Feasibility trial of the My Health Coach app for adults with fetal alcohol spectrum disorders.

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Published in final edited form as: Res Dev Disabil. 2025 May 31;164:105053. doi: 10.1016/j.ridd.2025.105053 Feasibility Trial of the My Health Coach App for Adults with Fetal Alcohol Spectrum Disorders Emily L Speybroeck a, * , Christie Petrenko a, b, * , Cristiano Tapparello c , Cody Romanos c , Katrina Griffin d , Emily Hargrove d , Myles Himmelreich d , Anique Lutke d , CJ Lutke d , Maggie May d , Carson Kautz-Turnbull a , Madeline N Rockhold a , Julianne Myers a Author information Article notes Copyright and License information a Mt. Hope Family Center, Department of Psychology, University of Rochester, 187 Edinburgh St., Rochester, NY 14608 b Division of Developmental & Behavioral Pediatrics, University of Rochester, 200 East River Rd., Rochester, NY c Department of Electrical & Computer Engineering, UR Health Lab, University of Rochester, Computer Studies Bldg., Rochester, NY d The International Adult Leadership Collaborative of the FASD Changemakers ✉ Corresponding author: Christie Petrenko, Ph.D., Mt. Hope Family Center, University of Rochester, 187 Edinburgh St. Rochester, NY 14608, christie_petrenko@urmc.rochester.edu * These authors equally contributed to this work and should be listed as co-first authors Author Contributions Emily L. Speybroeck: Conceptualization; data curation; formal analysis; investigation; project administration; resources; visualization; writing - original draft Christie L.M. Petrenko: Conceptualization; formal analysis; funding acquisition; methodology; project administration; resources; supervision; writing - original draft Cristiano Tapparello: Conceptualization; funding acquisition; resources; software; writing - original draft Cody Romanos: Conceptualization; resources; software; writing - review & editing Katrina Griffin: Conceptualization; resources; writing - review & editing Emily Hargrove: Conceptualization; resources; writing - review & editing Myles Himmelreich: Conceptualization; resources; writing - review & editing Anique Lutke: Conceptualization; resources; writing - review & editing CJ Lutke: Conceptualization; resources; writing - review & editing Maggie May: Conceptualization; resources; writing - review & editing Madeline N. Rockhold: Investigation; writing – review & editing Carson Kautz-Turnbull: Investigation; writing – review & editing Julianne Myers: Writing – review & editing Issue date 2025 Sep. PMC Copyright notice PMCID: PMC12340602  NIHMSID: NIHMS2086905  PMID: 40450957 The publisher's version of this article is available at Res Dev Disabil Abstract Objectives: Fetal alcohol spectrum disorders (FASD) affect health and development across the lifespan. Adults with FASD experience significant barriers to care. Together with the International Adult Leadership Collaborative of FASD Changemakers, an international group of self-advocates, a mobile health application was co-created to support self-management and health advocacy. This feasibility trial assesses the My Health Coach app to determine readiness for a larger randomized controlled trial (RCT). Methods: Eligibility for this online trial included adults with FASD or known prenatal alcohol exposure who had conversational and literacy fluency in English. Adults received the app for 6 weeks on their personal smartphones (iOS or Android). Pre- and post-intervention assessments included quality of life, basic psychological needs based on self-determination theory constructs (autonomy, relatedness, competency), self-management, and app acceptability. User experience interviews were also conducted post-intervention. Usage and app crashes were monitored. Study objectives assessed feasibility of the trial (recruitment, attrition, study procedures, measure sensitivity), intervention (technical functionality, acceptability), and implementation (app usage). Results: Recruitment strategies proved sufficient with 95 adults screened and 43 deemed eligible. Analyses identified variables related to attrition. Study procedures were considered acceptable. Measures showed good acceptability and psychometric properties. The My Health Coach app was functional and acceptable to participants. Several refinements to trial infrastructure and construct measurement were identified for future RCTs. Conclusions: The My Health Coach app is feasible and shows promise in supporting adults with FASD with condition management. Trial results prove sufficient to proceed with a larger RCT to test efficacy. Keywords: Fetal alcohol spectrum disorders, FASD, adults, mobile health tools, mHealth, community engaged partnerships, feasibility trial Graphical Abstract 1. Introduction Fetal alcohol spectrum disorders (FASD) are lifelong developmental disabilities that can impact nearly every bodily system ( Moore & Riley, 2015 ; Popova et al., 2023 ). Neurodevelopmental domains impacted by prenatal alcohol exposure (PAE) include attention, executive functioning, learning and memory, self-regulation, and adaptive functioning ( Mattson et al., 2019 ; Moore & Riley, 2015 ). People with FASD often have notable character strengths such as social motivation, specific talents and passions, and resilience ( Flannigan et al., 2021 ; Kautz-Turnbull et al., 2022 ). In recent years, adult self-advocates have spearheaded and inspired increased investigation of the physical health and quality of life (QOL) impacts of PAE ( Hargrove et al., 2024 ; Himmelreich et al., 2020 ; Moritz et al., 2023 ). This work showcases higher rates of physical health conditions in children and adults with FASD, which may occur at earlier ages than in the general population. QOL for people with FASD is often negatively impacted by low awareness of FASD, stigma, barriers to care, and adverse life experiences ( Hargrove et al., 2024 ; Petrenko et al., 2014 ; Roozen et al., 2020 ; Streissguth et al., 2004 ). Most FASD diagnostic clinics and available support programming focus on the child and adolescent period, leaving a dearth of resources for adults. Recent reviews identified only five empirical studies testing interventions for adults with FASD ( Flannigan et al., 2020 ; Olson et al., 2023 ). As a result, adults with FASD are often left searching for information online to understand their diagnosis and find supports. Unfortunately, much of this information presents stigmatizing views of FASD ( Roozen et al., 2020 ). The quality and accuracy of information is variable, and the literacy level of materials can be a poor fit. Adults with FASD have called for practical tools and supports to assist with everyday living. Existing interventions are limited and typically provider-driven ( Flannigan et al., 2020 ; Olson et al., 2023 ). Given growing interest in mobile Health (mHealth) interventions for individuals with developmental disabilities ( Jones et al., 2018 ; Korczak & Zwierzchowska, 2020 ), comparable smartphone use with the general population ( Morris et al., 2016 ), and higher health disparities ( Himmelreich et al., 2020 ), adults with FASD are well-suited for mHealth solutions. An app could provide a scalable, self-directed tool to help manage everyday tasks and improve QOL for this population. 1.1. Co-creation of My Health Coach Intervention The larger study represents a partnership between researchers at the University of Rochester and the International Adult Leadership Collaborative (ALC) of FASD Changemakers, a group of adult self-advocates with FASD (partnership henceforth referred to as “the team”), to co-design and test the effectiveness of a mHealth app for adults with FASD called My Health Coach (MHC). Development was guided by self-determination theory (SDT), which posits three basic psychological needs influence a person’s motivation and QOL: autonomy (i.e., ability to direct and make choices in one’s life), competence (i.e., have adequate knowledge and skills to complete valued tasks), and relatedness (i.e., connection with others) ( Ryan & Deci, 2000 , 2018 ). Meeting these needs leads to a state of thriving, marked by vitality, awareness, and the full expression of one’s capacities and self-regulation ( Ryan & Deci, 2018 ). The MHC app was designed to support the three basic psychological needs of individuals with FASD, enhancing their QOL and functioning. The team utilized a user-centered design approach, which involved engaging community members throughout the development and evaluation process, and is detailed in Speybroeck et al. (2024) . Briefly, the team first developed and refined an initial interactive prototype. Next, the team co-conducted focus groups on a HIPAA-compliant online meeting platform (Zoom) to elicit end-users’ perspectives on app design and functionalities. An online survey was also co-developed to elicit feedback from a wider group of adults with FASD. Findings from focus groups and surveys were co-analyzed and recently published ( Speybroeck et al., 2024 ). MHC was designed to be a “just-in-time adaptive intervention” (JTAI) ( Nahum-Shani et al., 2018 ) that provides tailored support at key moments based on decision rules. For example, if a user responds to a query about mood and indicates they are experiencing anxiety, the app can suggest a relaxation exercise. If the user does not respond to the query or indicates they are feeling relaxed, the app will not provide an intervention in that moment. Consistent with findings from prior research on mHealth features for people with developmental disabilities ( Morris et al., 2016 ; Setiawan et al., 2019 ), MHC was designed with a simple and engaging interface to feel familiar and easy to navigate. The app utilizes a coach-like chatbot intended to feel like texting, which is an experience most adults with developmental disabilities are comfortable with and do frequently ( Morris et al., 2016 ). Interactions can be initiated by the chatbot or user. The chatbot initiates a “daily check-in” which includes four prompts assessing a user’s 1) mood, 2) physical health symptoms, 3) quality of sleep, and 4) plans for a positive activity for the day, which were deemed the most important areas by ALC partners. Consistent with the JITAI design, responses to these prompts provide opportunities for supportive messaging and recommendations of other app tools. Development objectives for the app’s core features were creating tools that were easy to use without significant training or memorization, and to boost the user’s QOL by simplifying certain day-to-day tasks. The app was developed using Flutter 3, which allowed app development to be compatible with iOS and Android devices from a single codebase ( https://flutter.dev/ ). The app included (see Figure 1 for representative screenshots): Figure 1: MHC App Prototype Screenshots. Open in a new tab Representative screenshots of app prototype, including (from left to right) Tracker Tool, Relaxation Tool, Library, and Daily Messages Daily messages and check-in to promote behavior change and engagement; A behavioral tracking feature where users create “trackers” to maintain regular reminders to, e.g., take medicines, eat, etc.; A Strengths Assessment tool to translate user’s abilities to a tangible list of strengths; A Relaxation tool with auditory stress management exercises; A Library with factsheets on information regarding FASD. MHC is the first mHealth intervention to address common challenges for adults with FASD all in one app. The Tracker helps manage memory challenges, the Library provides evidence-based information in plain language, and the Daily Check-in supports recording of challenges. The Strengths Assessment provides a strengths-based approach, often lacking for this population, while Daily Messages provide practical information. With minimal navigation steps, chatbot support, and ALC-approved language, MHC provides strategies specific for FASD not found within other apps. 1.2. Aims of Current Feasibility Trial The current feasibility study represents the next step in the user-centered design approach, aiming to test feasibility of a future RCT ( Eldridge et al., 2016 ). Although development of the app prototype was informed by possible end-users, the app has not been previously tested on individuals’ personal devices. In addition, outcome measures were modified, and piloting was deemed necessary to assess acceptability and sensitivity. The current study had the following aims: Aim 1. Trial Feasibility 1a. Were study procedures acceptable? 1b. Is recruitment sufficient to support a larger trial? Who is reached? 1c. How much attrition occurs? 1d. Are measures acceptable and sensitive to change? Aim 2. Intervention Feasibility 2a. Does the app work from a technology standpoint? 2b. Do users find it acceptable? Aim 3. User Implementation 3a. What are the usage patterns in the app? 2. Materials and Methods 2.1. Study Design This study was pre-registered at ClinicalTrials.gov (Identifier: NCT05604014 ) on October 28, 2022. The study used a single group design testing the feasibility of the MHC app with adults with FASD or known PAE. Assessment timepoints included baseline and 6-week follow-up. Primary outcomes assessed included QOL, SDT constructs (i.e., autonomy, competence, relatedness), self-management of daily tasks, and perceived barriers to care. Acceptability of the app and trial procedures were also assessed at the 6-week timepoint using an online survey and qualitative interview. Usage data was collected within the app. No significant changes were made to the study design throughout the trial. However, due to an increase in suspected fraudulent participants, an enhanced screening protocol was created and implemented on June 23, 2023, to better evaluate eligibility of participants (see 3.1.2 for details). 2.2. Participants A priori targeted sample size was 40 participants with usable data based on recommendations for feasibility trials ( Browne, 1995 ; Kieser & Wassmer, 1996 ). Informed by prior lab app feasibility trials ( Petrenko et al., 2021 , 2024 ), target enrollment was set to 48 participants to achieve a final sample of 40, after accounting for anticipated attrition (20%). Participants were recruited through established networks of the team including FASD listservs, social media, and targeted recruitment efforts. A sample of 43 eligible participants was achieved from March 20, 2023, to July 5, 2023 (see 3.1.2 for additional details). Inclusion criteria included: 1) eighteen years or older, 2) self-reported PAE or FASD diagnosis, 3) fluency in English, 4) ownership of an Android or iOS device, and 5) if applicable: written legal guardian permission. 2.3. Procedures All study procedures were approved by the University Institutional Review Board. Interested adults were directed to the study Screening and Consent Module on REDCap hosted by the University of Rochester’s ( Harris et al., 2009 , 2019 ). Participants were given the option to learn about the study by reading the Study Information Sheet or viewing a video summarizing the information. A “Notification for Collection and Use of Personal Data” was included immediately after the Study Consent Form to inform all participants from the EU or UK about compliance with General Data Protection Requirements. For adults with a legal guardian, the guardian was contacted to review the permission form and obtained their signature through REDCap. Eligible participants were then directed to complete demographic questionnaires. After informed consent and demographic surveys, participants completed baseline surveys. Surveys could be completed independently online with accessibility accommodations such as audible text readers, over the phone or Zoom with study staff, or through the mail. After baseline surveys were complete, participants were provided app installation instructions. Study staff were available to assist with installation or app use. After 6 weeks, all participants were sent follow-up surveys and invited to a qualitative interview. All participants were encouraged to complete assessments, regardless of app engagement. Interviews were conducted over Zoom. Participants received $25 per timepoint for completing baseline surveys, follow-up surveys, and qualitative interview, for a possible total of $75. After completion of data analysis, the team co-created a document and video explaining results (see Supplemental Materials 10.2 ). This was sent to participants as a member check, allowing them to confirm results or provide feedback ( Creswell & Miller, 2000 ). All eligible participants (n=43) were sent the member check, with nine participants responding, all of which confirmed results reflected their experience in the study and with the app. 2.4. Measures Particular attention was paid to wording in measurement selection and refinement to increase accessibility for those with FASD. ALC partners called for concrete and concise language, which prompted the team to review each measure item to assess for clarity. A table of measure items and their edits can be found in Appendices 9.1 and 9.2. ALC partners also informed research staff that traditional Likert Scales can be confusing for adults with FASD. In response, the team co-created a 5-point multi-modal scale ( Figure 2 ). The scale ranges from 1 “Not true” to 5 “Very true.” The scale used words, visuals (sad to happy face), and stair steps labeled with numbers. Each step represented a potential answer. For reverse scored items, 5 “Very true” and 1 “Not true” and the faces on the scale were flipped ( Figure 2 ). Before participants were given access to the baseline and follow-up surveys, they were prompted to watch a 1 minute 38 seconds video explaining the scale. A transcription of the scale instruction video is provided ( Supplementary Materials 10.1 ). To minimize confusion and allow for consistency, the scale was used for every measure besides the Theoretical Framework of Acceptability measure, as ALC partners deemed the original scaling acceptable. No changes were made to study measures once the trial began. Figure 2: Measure Scales. Open in a new tab Co-created, multi-modal scale ranging from 1 “Not True” to 5 “Very True.” Reverse coded items ranged from 5 “Not True” to 5 “Very True” Demographic Information (baseline): Demographic information was collected during the initial screening assessment. Variables included age, sex at birth, gender identity, race, ethnicity, country of residency, and smartphone operating system. Personal Well-being Index – Intellectual Disability Version (PWI; baseline and 6-week follow-up) ( Cummins et al., 2010 ): The PWI is an 8-item measure assessing how participants feel about their material, physical, mental, and general well-being. Adequate internal reliability of the PWI-ID with diverse samples has been reported ( Cummins et al., 2010 ). While the stair scale ( Figure 2 ) was used in place of the traditional 5-point Likert scale, scoring was consistent with manual instruction, creating a composite score from items 2-7 ( Cummins et al., 2010 ). High levels of internal consistency were seen at baseline (α=.80) and follow-up (α=.83) The Basic Psychological Need Satisfaction and Frustration Scale – Adapted from English Children Version (BPNSF; baseline and 6-week follow-up) ( Chen et al., 2015 ): The BPNSF is a 24-item scale assessing both satisfaction and frustration relating to the three basic psychological needs identified in SDT: autonomy, competence, and relatedness. Items on the original scale are rated on a 5-point Likert scale from 1 “Not at all true” to 5 “Completely true.” General and domain-specific versions of the BPNSF have been tested and validated in diverse samples ( Chen et al., 2015 ). Scoring was consistent with manual instruction, creating composites for total overall satisfaction and frustration as well sub scores for autonomy, relatedness, and competency ( Van Der Kaap-Deeder et al., 2020 ). Overall, fair to high levels of internal consistency were seen across subscales at all timepoints (αs ranging from .51 to .84). Self-Management Survey (baseline and 6-week follow-up): Two versions of this scale were created for this study, tailored for the different timepoints. Item content was informed by other scales assessing self-management ( Sawicki et al., 2011 ), activities considered important in daily life by the ALC ( Hargrove et al., 2024 ), and targets of the app. The baseline scale had 12 items assessing participants’ perceived ability to manage physical health (e.g. medication, hygiene, sleep, stress) and access to FASD information. The follow-up scale had 11 items focused on how the app supported daily functioning, including managing health, tasks, health care visits, and recognizing strengths. See Appendix 9.3 for specific items. Scoring consisted of frequency of occurrence. Acceptable levels of internal consistency were found at baseline (α=.74) and follow-up (α=.87). Theoretical Framework of Acceptability (TFA; 6-week follow-up) ( Sekhon et al., 2022 ): The TFA is a 7-item scale assessing acceptability of design, evaluation, and implementation phases of healthcare interventions. Original wording and scaling were deemed acceptable by ALC partners. Scoring consisted of frequency of occurrence and reported at the item level. Qualitative Interview (6-week follow-up): The semi-structured questioning route covered the following topics: overall impressions of the app; experience using the app (both facilitators and barriers); perceived impact on health and well-being; and what it was like to participate in the study (see Appendix 9.4). Participants were encouraged to share negative criticism and constructive feedback to minimize positive bias. Interviewers consisted of full-time Bachelor’s- and Master’s-level research staff and graduate students including authors ELS, CKT, and MNR. Four interviewers identified as female, and one identified as non-binary. Interviewers had two to five years’ experience working with the FASD community. All interviewers were trained by CP in qualitative interviewing methods. Interviewers did not have previous relationships with participants prior to study commencement. Interviews were recorded and later transcribed verbatim, with interviewers taking notes throughout. Interviews were scheduled for 30 minutes and averaged 25 minutes, 36 seconds ( SD =9.97), ranging from 9 minutes, 31 seconds to 44 minutes, 39 seconds. Interviews were conducted via Zoom; however, three participants were given the opportunity to provide written feedback upon request due to apprehension with conversational English, protection of the confidentiality of their FASD diagnosis, and scheduling issues. Only one participant responded in written form. Some participants had caregivers present during the interview. While caregivers were allowed to contribute, interviewers were instructed to gather confirmation from the participant on caregivers’ contributions. Usage Data: Analytics and app usage data were collected and extracted for processing from a HIPAA compliant Amazon Web Services (AWS) backend. During app use, app events were recorded directly to AWS. These events included opening the app, factsheets, audio relaxation files, interactions with the chatbot or strength assessment, and feedback shared through the feedback submission portal. 2.5. Data Analysis Mixed method data analyses were guided by feasibility objectives, as specified in Table 1 . Table 1: Data Analysis Objective Data Source Data Analytic Method 1. Trial Feasibility 1a. Were study procedures acceptable? Qualitative interviews Thematic qualitative analysis 1b. Is recruitment sufficient to support a larger trial? Who is reached? CONSORT diagram; Participant descriptive data Frequencies, means, and standard deviations 1c. How much attrition occurs? CONSORT diagram; Participant descriptive and baseline data Descriptive statistics; Attrition analyses – t-tests, chi-square 1d. Are measures acceptable and sensitive to change? Surveys at baseline and 6-week follow-up; Qualitative interviews and study staff notes on acceptability of study measures Descriptive statistics; reliability indices; Cohen’s d effect sizes; t-tests 2. Intervention Feasibility 2a. Does the app work from a technology standpoint? Bug and crash reports in AWS; Feedback provided by users in app; Email communication; Qualitative interviews Descriptive statistics; Thematic qualitative analysis 2b. Do users find it acceptable? TFA survey at 6-weeks; Qualitative interviews Descriptive statistics; Thematic qualitative analysis 3. User Implementation 3a. What are the usage patterns in the app? Usage data from AWS Descriptive statistics; Correlations Open in a new tab Data analyses plan, describing trial aim, data source, and analytic method Quantitative data were aggregated and summarized with descriptive statistics as relevant for data type and objective. Reliability indices, pre-post effect sizes (Cohen’s d), and t-tests were also calculated for baseline and 6-week follow-up survey data to assess measure properties and the degree of change over time. Qualitative data were analyzed thematically to understand users’ experiences with the app and research trial to inform future app development and trials. The coding team, led by ELS and overseen by CP, included three full-time research staff. Using Dedoose (2021) , coders applied thematic analysis to identify patterns and themes. Following Miles et al.’s (2014) approach, coders first reviewed transcripts and applied initial codes based on an a priori codebook from prior lab studies ( Petrenko et al., 2021 , 2024 ). Codes included structural codes (app components), evaluation (positive/negative), and recommendations. Coders refined codes through discussion and then applied second-level codes to identify categories or deeper meanings. This developed a preliminary thematic framework, with coders then assessing how well participant data “fit” with the model by examining confirmatory and disconfirmatory evidence. 3. Results 3. 1. Trial Feasibility 3.1.1. Were study procedures acceptable? (Aim 1a) Study staff documentation and qualitative interviews suggested overall study procedures were acceptable to participants. Many participants commented on the importance of researching and creating interventions for adults with FASD. One participant stated, “ I liked that adults are being targeted. To get what we struggle with. And what an app would be helpful for. So that’s what I liked, and that we were listened to and our ideas were considered important ” (P046). Several participants identified barriers to signing up for the study, which included difficulties with the process to gain legal guardian permission, the font of the surveys being hard to read, and concerns about the study’s legitimacy given it was entirely online. Most participants stated the surveys were easy to complete. Most participants completed the surveys independently online, with two participants contacting study staff to clarify the meaning of some items. Participants felt the options to have questions read aloud and to pause and revisit the surveys were helpful. 3.1.2. Is recruitment sufficient to support a larger trial? Who is reached? (Aim 1b) As shown in the CONSORT diagram ( Figure 3 ), 95 subjects initiated enrollment in the REDCap Consent & Screening module. A total of 52 subjects did not meet eligibility criteria (see Figure 3 ). Study staff suspected fraudulent participants after an exponential increase in signups within a span of twenty-four hours. After consulting with other research professionals (personal communications, May 2023) ( McLachlan et al., 2024 ), a lab-wide protocol was created, and study staff were trained to identify participant information consistent with standard suspected fraudulent flags. Figure 3: CONSORT Diagram. Open in a new tab CONSORT diagram for trial A total of 43 subjects met inclusion criteria. High interest in the study was demonstrated, with 89% of the targeted goal (n=48) enrolled after six weeks. This suggests the ability to enroll a sample of sufficient magnitude for a larger-scale RCT. Table 2 provides demographic information for eligible participants. Sample demographics are similar to those reported in previous surveys with adults with FASD ( Hargrove et al., 2024 ; Himmelreich et al., 2020 ). Table 2: Sample Demographics Characteristics Participant (n=43) Age (years) Mean (SD) 28.10 (11.19) Range 18.02 – 59.55 Sex at birth, n (%) Female 34 (79.1) Gender Identity, n (%) Boy/man 9 (20.9) Girl/woman 29 (67.4) Transgender, gender queer, or non-binary 4 (9.3) Choose not to answer 1 (2.3) Ethnicity, n (%) Hispanic/Latine 3 (7.0) Not Hispanic/Latine 28 (65.1) Unknown 5 (11.6) Choose not to answer 7 (16.3) Race, n (%) African American/Black 3 (7.0) Asian, Native Hawaiian, or Pacific Islander 2 (4.7) White 29 (67.4) Native American/Alaska Native 5 (11.6) More than one race 2 (4.7) Unknown 1 (2.3) Choose not to answer 1 (2.3) Country, n (%) United States 24 (55.8) Canada 7 (16.3) Netherlands 4 (9.3) United Kingdom 4 (9.3) Ireland 1 (2.3) Italy 1 (2.3) New Zealand 1 (2.3) South Africa 1 (2.3) Formal FASD Diagnosis, n (%) Yes 34 (79.1) Age at Diagnosis (years), n=34 Mean (SD) 14.28 (12.68) Range 0-59 Operating System, n (%) iOS 18 (41.9) Android 25 (58.1) Open in a new tab Sample demographics, (n=43) 3.1.3. How much attrition occurs? (Aim 1c) The CONSORT diagram ( Figure 3 ) shows attrition rates across study procedures including baseline survey completion, app installation, and follow-up completion. Chi square analysis and independent sample t-tests were used to determine if participant demographics, baseline survey responses, and app usage were associated with attrition at any timepoints (as applicable). Overall, 91% of participants completed baseline surveys. No demographic variables were related to completion of baseline surveys ( p s>.05). A total of 34 participants installed the app, representing 87% of those who received it. No demographic variables were related to installation ( p s>.05). Participants with higher total psychological need satisfaction on the BPNSF at baseline were more likely to install the app, t (26)=2.68, p=.01. No other baseline measure scores were related to app installation ( p s>.05). Six weeks after receiving the app, 72% of participants completed follow-up surveys (n=28). No demographic variables, baseline measure scores, or usage data were related to completion of follow-up measures ( p s>.05). A total of 19 participants completed interviews (5 iOS, 14 Android) or 49% of those who received the app. No demographic variables, baseline, or follow-up measure scores were related to participation in the interview ( p s>.05). App usage was related to interview participation, with those who opened the app ( p =.003), interacted with the chatbot ( p =.002), used the relaxation tools ( p =.03), and created trackers ( p =.04) more frequently being more likely to participate. 3.1.4. Are measures acceptable and sensitive to change? (Aim 1d) Study staff documentation and qualitative interviews identified overall the measures were acceptable to participants. However, some participants identified the surveys as burdensome. For example, one participant emailed, “ I am getting tired of doing all these forms, it is just the same question over and over ” (P019). The flipping of the scale for reverse-scored items was also identified as confusing for many participants. Effect sizes from baseline to 6-week follow-up on the PWI and BPNSF scales were generally small and reflected slight mean increases over the study period. These ranged from .13 to .27. The baseline version of the self-management skills measure provided ratings of individuals’ perceived functioning across a variety of tasks. Memory challenges ( M =2.46, SD =1.5) and having a trusted source to learn more about FASD ( M =2.43, SD =1.3) were the areas in which participants felt the least confident, while completing daily tasks ( M =3.61, SD =1.16) and knowing information about FASD ( M =3.61, SD =1.37) were areas in which they felt the most confident. At follow-up, the self-management skills measure assessed how the app assisted participants with these tasks. In general, participants felt the app was most supportive with taking medications correctly ( M =3.75, SD =1.21) and completing daily tasks ( M =3.46, SD =1.35). Participants felt the app was least helpful with managing doctor’s appointments ( M =2.79, SD =1.32), talking to providers about symptoms or FASD ( M =2.79, SD =1.34), and getting better quality sleep ( M =2.61, SD =1.40). 3.2. Intervention Feasibility 3.2.1. Does the app work from a technology standpoint? (Aim 2a) Most participants reported app installation was easy. Study staff documented eight participants who needed support downloading the app, specifically with installation steps or having login information sent multiple times. Overall, the app was reported as stable, with minimal issues or crashes. There were two app updates during the trial. The first addressed operating system compatibility, enabling the app to run on older Android systems. The second was to fix minor bugs. Feedback about app functionality was gathered via a submission form in the app and in qualitative interviews. The feedback form received 33 submissions: 12 about app issues (10 resolved with updates), 20 recommendations (4 addressed with updates), and 1 positive comment. Problems included issues with screens loading and chatbot conversations stuck in loops. Recommendations focused on improvements to the Tracker and Daily Message features. No other technological issues were shared. 3.2.2. Do users find it acceptable? (Aim 2b) Scores on the TFA were generally in the good to very good range (3.5-4 out of 5). Users liked the app, found it well-suited for people with FASD, and felt confident using it. They reported minimal effort required and little to no interference with daily tasks. Feedback on the individual app components is organized in Table 3 . Results were largely positive, highlighting ease of use, accessibility, and acceptability of design. Negative impressions and recommendations to improve app features were also shared. Table 3: Individual Components Individual Component Positive Impressions Representative Quotation Negative Impressions Representative Quotation Recommendations Message of the Day Motivating Uplifting Informative Served as reminder to use app “ Those were pretty cool. I liked them. They were really informative ” (P022) Too long Too many Message navigation “ Because I get a ton of different notifications about things, I usually didn’t read them ” (P021) Library Comprehensive Organized Empowering Inspiring Information easily accessible “ It was useful for when I needed to share facts about FASD ” (P002) Relevance of information “ It just didn’t interest me ” (P035) Search feature Specific content Daily Check-in Supportive Easy to use Novel “ How it went step by step ” (P010) Generic responses “Especially now that AI is so big, this is not the most creative AI bot” (P024) Navigation changes More indepth and engaging interactions Notification to complete check-in Relaxation Tool Easy to use “I like that it has breathing techniques and it helps you through them” (P013) “ Relaxation is very good but for me no good because it’s in English ” (P030) Reminders Visuals Additional tools Additional languages Strengths Assessment Positivity Availability of strengths Design features “I thought the graphics at the end were fun. The confetti.” (P040) Lack of practical use/application “Once you complete them, there isn’t really anything else to like add to it” (P004) Ability to retake assessment Tracker Tool Helpful Design features “That was really nice to be able to put that all together” (P017) Navigation/ease of use Limited functionality (e.g. inability to set multiple reminders, lack of note taking capability Having supports already in place “I’m so used to just going through my day using what I have. I would forget it was there” (P046) Increased interactions/personalization Ability to view completed tasks Greater editing ability Logo and Icon ( Figure 4 ) Attractive “ I like it. It was really simple ” (P027) Blended with other apps “I don’t like the color” ( P009) More color Open in a new tab Feedback on individual app components, organized by positive and negative feedback, representative participant quotes, and recommendations for feature enhancement 3.3. User Implementation 3.3.1. What are the usage patterns in the app? (Aim 3a) Table 4 shows usage data for different app features. Seven participants (21%) installed the app but never opened it, meaning 27 participants opened and used the app at least once. Means across usage metrics show adequate participant usage of features, allowing meaningful assessment of app feasibility aims. Table 4: Usage Data Totals and Operating System Comparisons Component iOS Android Total Sample Mean (SD), Range T-test Comparisons iOS vs. Android App opened 20.45 (20.89) times Range: 1-72 48 (52.34) Range: 3-202 37.39 (45.41) times Range: 1-202 t (28.7)=−2.11, p =.04 * Chatbot interactions 46 (54.1) times Range: 0-154 106.58 (117.38) Range: 0-378 81.25 (101.04) times Range: 0-378 t (34.7)=−2.18, p =.04 * Daily Check-ins 5.13 (6.23) Range: 0-18 10.54 (12.16) Range: 0-38 8.25 (10.48) times Range: 0-38 t (24.13)=−1.75, p =.09 Strengths Assessment 22.2 (18.76) Range: 0-37 30.83 (14.09) Range: 0-38 26.82 items completed (of 37 total) (16.73) Range: 0 - 37 t (34.7)=−2.18, p =.04 * PDFs opened in Library 2.4 (4.95) Range: 0-18 9.46 (11.7) Range: 0-40 6.58 (10.12) times pdfs opened Range: 0-40 t (33.56)=−2.61, p =.01 ** Audio files opened 1.07 (2.31) Range: 0-9 1.92 (2.48) Range: 0-9 1.55 (2.41) Range: 0-9 t (37)=−1.07, p =.15 Number of trackers created 3.33 (9.21) Range: 0-36 3.67 (4.77) Range: 0-20 3.45 (6.65) trackers Range: 0-36 t (37)=−.15, p =.89 Trackers completed 31.93 (85.51) Range: 0-317 77.46 (150.64) Range: 0-590 58.45 (128.8) Range: 0-590 t (37)=−1.07, p =.29 Feedback submitted .67 (1.84) Range: 0-7 1.5 (2.99) Range: 0-13 1.15 (2.59) Range: 0-13 t (37)=−.97, p =.34 Open in a new tab Means, standard deviations, and ranges for usage data. T-test comparisons between iOS and Android users * p <.05, ** p <.01 T-tests were used to compare usage between iOS and Android users (see Table 4 ). Android users were more likely to open the app, interact with the chatbot, use the Library, and complete the Strengths Assessment compared to iOS users. No other differences were found. 3.3.2. Facilitators and Barriers to App Use Participants described the tutorial videos showing how to use different app features and the app’s notifications as facilitating app use. Additionally, some users said the app helped them remember to complete everyday tasks, which facilitated increased app use. Key barriers to app use included memory challenges, with many users requesting more reminders and notifications. The Daily Message was often ignored because it was sent in the morning when users were busy. Some participants already had established routines or supports, making the app unnecessary. Others struggled to understand the app’s features or found learning them overwhelming. Lastly, some users needed caregiver support, such as one participant who could not use Daily Messages or the Library due to reading difficulties. 4. Discussion 4.1. Primary Findings As a critical step of the systematic user-centered design approach ( Petrenko et al., 2021 ), this study aimed to assess the feasibility of trial logistics, intervention, and user implementation of the MHC app. This step is critical prior to investment in a large-scale RCT, especially as this type of intervention and trial have not been attempted with this population. Trial logistics proved feasible, with strong interest and recruitment. This feasibility trial also helped identify several aspects for improvement prior to a large-scale trial, including use of a fraudulent participant protocol, and revision of measures to increase reliability and utility in evaluating change over time. App usage data demonstrated the MHC app was technologically functional and acceptable for adults with FASD. Participants offered valuable recommendations for refinements to inform subsequent versions. App usage patterns also provided guidance for feature refinement prioritization. For example, the Tracker was the most utilized feature; thus, efforts are underway to expand its functionality, consistent with participant feedback. Overall, results provided evidence of feasibility and support proceeding with a larger RCT to test effectiveness. 4.2. Strengths and Limitations This study had many strengths. It is the first mHealth intervention for adults with FASD. Adults with FASD have advocated for research and interventions targeting this lifelong disability. The MHC app provides scalable and accessible support to daily challenges while also providing trusted, strengths-based information about FASD, all of which are not found in other apps for individuals with developmental disabilities. Furthermore, the app has been systematically co-developed with the ALC, a group of leaders in the FASD community. Additionally, other adults with FASD have provided feedback on initial prototypes ( Speybroeck et al., 2024 ). Including end-users in multiple design process steps ensures the product is acceptable and will aid in dissemination and effectiveness of future iterations. Another strength was co-designing the study procedures. The team co-developed accessible survey wording and scaling for adults with FASD, which likely contributed to high completion rates and positive participant feedback. Additionally, incorporating lessons learned from previous development steps, such as video consent forms and audio options for survey items, likely helped successful study completion. Overall, researcher and community partnership has allowed the team to consider key barriers and facilitators that may impact the implementation of the app in real-world settings ( Bauer et al., 2015 ). Results of this study should also be considered with the following limitations. First, the future RCT should engage a more diverse sample in terms of race, ethnicity, and gender. Some demographic variability may have been limited by the study only being available in English. To broaden reach, the future RCT could consider more targeted recruitment in countries outside of North America or offer the study in additional languages. Next, future studies could adjust self-management measurement for more effective pre- and post-intervention comparisons. Although current measure design was useful in obtaining information on where adults felt confident in managing daily tasks, a redesign could more effectively assess change after app use. Another barrier was confusion due to flipping the scale for reverse coded items. Additional efforts should be made to mitigate this confusion. Some participants also noted they would have liked more communication from study staff during the trial. Future studies could consider sending weekly email reminders. Lastly, bias could have been introduced at several points including data collection, data analysis, and interpretation of results. Responses from member checking suggest this is less likely but cannot be eliminated. 4.3. Applicability to Other Interventions and Populations The number of studies conducting formative app development research for adults with developmental disabilities has increased in recent years ( Bendixen et al., 2017 ; Jessen et al., 2021 ; Salgado et al., 2018 ). Unfortunately, few apps have undergone systematic development with empirical testing or community member engagement ( Xu & Liu, 2015 ). To date, the few trials conducted with individuals with developmental disabilities on self-management apps have involved smaller-scale usability or feasibility trials. The “interactive Mobile Health and Rehabilitation (iMHere)” app is the most well-studied self-management intervention for people with disabilities. Initially tested with adults with spina bifida and spinal cord injuries ( Dicianno et al., 2016 ; Parmanto et al., 2013 ), it was later adapted for broader use with individuals with chronic conditions and disabilities ( Setiawan et al., 2019 ). A growing number of studies have also examined the feasibility of apps promoting physical activity and diet with people with intellectual and other developmental disabilities (e.g., ( Michalsen et al., 2023 ; Pérez-Cruzado & Cuesta-Vargas, 2017 ; Savage et al., 2024 ). However, further systematic research, especially larger scale RCTs, are greatly needed. The established systematic user-centered design approach to app development and evaluation ( Petrenko et al., 2021 ) can provide useful guidance to designing mHealth interventions that are relevant and acceptable to targeted populations. A key element of the approach is researcher and community partnership and iterative feedback from the targeted population throughout each stage of the development process. Efforts in adapting measurement wording, scaling, use of accessibility features, and member checking also have utility for studies engaging a range of participants with diverse neurodevelopmental strengths and challenges. For example, the multi-modal co-developed response scale proved versatile across several measures and was understandable to participants with a wide range of abilities. This scale, its instruction video, wording changes of measure items, and member checking materials could be applicable to other studies testing apps in similar populations (see Appendices 9.1, 9.2; Supplementary Materials 10.1 , 10.2 ). Additionally, while tailored for FASD, the MHC app has functionalities and design features likely relevant for adults with other developmental disabilities and chronic health conditions. Across our formative development work ( Speybroeck et al., 2024 ) and current feasibility study, participants commented on their needs for memory and executive functioning supports and how the app can help with these. As such, the MHC app may benefit people with similar support needs and could be adapted and/or tested more broadly. 4.4. Future directions Next steps include advancing the functionalities of the current app using participant feedback from this study. Feedback supported acceptability of core features and provided directions for future development efforts. Given the ability to attain recruitment targets in a timely manner, and demonstrated acceptability and feasibility of the app and study design, there are grounds to move forward with a larger RCT. Results from this feasibility trial will help improve study procedures for the larger RCT, including more email communication from study staff, informing participants of app features, and adaptations to the measurement battery. If evidence supporting the effectiveness of the MHC app is established in future RCTs, subsequent efforts will assess strategies to facilitate dissemination of the app on a broader scale. These efforts could include linguistic and cultural adaptations of the app for a broader range of adults with FASD, as well as exploring appropriateness for individuals with other disabilities or health conditions. The MHC app could also be a useful tool in a broader continuum of care, such as an adjunctive tool in a provider-implemented program or efforts to increase provider knowledge and competencies in serving adults with FASD. Supplementary Material 1 NIHMS2086905-supplement-1.docx (16.5KB, docx) 2 NIHMS2086905-supplement-2.docx (13.7KB, docx) 3 NIHMS2086905-supplement-3.pdf (883.1KB, pdf) 4 NIHMS2086905-supplement-4.doc (219.5KB, doc) Figure 4: MHC App Logo and Icon. Open in a new tab App logo (A) and icon (B) Highlights. Assessed feasibility of My Health Coach app for adults with FASD Adults used the app for 6 weeks, with pre- and post-intervention assessments Study evaluated recruitment, attrition, measure sensitivity, and app functionality Recruitment succeeded with 95 screened, 43 eligible, and attrition factors identified Findings show the app is feasible and ready for a larger randomized controlled trial Acknowledgements We would like to thank Alicia Roth, Shuo Zhang, Weiyi Li, Mina Boyd and additional staff at Mt. Hope Family Center for their support throughout the project. We would also like to thank Jan Lutke for her support of the ALC members. The authors appreciate all the participants and their support networks who made time in their busy schedules to participate in this study. This research would not have been possible without their valuable insights. Funding Sources This research was supported by the National Institute of Health under Award #UH2AA029050. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Health. This work was done in conjunction with the Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD, https://doi.org/10.5967/ntw9-h991 ), which is funded from the National Institute on Alcohol Abuse and Alcoholism (NIAA). Additional information about CIFASD, including information describing available data, can be found on www.cifasd.org . We also appreciate the help from FASD United and the CIFASD contributors who assisted in recruitment. 9. Appendices 9.1. PWI Edits Original Measure Edits (bolded) Justification for Edits How happy do you feel about your life as a whole? Do you feel happy with your life as a whole? Changed "how" to "do" for clarity. This change allows for participants to break the question into two parts: Y/n, and then how much. How happy do you feel about the things you have? Like the money you have and the things you own? Do you feel happy about the things you have? Like the money you have and the things you own. Changed "how" to "do" for clarity. This change allows for participants to break the question into two parts: Y/n, and then how much. How happy do you feel about how healthy you are? Do you feel happy about how healthy you are? Changed "how" to "do" for clarity. This change allows for participants to break the question into two parts: Y/n, and then how much. How happy do you feel about the things you make or the things you learn? Do you feel happy about what you have achieved so far ? Changed "how" to "do" for clarity. This change allows for participants to break the question into two parts: Y/n, and then how much. Changed Make/things you learned to "achieved" for clarity. How happy do you feel about getting on with the people you know? Do you feel happy overall about the relationships with people you have in your life? For example, friends, family, partners, etc. Changed "how" to "do" for clarity. This change allows for participants to break the question into two parts: Y/n, and then how much. Changed "getting on" to "relationships" and added examples for clarity, added "overall" to avoid participants who might have one bad relationship currently How happy do you feel about how safe you feel? Do you feel safe in your life ? Changed "how" to "do" for clarity. This change allows for participants to break the question into two parts: Y/n, and then how much. How happy do you feel about doing things outside your home? Do you feel happy about doing things outside your home around other people? For example, group activities, grocery shopping, or community events. Changed "how" to "do" for clarity. This change allows for participants to break the question into two parts: Y/n, and then how much. Added "around other people" to specify this is about being social. Added examples for clarity How happy do you feel about how things will be later on in your life? Do you feel optimistic or positive about your future ? Changed "how" to "do" for clarity. This change allows for participants to break the question into two parts: Y/n, and then how much. Reworded for clarity Open in a new tab 9.2. BPNSF Edits Original Measure Edits (bolded) Justification for edits Regularly Scaled Items I feel free to choose which activities I do Do you get to choose the activities you do? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) ∣ removed "extra" language to make question clearer The people that I like, also like me. Do you think the people that you like, also like you? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) I can do things well Do you feel there are things you do well? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) I do the things I do because I really want to do them. Do you do things because you really want to do them? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) I feel close to the people I care about. Do you feel close to the people you care about? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) I am good at what I do. Overall, do you feel you are good at what you do? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) ∣ Added "overall" to clarify this is an "in general" question I choose to do the things I do because I want to do them. Do you choose to do things because you want to do them? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) I feel close to and connected with the people who are important to me. Do you feel connected to the people who are important to you? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) ∣ removed "extra" language to make question clearer I can achieve my goals. Do you feel like you can achieve your goals? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) I find the things I do really interesting. Are the things you do interesting to you ? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) ∣ removed "extra" language to make question clearer I have warm feelings towards the people I spend time with. Do you have positive feelings towards the people you spend time with? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) ∣ Changed "warm" to "positive" for clarity I am good at difficult tasks. Are you good at difficult tasks? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) Reverse Scored Items Most of the things I do, I do because I have to. Do you feel like the things you do; you do because you have to? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) I feel excluded from the group I want to be a part of. Do you feel left out from the groups you want to be a part of? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) ∣ changed "excluded" to "left out" for plain language ∣ changed "group" to "groups" as participants can be involved in more than one community I often have doubts about whether I’m good at things. Do you have doubts about whether you’re good at things? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) ∣ removed "extra" language to make question clearer I feel forced to do many things that I actually do not want to do. Do you feel forced to do things you don’t want to do? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) ∣ removed "extra" language to make question clearer I feel that the people who are important to me are unkind to me. Do you feel important people in your life are unkind to you ? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) I feel disappointed in a lot of things I do. When you do things, do you feel disappointed with the outcome? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) ∣ Changed wording to clarify this is about results of actions I feel pressured to do too many things. Do you feel pressured to do too many things? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) The people I spend time with don’t like me. Do you feel like the people you spend time with don’t like you ? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) I feel insecure about what I am able to do. Do you feel insecure about what you are able to do? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) I do the things I do every day because I have to, not because I want to. Do you do the things you do every day because you have to? (Rather than because you want to?) Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) ∣ Broke sentence into two parts for clarity. I feel that the relationships I have with other people are easily broken. Do you feel that the relationships you have with other people are easily broken? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) I sometimes feel like a failure when I make mistakes. Do you sometimes feel like a failure when you make mistakes? Changed from statement to question. This change allows for participants to break the question into two parts: Y/n, and then how much y and how much no (see scale) Open in a new tab 9.3. Self-management Baseline Items Does your doctor or healthcare provider understand FASD? Do you have the tools or knowledge to help your doctor or health care provider adequately understand your FASD? Do you feel like you are managing your physical health well? Do you take medication, vitamins, or supplements? If you take medication, do you remember to take all your medications correctly every day? Do you get a quality night's sleep at least three times a week? Do you have the tools or knowledge to help you get quality sleep? Can you manage daily tasks such as showering or eating? Do you feel like you manage your stress well? Do you feel like you know a lot about FASD? Do you have a trusted source where you can learn more about FASD? Does memory impact your ability to complete day to day tasks, such as taking medication, eating, or cleaning? 9.4. Interview Questioning Route Tell me about your experience with the My Health Coach app. Examples of additional probes (as needed): What do you like about it? What parts worked well for you? What did you not like about the app? What did not work well? For Users with Low Use or No Installation: Focus mainly on engagement barriers, technology, who they think the app would be good for. For Users with At Least Some Use of App: Topic: Engagement For Users with minimal to no use: What motivated you to sign up for this study? How did the app differ from your expectations? What kept you from using the app more? For Users with some use: What motivated you to want to try out the My Health Coach app? Follow-up probes for any pattern of use: What helped you keep using the app? What were barriers that kept you from using the app? Tell me about anything in the app that was annoying or kept you from wanting to use the app Were there any patterns in how or when you used the app? (e.g., certain times, places, locations) Topic: Technology How easy or hard was it to use the app from a technology stand point? Follow-up probes: Did you have any problems installing the app? Were there any parts of the app were difficult to use? What would make is easier to use and navigate the app? Topic: Utility How helpful do you think this app is overall for adults with FASD? Follow-up probes: Which part of the app helped you the most? Who do you think this app would be most helpful for? What would you change about the app to make it more relevant or useful for you? Topic: Strengths Assessment Did you like the strengths assessment? IF YES: What did you like about it? What did you not like about it? What would make this feature better? IF NO What kept you from using it? What didn’t you like about it? What would make this feature better? Topic: Relaxation tools Did you like the relaxation tools? IF YES: Did you find the relaxation tools helpful? What did you like about them? What did you not like about them? What would make this feature better? IF NO What kept you from using them? What didn’t you like about them? What would make this feature better? Topic: Daily Check-in Did you like the daily check-in? Follow-up Probes: Was the check-in easy to do? Was the check-in ever annoying or boring to do? Did you find the check-in helpful? Did you ever look back at your answers or the summaries the app makes? If yes: How did you use them? What would make this feature better? Topic: Tracker Did you use the tracking tool in the app? If YES: What types of things did you track? Did you find tracking helpful? What did you like about it? What didn’t you like about it? What would make this feature better? If NO: What kept you from using it? What didn’t you like about it? What would make this feature better? Topic: Messages of the Day What did you think about the Messages of the Day? Follow-up Probes: What did you like about them? What did you not like about them? Topic: Library Did you look at any of the factsheets in the Library? Follow-up probes: What content interested you most? Is there any content you want to see more of in the Library? Did you share the factsheets with anyone else? Topic: Logo/Icon What did you think about the icon or logo of My Health Coach? Topic: Recommended New Features Do you have any other ideas of features that would make the app better? Topic: Study Participation We want to know what it is like for people to participate in our studies. What did you like about being in this study? What did you not like about being in this study? Was there anything that was confusing or hard to do? Sign up for the study Complete surveys Install and use the app Do you have any suggestions to make this study better next time? Footnotes Conflicting Interests The authors declare that there are no conflicts of interest. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. 12. References Bauer MS, Damschroder L, Hagedorn H, Smith J, & Kilbourne AM (2015). An introduction to implementation science for the non-specialist. BMC Psychology, 3(1), 32. 10.1186/s40359-015-0089-9 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] Bendixen RM, Fairman AD, Karavolis M, Sullivan C, & Parmanto B (2017). 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