strategy. In addition to their contribution to the program’s failure to meet its coverage targets, these deficits have resulted in a high cost for the MDA campaign in both lost momentum and depleted morale. Through a proposed operating logic model, we explore how the pathway from program inputs to outcomes is influenced by a wide array of mediating factors, which shape potential participants’ experience of MDA and, in turn, influence their reasoning and decisions to take, or not take, the pills. Our model suggests that the decisions and behavior of individuals are a reflection of their overall experience of the program itself, mediated through a host of contextual factors, and not simply the expression of a fixed choice or preference. This holistic approach offers a novel and potentially valuable framing for the planning and evaluation of MDA strategies for LF and other diseases, and may be applicable in a variety of global health programs. In order to eliminate lymphatic filariasis from a region, the World Health Organization recommends a strategy of preventative drugs delivered annually to the population. At least 65% of the population must participate for four to six consecutive years for this approach to be effective. In urban Port-au-Prince, Haiti, the number of people taking the drugs has been declining progressively below the 65% benchmark since 2012. We used a qualitative case study to identify key factors behind the decline in coverage in Port-au-Prince and ways to address them. We found that the lymphatic filariasis elimination program lacks the necessary design and program infrastructure to ensure reliable learning about problems faced by pill distribution teams on the ground, and the improvisations they introduced to address these challenges. The inability to incorporate these lessons into program improvements and refinements resulted in under-performance and contributed to the decline in coverage. Furthermore, the way that people experience the program is strongly influenced by a host of contextual factors, which shape potential participants’ experience of the program and, in turn, influence their reasoning and decisions to take, or not take, the pills. Lymphatic filariasis (LF) is a parasitic neglected tropical disease (NTD) that may cause severe pain, disfigurement, and disability. Like many other NTDs, LF disproportionately affects some of the world’s most impoverished populations . Those aWhile LF is still endemic in 72 countries worldwide, Haiti is one of only four endemic countries in the Americas, and one of two still requiring MDA in the region . LF affeThe problem of persistent LF in an urban area after many years of MDA is not unique to Haiti –14. UrbaIn addition to these common urban challenges, MDA implementation for LF in Port-au-Prince has faced a great number of political, physical, and social challenges, including political crises and instability resulting from the 2004 coup d’état, a devastating earthquake and subsequent cholera outbreak in 2010, and the 2016 strike from Hurricane Matthew  can’t respond to this. What they give it doesn’t respond every day for everyone when they have to climb when there isn’t water for people.”—Promoter“… for the zones that are up the mountain… sometimes we go on mule and I pay [for] the mule 200 or 300 gourdes.”—Community Leader“… the program used to give me 200 gourdes for phone cards to put on my phone for the year… so I use the money from my wife’s business to do the job… and I also use other money from work in the province…”—Community Leader“… Nearly every promoter and community leader mentioned having to use their own money or borrow from friends and family in order to fund transportation for themselves and the CDDs and to purchase supplies, such as food for CDDs on distribution days and snacks as incentives for community members to take the pills. One CDD said of his promoter that “he is the only one who will ask us how are we doing, if we have eaten, if we had something to drink, he is the only person to do so”.Payment and stipends to CDDs in both Tabarre and Carrefour communes was viewed as insufficient, poorly timed, late, or absent entirely. Underfunding or poor timing of the stipend has direct influence on the morale, and likely also the productivity, of CDDs . But desI have a strong devotion to this work. My group has three people and we all have a strong devotion to the work that we do. We collaborate amongst each other, we take the bag of water, the equipment that we have if they are all ready, and we organize ourselves so that we can do the distribution. We have a strong desire and volition to do this.”—Community Drug Distributor“The program lacks credibility among many of the internal stakeholders  and external stakeholders  we interviewed. This credibility deficit appears to arise from a lack of clarity about the identity of the program, i.e., its genesis, funding, supporting partnerships, aims, and value for Haitians, and is exacerbated by inconsistent branding and by its vulnerability to competing narratives, such as rumors that the government is using the program as a way to sterilize the population.Perhaps most importantly, the credibility of the program is undermined by the significant disconnect between the nature of the program—a medical and public health intervention—and its perception by many in the public—and even by some members of the drug distribution teams—as unprofessional and half-hearted.Choose a place that is favorable to give to them because it’s a medicine against a disease, you’ll choose a place that’s cleaner so people can have confidence to take it once the people arrive to a place that’s clean, it’s medicine they are giving, this could encourage them to take it, but if they find people sitting anywhere, people won’t give it any importance because of the way they are giving the medicine.”—Compliant Community Member“The medicine gives you gwogrenn (hydrocele). It hasn’t happened to me personally, but I know it’s happened to a lot of people. That’s one reason why I don’t take them. A lot of people don’t take the pills for this reason. It’s not that they are difficult to find–I choose not to take them. The people are easy to see, with their t-shirts. I don’t want to take medicine from these people with t-shirts. If a doctor told me I needed this medicine for a disease, then I would take it.”—Non-compliant Community Member“Data collection for the study was suspended on several occasions due to demonstrations and civil unrest in Port-au-Prince during critical data collection periods. These circumstances prevented travel, and intermittent phone and internet access during that time made communication impossible at times, hindering data collection and analysis.High- and low-coverage zones were defined by the number of pills distributed, as opposed to the percentage of a zone’s population that complied with MDA, due to an absence of denominator data. Distribution posts should, by theory, serve approximately 1,000 people each, but because of issues like daily commuting and the presence of large participating schools in some zones, the labels of high- or low-coverage may not be accurate.As a result of these limitations, we were unable to generate sufficient data to support specific zone-by-zone comparisons, as we had anticipated in our sampling strategy. We could not, with confidence, attribute differences between high-coverage and low-coverage areas to leadership, promotion, or day-of-distribution activities specific to those sites. By selecting communes and zones based on their reported rates of coverage and distribution, we hoped to increase the likelihood that we would be able to identify good practices by the drug distribution teams that might have contributed to high distribution and to compare them with the practices associated with low distribution outcomes. And we hoped to see any differences in drug distribution practices in each zone reflected in the attitudes and experiences of members of the general public  in those zones who had either agreed to take the drugs in a previous round of MDA, or who had not agreed to take the drugs. Instead, we have been limited to providing broader, programmatic analyses that we believe to be broadly applicable to all drug distribution efforts in Port-au-Prince.Evidence throughout the literature on LF MDA demonstrates that issues of non-compliance have plagued countries all over the world ,26,29,30Two observations are relevant here. First, our study was not designed to produce a survey of the rates and distribution of these rationales among non-compliant populations in metro Port-au-Prince. Second, such a study would be complex and expensive. More importantly, it is unclear how such a study would direct the actions necessary to improve the program’s performance. For example, we encountered people who took the drugs, but related similar concerns about the program as other people who did not take the drugs.when people go to [location of a drug distribution point]… they are mobilizing people to come take the medicine… [But] normally this place is very dirty, it became like a ravine, in this moment it’s where people drop all of their garbage and I see that it’s not good, and then it’s on the floor that they put the bags of water, this makes me not want to take the medicine in these places.”—Compliant Community Member“… In Haiti, I do not like the way the people give out the medication. That’s why I don’t even like to take it like that… when the people are sitting in the street to give out the medication, I don’t trust them.”—Non-compliant Community Member“Yes yes. I am not saying that I am scared of it… it’s the way they are distributing it in the street. If the center was stable where they are giving it out, whenever I feel something I would just go and say that I am going to this center.”—Non-compliant Community Member“As well, a survey of motivating rationales is typically cross-sectional and retrospective in nature, which can only treat the motivating rationales as fixed personal traits, independent of the influence of contextual factors. But this is a gross simplification of the social and psychological complexity of human decision-making. As a point of comparison, similar challenges have been addressed in other sectors, in particular in marketing and consumer purchasing behavior. Some of the key lessons from the academic business management fields provide an instructive analogy for understanding and addressing the challenges facing the LF MDA program outlined above.The first lesson is that consumers’ preferences, choices and brand-loyalty are powerfully influenced, not only by advertising, but also by their overall experience at the point of sale ,32 The sThese lessons provide a broader framing for our findings. They reinforce our analysis that the decisions and behavior of individuals—in this case the decision whether or not to take drugs in LF MDA campaigns—are a reflection of their overall experience of the program itself, mediated through a host of contextual factors, and not simply the expression of a fixed choice or preference. The lessons from consumer psychology also help us understand that these decisions are driven largely by perceptions of value. This shifts the burden from the prospective MDA participant to “make the right decision” to the program, to ensure that the prospective participant has a clear value proposition motivating their decision.It is a much simpler task to advertise the valuable features of a new mobile phone, than it is to explain the purpose, logic, and potential value of LF elimination, and MDA as the main tool to achieve it. But without a clearer and more persuasive account of the value of the MDA campaigns, many of the other competing influences described in our findings are likely to prevail and limit participation.Perhaps the most relevant and important lesson from the consumer psychology literature is the central importance of investment in learning strategies as the cornerstone of success in consumer markets. Successful companies make extraordinary investments in learning about consumer behavior in order to win customers and lock down their brand loyalty. These investments are in the form of a variety of research strategies—e.g., experimental economics, eye-tracking studies of customer attention, and on-line purchasing behavior patterns. But more importantly, they come in the form of the human and technological infrastructure required to translate the findings of these studies into effective management and implementation strategies . The maiThe lack of reliable learning strategies in the LF MDA program design has four main consequences. First, it means that there is no single accurate account of the program, as it is actually delivered, and therefore no reliable way to build a diagnostic evaluation of declines in the program’s performance. Second, it results in discouragement and, in some cases, disillusionment among some of the drug distribution teams, who are trying to make the program work by identifying and responding to challenges as they arise through the course of drug distribution and who may ultimately come to see these efforts as futile. Third, the inability to identify and address aspects of the program and contextual factors that have had a negative influence on prospective participants’ experience of the program, e.g., its perceived lack of professionalism, means that these factors are almost inevitably repeated in each successive round of MDA rather than being eliminated through specific changes to program design. And fourth, the lack of evidence that results from the absence of learning mechanisms compounds the already considerable challenge of evaluating such a complex program and represents a significant obstacle to meaningful accountability for funders and partners, and, more importantly, to the public, especially those Haitians who have taken the drugs over and over again through the multiple rounds of MDA.There are no obvious indications that the experiences of potential participants have been anticipated in the implementation plan or in the underlying theory of the LF MDA program in Port-au-Prince. There are no clear learning mechanisms built into the day-to-day operations of the program. As a result, there is no way to learn about how the program is operating in the various contexts of metro Port-au-Prince, and no way to feed that information back to inform program design and management. And, even if learning feedback loops did exist, it seems likely that the current program design and management structures would be inadequate to allow meaningful responses to the lessons learned. These are challenges for program management, but they almost certainly also reflect the progressive decline in the program’s budget, which necessitates a wide range of trade-offs and compromises, some of which almost certainly correspond to the factors described, above. The program lacks credibility with both the public and the drug distribution teams, and there is a general feeling from those teams that the forward momentum for the program comes from the bottom up , rather than from the top down, despite the challenges reported, above. We expect that these broad programmatic challenges are present in many MDA strategies for LF and other diseases and may therefore represent a significant opportunity to improve the performance of a wide range of global health programs.In light of these findings, we are currently working to implement the following recommendations:Revise the program’s implementation guide to address details of program delivery that are most likely to negatively affect prospective participants’ experience of the program.Establish the necessary documentation procedures and feedback channels for the drug distribution teams to help them capture important lessons about how the program is working—to enable the program to “learn-by-doing”—and to inform any necessary adjustments to the program’s design or management.Prepare an all-cost budget that addresses on-going logistical challenges for drug distribution teams  and explicit budget justifications for these projected costs. Use these revised budgets to facilitate dialogue and deliberations among funding partners about the feasibility of increasing budget allocations to more effectively address these chronic challenges.Create a comprehensive human resources policy for all drug distribution teams , including clear and realistic job descriptions, training strategies, compensation and incentives, and procedures for managing relationships with program management.Revisit or institute a memorandum of understanding between the international partners and the MSPP to ensure that: the auspices under which the program was created, and is being designed, delivered and evaluated can be clearly communicated to the community; the roles and contributions of international and Haitian partners, and their terms of participation are clearly defined; sources and levels of funding from each partner, their contributions to technical and operational support, and their commitment to the success of the program are clearly articulated and accurate; and the policies, governance structure and accountabilities that have been agreed to by the partners are publicly available.Develop a communications strategy for the program that directly addresses the public’s concerns as communicated by the drug distribution teams, such as the rates and severity of side effects, and confusion about the LF MDA program lasting more than five years.