Feasibility Study of the My Health Coach App for Adults With Fetal Alcohol Spectrum Disorders (FASD)
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Sponsor: University of Rochester

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NCT05604014
Feasibility Study of the My Health Coach App for Adults with Fetal Alcohol 
Spectrum Disorders (FASD)
Principal Investigators – Christie Petrenko, Ph.D & Cristiano Tapparello, Ph.D.
PREFACE
This study represents the third phase of a larger research project developed for a UH2 
application through the Collaborative Initiative on Fetal Alcohol Spectrum Disorders 
(CIFASD), which has been funded by the National Institutes on Alcohol Abuse and 
Alcoholism since 2003. The project aims to develop a mobile health (mHealth) application 
(app) for adults with fetal alcohol spectrum disorders (FASD). In the first phase (IRB Study 
#00004616), we utilized focus groups to engage adults with FASD in the development of the 
mHealth intervention, currently called “My Health Coach.” In our second phase (IRB Study 
0007156), we used an online survey to obtain feedback on the developed concept from a 
broader sample of adults with FASD. In this third phase, we are conducting a feasibility trial 
of the developed mHealth intervention. 
1. PURPOSE OF STUDY
This project is a partnership with identified leaders in the adult FASD community, known as
the Adult Leadership Collaborative (ALC). Their motto is: “Nothing About Us Without Us.”
The purpose of this study is to conduct a feasibility study of the My Health Coach app we have
developed from stakeholder feedback in prior phases. We will test both the acceptability and
feasibility of the app for adults with FASD as well as trial procedures. These data will inform
our future larger-scale randomized controlled trial.
We will recruit adults with FASD online through well-established methods by our research
group and our ALC partners. Eligible adults will try out the app on their own smartphones.
Online assessments will be completed at the start of the study and six weeks later. Interviews
will also be completed to further understand user experiences.
This project has the potential to make significant contributions to the field as there are currently
no evidence-based supports for adults with FASD.
2. BACKGROUND AND RATIONALE
Prenatal alcohol exposure affects the developing brain and other organ systems and can result
in a set of conditions termed fetal alcohol spectrum disorders (FASD; [1]). FASD are prevalent
conditions, affecting about 2 to 5% of the North American population [2]. Although FASD
have been primarily studied in children, it is well established that FASD are life-long
conditions that impact multiple domains functioning. Adults with FASD often require a higher
level of supports to participate in home, community, occupational, and social settings [3].
Despite the high prevalence, most people with FASD do not receive appropriate diagnosis or
services. Research has documented that 80% or more of people with FASD go undiagnosed
[4]. Getting an early diagnosis and appropriate services are two important protective factors
against mental health symptoms and other later life problems such as school disruptions,
trouble with the law, and substance use [3].

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Unfortunately, research on effective services for people with FASD is limited, and almost non-
existent for adolescents and adults. In addition, there are major barriers to accessing available 
services and supports in the community. Barriers to care occur because a knowledgeable and 
skilled workforce is lacking [5-6], and there are individual- and family-level barriers such as 
limited financial resources, transportation, and stigma [7].
This project will initiate formative research to guide the development of mHealth tools for 
adults with FASD. Most adults have a smartphone and mHealth apps have the advantage of 
being easily scalable and can reduce barriers to access. In addition, mHealth apps are well-
suited for providing information, self-monitoring, goal-setting, and real-time synchronous 
communication, all of which can be effective behavior change techniques [8]. 
Consistent with the Developmental Origin of Health and Disease (DOHaD) hypothesis, 
emerging research is documenting high rates of co-occurring chronic health conditions 
associated with prenatal alcohol exposure in humans and animal models [9,10]. In fact, the 
ALC has been instrumental in directing attention to this important issue and leading a large 
survey-based study on this topic [11]. Adults with FASD require concrete and accurate 
information to understand their condition and practical ideas to meet their needs and build on 
their strengths. Our mHealth app, currently called My Health Coach, will offer adults with 
FASD evidence-based education about their condition and tools to promote their own self-
management and health advocacy goals. My Health Coach is grounded in self-determination 
theory [12] and integrates well-established behavior change strategies [13]. It uses a just-in-
time adaptive intervention design [15] and a simple and engaging chatbot interface. This will 
provide adults just the right type and amount of support, when they are most receptive.
Partnering with the ALC to develop and conduct the research is an important strength of this 
study. Gathering key stakeholder input is crucial when developing new treatments and supports 
for a given condition. But partnering with identified leaders in the community to help shape 
the research questions and guide data collection and interpretation enriches the quality of the 
data and ensures the right questions are being asked. 
3. ADMINISTRATIVE ORGANIZATION  
This study is led by Drs. Christie Petrenko and Cristiano Tapparello. Dr. Petrenko is faculty at 
Mt. Hope Family Center and has appointments in the departments of Psychology and 
Pediatrics. Dr. Tapparello is faculty in the department of Electrical and Computer Engineering. 
They will oversee all research staff, implementation of human subjects’ protections, and data 
collection, management, analysis, and reporting. 
All data collection will be through our research team at the University of Rochester. 
Participants will be recruited online and complete informed consent, screening, and survey 
through our REDCap database, hosted at the University of Rochester. Interview data will be 
collected via HIPAA-complaint Zoom. Additional data will be collected through the My 
Health Coach app developed and managed by our team and hosted on a URMC Amazon Web 
Services (AWS) account. 
4. STUDY DESIGN

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This feasibility study will use a single group design with assessment timepoints prior to the 
receipt of the app and 6-weeks later. Primary outcomes assessed will include quality of life, 
self-determination theory constructs (i.e., autonomy, competence, relatedness), self-
management, and barriers to care. Acceptability of the app and trial procedures will also be 
assessed at the 6-week timepoint.
5. SUBJECT POPULATION
The study population will include adults (18+) with FASD. We will aim to enroll 48 adults 
with FASD to achieve a final sample of 40 participants with complete data. Additional 
participants will be enrolled if attrition is greater than anticipated. 
In prior studies conducted by the ALC, 45% of participants were from Canada, 40% from 
USA, 9% European countries, 5% Australia / New Zealand, and 2% African countries. As 
such, we anticipate the vast majority of participants in our study will also be from the US and 
Canada. However, some will likely come the EU and UK and fall under GDPR requirements. 
A “Notification for Collection and Use of Personal Data” is included in the REDCap Screening 
Module immediately after the Study Consent Form to inform all participants from the EU or 
UK about compliance with GDPR requirements. 
It is also possible that some adults with FASD will have legal guardians due to decisional 
impairment (in either specific or global domains). For these adults to participate, their legal 
guardian would also need to review the study consent form and provide written permission. 
Legal guardianship in Canada is rare but is used sometimes for adults with FASD in the US. 
A question in the screening module asks about legal guardianship. For those adults who 
indicate they have a legal guardian, our research team will contact that person to go over the 
permission form and obtain the needed signature through REDCap. 
6. INCLUSION AND EXCLUSION CRITERIA

Adult 18 years or older 

Have a history of prenatal alcohol exposure or FASD diagnosis (based on self-report)

Have fluency in English

Own an Android or iOS (iphone) smartphone

For adults with a legal guardian: their parent or guardian needs to provide written 
permission for them to participate
Participants who are not able to speak English will be excluded from the study at this time as 
the My Health Coach app and surveys are only currently available in English. 
7. RECRUITMENT METHODS
We will use well-established recruitment methods previously used by our University of 
Rochester research group and ALC partners. Recruitment materials include study flyers and 
social media tiles (see uploaded). These materials will be distributed as follows: 

Dr. Petrenko will share study recruitment materials with providers and community 
advocates who regularly interact with adults with FASD

We will post study information on our team’s Twitter account (@FMFConnect) and 
newsletter (www.fmfconnect.com) 

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
CIFASD investigators can inform research participants or patients in their local sites or 
clinics for which they have routine access

FASD United (Formerly National Organization on Fetal Alcohol Syndrome) is a 
member of CIFASD and has a mission to educate the public about FASD and 
disseminate research and policy information. They can disseminate the study flyer 
through their Weekly Round-Up newsletter, significant social media presence, and to 
their state and local affiliates who can share in their communities  

ALC partners will share recruitment materials through their social media and other 
networks 

Organizers/moderators of popular social media groups can be sent recruitment 
materials and can choose to share with their members 
We would also like to invite participants to consider participating in the current study who 
completed informed consent and screening for our prior focus group study (IRB Study 
#00004616) or online survey (IRB Study 0007156). These adults would be sent an email (see 
email language template) including the study recruitment flyer. Interested participants from 
prior studies would need to follow the same consenting and data collection procedures outlined 
below as other new participants. Recruitment materials would direct them to the REDCap 
Screening Module. 
8. CONSENT PROCESS
This study includes 2 documents: 1) Adult Information Sheet, and 2) Legal Guardian 
Permission. 
Interested adults with FASD will be directed to the link to the study REDCap Screening 
Module from recruitment materials. Participants will first be given the option whether they 
would like to learn about the study by 1) reading the Study Information Sheet or 2) view a 
video summarizing this information. After reviewing either option, they will be asked several 
questions assessing their understanding of the information. All participants will be given the 
option to download a copy of the Information Sheet for their records. This will also allow them 
sufficient time to review the form and discuss it with other people in their life if they choose. 
There will also be a section where they can indicate if they have any questions, and our study 
coordinator will call them. The study coordinator’s contact information will also be presented 
if participants want to contact the coordinator with questions while reading the 
document/watching the video. The study coordinator will document contact in the study 
contact log in REDCap. Additional items will screen for eligibility and obtain contact 
information. There will also be a question about whether they have a parent/legal guardian, so 
we can contact that person if needed to obtain permission. Given the broad range of functioning 
within this population, the Information Sheet language was adapted in some places to be at a 
lower reading level. Headings were also added, similar to the Adolescent Assent template.
We request a waiver for documentation for the Study Information Sheet. The primary 
identifying information collected as part of this study are participant contact information in the 
REDCap Screening Module. This contact information would allow us to contact participants 
in several anticipated scenarios, such as: if they indicate they have questions about the study, 
they provide inconsistent information we need to clarify (e.g., country they live in vs. response 

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for “live in UK or EU”), or to send them surveys or schedule interviews. This contact 
information would also allow us to remove or change participant data as requested by a 
participant under GDPR requirements if needed. Identifying information will be stored 
separately from other de-identified data sources. In addition, this study is minimal risk and 
involves procedures (e.g., survey responses, app usage) for which written consent is not 
normally required outside the research context. There is also not an easy way to verify 
participant identify for written eConsent without creating an additional step for participants 
involving communication with research staff through another method (e.g., email, phone). 
After reviewing the information sheet, participants will be directed in REDCap to answer 
screening questions to assess eligibility for the study (see Screening Form). If eligibility criteria 
clearly aren’t met (e.g., out of age range, no smartphone, etc), participants will be informed 
immediately that they aren’t eligible and the module will end. Screening data will be 
maintained for ineligible participants to aid in clinical trial reporting requirements (e.g., 
documenting numbers screening, eligible vs. ineligible, and reasons). 
For adults who appear to meet criteria or in cases where they answer “unsure” for any of the 
questions, further contact information will be gathered. Contact information will also include 
necessary variables to generate their “globally unique identifier” (GUID), which is used in 
other 
CIFASD 
studies 
and 
required 
for 
the 
NIAAA-Data 
Archive 
(https://nda.nih.gov/s/guid/nda-guid.html).
Legal Guardians: For legal guardians, written permission will be obtained using REDCap’s 
eConsent signature field. A study team member will contact the legal guardian based on 
information provided by the participant in their survey. During this contact the study team will 
provide the legal guardian a passcode to enter when completing the eConsent to serve as 
verification of their identity. The legal guardian will then select “Next Page” and a read only 
copy of the consent will be generated that they can review, download, and/or print. At the 
bottom of the page, they will need to select “I certify that all the information in the document 
above is correct, and I understand that signing this form electronically is the equivalent of 
signing a physical document.” Once this is selected, they will be able to submit the signed 
consent form. 
Upon completion of the permission survey, a static copy of their responses in the form of a 
consent-specific PDF will be stored in the project’s File Repository in REDCap (to allow for 
versioning). The e-Consent Framework in REDCap also records their IP address and displays 
this information in the file repository in order to help regulate potential duplicate forms from 
a single IP address. A PDF file of the completed consent form will be available for download 
by the user. The PDF can also be emailed to legal guardians or printed/sent to them in the mail 
on request if they are unable to open or save a copy electronically on their device. 
Participant completion of the study permission document also triggers an automatic 
notification to the study coordinator, who will log-in to REDCap and review the consent. She 
will then add her name and date to the eConsent document. However, the date study staff sign 
the eConsent may differ from that of the participant; for example, if the participant completes 
the forms on a weekend. The coordinator will also document the date of this review in the 

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study database and download a copy of the consent form to maintain in study records. Next 
the coordinator will review screening responses and demographic variables to assess eligibility 
and will document this in the study database. 
This study is funded by the National Institute of Health (NIH). A Certificate of Confidentiality 
is automatically included as part of the notice of award. Language regarding the Certificate of 
Confidentiality is included in the consent documents.
Due to an increase in fraudulent participants across studies, we have developed a lab-wide 
guide to minimize, detect, and systematically manage fraudulent participants (see uploaded). 
For this study (as of June 2023), if “red flags” (e.g., common email formula, unusual emails; 
see lab-wide guide for other examples) are identified by research staff, they will follow lab 
scripts to withdraw the participant.
9. STUDY PROCEDURES
The project research assistant will track participants in REDCap once enrolled and will 
facilitate timely completion of research assessments. All participants will be encouraged to 
complete assessments, regardless of their level of engagement with the My Health Coach app. 
Actual user data from the app (whether minimal or extensive) will be important in addressing 
study aims. 
     
After informed consent, participants will be asked to complete a set of baseline surveys (see 
details on the assessment battery below). To be most sensitive, given the unique 
neurobehavioral profiles of participants, administration will be flexible based on participant 
needs and can include surveys completed independently online, over the phone or Zoom with 
research staff, or through the mail. Afterwards, they will be provided information on how to 
install the app on their phones. Study staff will be available to troubleshoot problems with 
installation or app use. After 6 weeks, all participants will be re-contacted to complete follow-
up surveys. User implementation data will be gathered through the app. To further assess 
acceptability, satisfaction, and barriers and facilitators of app use, the study research assistant 
will complete qualitative interviews with participants over HIPAA-complaint Zoom or 
telephone. Interviews will be recorded and later transcribed verbatim. 
Study Assessment Battery
Measure
Baseline
6-Week 
Follow-up
Quality of Life: Personal Well-being Index – Intellectual 
Disability Version
X
X
Self-Determination: The Basic Psychological Need 
Satisfaction and Frustration Scale
X
X
Self-Management
X
X
Barriers to Healthcare Checklist
X
FASD Education 
X
Basic Demographics
X
Acceptability: Theoretical Framework of Acceptability 
measure
X

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Qualitative Interview on User Experience
X
 
Qualitative Interview. The semi-structured questioning route will cover the following topics: 
1) overall impressions of My Health Coach; 2) experience using the app (both facilitators and 
barriers of use); and 3) perceived impact on their health and well-being. Interviews are 
expected to last about 30 minutes. 
My Health Coach app. The My Health Coach app is designed to offer adults with FASD 
evidence-based education about their condition and tools to promote their own self-
management and health advocacy goals. It uses a chatbot interface to engage with users and 
help navigate through the app features. The user will be able to customize their chatbot as well 
as their own avatar to ensure they feel comfortable while using the app. Key features include 
a daily check-in, which records mood, physical health symptoms, sleep quality, and positive 
activities completed each day. Daily answers can be referred back to as needed. The app also 
includes a tracker the user can cusstomize to track things such as medication or daily tasks. 
Next, the app will also include a library where users can access evidence-based factsheets on 
their condition and strategies to aid with condition management. Lastly, the app will send a 
daily message notification. These will include strategies, FASD facts, and positive 
affirmations. 
10. AUDIO/VIDEO RECORDINGS 
Qualitative interviews will be recorded using HIPAA-complaint Zoom with a digital recorder 
audio back-up. Research staff will be at Mt. Hope Family Center when completing interviews, 
using UR computers. Recordings will uploaded from the local machine as soon as possible to 
a URMC Box folder for this project managed by the IT team at Mt. Hope Family Center. Only 
research staff involved on this project will have access to recordings. Recordings will then be 
transcribed verbatim by research staff. After all transcripts have been rechecked, audio and 
video recordings will be deleted. 
11. RISKS TO SUBJECTS
Participants may experience psychological risks associated with participation in this study, 
such as discomfort or boredom in answering questions or providing feedback about the app. 
There is also a risk of loss of confidentiality. All data collected for the proposed research study 
will be kept confidential to the extent allowed by law. Although it is unlikely given the nature 
of this study, if participants disclose that someone is being maltreated or is a danger to self or 
others, research staff will need to break confidentiality to make a report to the appropriate 
authority to ensure safety, as mandated by law. We believe that all identified risks are 
reasonable given the proposed procedures for protecting against risk.  
Protections Against Risks
To minimize risk associated with psychological discomfort, participants will be given the 
option to skip questions they feel uncomfortable answering. Multiple procedures will be 
implemented to protect participant confidentiality. In terms of data storage and management, 
any hard copy data will be secured in locked file cabinets within locked offices, available only 
to program staff. Electronic data will be stored on URMC managed Box folder for this project, 
and only project staff with appropriate permissions will be able to access the data. Forms with 

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identifying information will be separated from the data collected and only subject numbers 
will be retained in data analysis files.
Multiple levels of protection will be put in place to reduce the risk of loss of confidentiality 
for data collected through the app. A local datastore will protect the mobile application against 
network failures and connectivity issues. This local datastore will be transparently 
synchronized with the Cloud database so that all the querying and security features will be 
always available regardless of network connectivity. Collected data will be stored using a 
random code that will not allow direct identification of a particular subject, while any data 
that identify the user will be stored separately. All the connections between the mHealth app 
and the Cloud, as well as access and storage to the Cloud database, will use state of the art 
authentication and encryption algorithms (e.g., HTTS, SSL and TLS). The Cloud architecture 
and services will be built and are managed by Dr. Tapparello, under a University-managed 
Cloud account, and in compliance with University policy. Security and Benchmark 
compliance reports generated by Lacework will be received and reviewed daily by Dr. 
Tapparello. Access to the data stored on the Cloud will be restricted, access to the data with 
be logged and backups will be created to allow the users to restore them if/when necessary. 
Appropriate policies will be set up so that users will be able to add and modify their own data 
but will be prevented from viewing and modifying other users' data. My Health Coach will 
also not alter the security settings of the user’s phone, access stored information in the phone, 
or access device functionalities without explicit user consent. A passcode (or touch ID/Face 
ID) will be required to access the content of the app, and all the personal data stored by the 
app will be encrypted automatically whenever the device is locked. 
All information obtained for research will be kept strictly confidential (as allowed by law) by 
research staff. Participants will be told about all exceptions (e.g., child/dependent adult abuse, 
harm to self or others) to confidentiality during the consent process. Project staff will be 
closely supervised by Dr. Petrenko and instructed on confidentiality, including what 
information is confidential, the limits of confidentiality, and to whom to report concerns. 
The My Health Coach app is viewed as a “value-added” intervention. Participants can 
continue to receive care as usual in their community. The alternative to participating in this 
study is not to participate.
12. POTENTIAL BENEFITS TO SUBJECTS
Participants may not experience any direct benefits from participating in this study. However, 
participants in prior FASD research studies at MHFC have commented on how they value and 
derive personal satisfaction in participating in research to increase knowledge about this under-
recognized condition and effective strategies to benefit other people with FASD. It is also 
possible, although not guaranteed, that participants might derive benefit from using the My 
Health Coach app. Possible benefits may include improved self-management, advocacy, and 
quality of life.
13. COSTS FOR PARTICIPATION
There are no costs to participate. 

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14. PAYMENT FOR PARTICIPATION 
Participants will receive a $25 gift card for completing: baseline surveys, 6-week follow-up 
surveys, and the qualitative interview, for a possible total of $75 if all activities are completed.  
15. SUBJECT WITHDRAWALS
Subjects will be advised during the consent process that they have the right to withdraw from 
the study at any time without prejudice. They can choose to use the app as much as they want 
(or not at all). We are interested in obtaining survey data as well as feedback about the user 
experience from as many participants as possible, including those who chose not to use the 
app or found it hard to navigate. This information is useful in identifying ways to improve the 
app and facilitate user engagement. Subjects can choose not to complete any or all of the study 
assessments. They can also completely withdraw from the study with no future contact if they 
choose. In this case, any data they have previously provided may be used in analyses. 
16. PRIVACY AND CONFIDENTIALITY OF SUBJECTS AND RESEARCH DATA
All data will be used solely for research purposes and will be securely locked in designated 
file cabinets, URMC managed Box folder dedicated to project, Project REDCap database, and 
an encrypted, HIPAA-complaint Cloud database (AWS; for data collected via the app; see 
above). Identifying information will be stored separately from other data, which will be stored 
by research ID number (GUID). Multiple procedures will be implemented to protect 
participant data collected through the app, which are further detailed in the section 
“Protections Against Risks” and Data Security Assessment form. Only senior key personnel 
and project research staff will have access to the data.
The following table summarizes the project data flow. MHFC IT will set up and manage 
permissions for URMC Project Box folder. Only project staff will have access to REDCap 
and Box folders. Dr. Petrenko will coordinate with the CIFASD5 Coordinating Center to 
facilitate required data uploads to NIAAA-Data Archive as required by the grant for eligible 
de-identified data (pre-post surveys; all other data exempt). 
Data Element
How Data 
Collected
Where Data is 
Stored
How Data is Managed
Information 
Sheet, 
Screening 
Survey, 
Contact 
Information
REDCap
REDCap, Back-ups 
URMC Box
MHFC IT; Project Staff
Legal Guardian 
Permission 
Form 
(eConsent)
REDCap
REDCap, Research 
staff signed copy of 
permission form on 
URMC Box
MHFC IT; Project Staff
Baseline (T1) 
Surveys
REDCap
REDCap, Back-ups 
URMC Box, 
CIFASD/NIAAA-DA
MHFC IT; Project Staff; 
CIFASD5 Coordinating 
Center
6-week 
REDCap
REDCap, Back-ups 
MHFC IT; Project Staff; 

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Follow-up (T2) 
Surveys
URMC Box, 
CIFASD/NIAAA-DA
CIFASD5 Coordinating 
Center
Follow-up 
Interview
Zoom, back-
up audio 
recording
URMC Box
MHFC IT; Project Staff; 
Audio/video data is 
transcribed verbatim; 
audio/videos deleted once 
transcript verified
My Health 
Coach App 
usage data and 
User’s inserted 
data
User device 
synchronized 
with AWS
URMC-managed 
account on AWS
Access is restricted to 
authorized individuals and 
every access to the data will 
be logged, data is encrypted 
in transit and at rest. AWS 
account is set up in 
compliance with UR/URMC 
policies and monitored by 
Lacework.
15. DATA / SAMPLE STORAGE FOR FUTURE USE
All data (de-identified and identifying) will be securely stored locally for an indefinite period. 
De-identified and identifying information will be stored separately as detailed above. Novel 
research questions may arise in the future that this important dataset could answer. Future 
studies may also be interested in long-term follow-up of individuals who participated in this 
research. Retaining identifying information would facilitate contacting individuals 
(subsequent to new IRB approval) to see if they would be interested in participating in follow-
up research. MHFC has well-established data security procedures in place for long-term 
storage and maintenance of data. Only approved project staff will have access to data. 
De-identified pre-post data from this study will also be submitted to the National Institute on 
Alcohol Abuse and Alcoholism Database (NIAAADA) at the National Institutes of Health 
(NIH), as required. As a CIFASD Project, the CIFASD5 Data Coordinating Resource will 
facilitate required timely data harmonization and uploading to the NIAAADA. Recommended 
language has been included in the Information Sheet and Permission forms, including a link 
to more information about the data archive and sharing policies: https://nda.nih.gov/niaaa. 
16. DATA AND SAFETY MONITORING PLAN
Because the research involves the provision of a mobile health intervention for adults with 
FASD, the risk for a serious adverse event due to provision of the intervention is low. Adverse 
events that could occur in adults with FASD could include aggression or violence towards 
others, maltreatment, self-harm or suicidality, or the need for inpatient hospitalization. 
However, these occurrences are unlikely to be a direct consequence of participation in the 
proposed research or interventions. 
Dr. Petrenko will assume ultimate responsibility for the safety and well-being of research 
participants and the integrity of data collected. Dr. Petrenko has conducted several RCTs with 
children and adults with FASD and their families. She is a licensed psychologist in the state 

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of New York and is involved in other clinical and research activities at MHFC where 
maltreatment and suicidality are commonly reported.  
The well-being of participants will be monitored throughout the course of the proposed 
research. If there are concerns regarding a participant during interactions with research staff, 
staff will immediately contact Dr. Petrenko for consultation and a plan will be developed to 
address the concerns raised. Additionally, because MHFC provides other treatment programs, 
there are other back-up clinical supervisors available for consultation for immediate needs. A 
phone tree will be established, similar to other projects at MHFC, and will be provided to 
research staff. Dr. Petrenko will meet with research staff at least weekly to provide supervision 
and will assess participant well-being. Dr. Petrenko will consult with other co-Investigators 
and clinical staff at MHFC, as appropriate, to address participant well-being concerns. 
An independent safety monitoring board has also been established for the larger project, 
consisting of researchers and clinicians with relevant expertise with at-risk populations, 
clinical trial monitoring, and human subjects protections and technology. ISM members and 
their areas of expertise are listed in the following table: 
Name
Title & Affiliation
Relevant Areas of Expertise & 
Experience
Sheree 
Toth, Ph.D.
Director & Professor, Mt. 
Hope Family Center, 
University of Rochester
Clinical psychologist; developmental 
psychopathology; relational 
interventions; maternal depression; 
maltreatment; prevention of teen 
depression; has conducted multiple 
large-scale intervention trials with 
high-risk populations. 
Lynn Cole, 
M.S. PNP
Clinical Director, Kirch 
Developmental Services 
Center, 
Neurodevelopmental and 
Behavioral Pediatrics, 
University of Rochester 
Medical Center
Pediatric nurse practitioner; physical 
and mental health of children with 
developmental disabilities; intellectual 
disability, FASD, autism, and cerebral 
palsy. 
Anthony 
Pisani, 
Ph.D.
Associate Professor in 
Psychiatry and Pediatrics, 
Center for the Study and 
Prevention of Suicide, 
University of Rochester 
Medical Center
Clinical psychologist; suicide 
prevention; public health messaging; 
safe and ethical use of technology in 
prevention science
The ISM committee will review and suggest modifications to research protocols and consent 
documents to assure scientific integrity and adherence to human subjects’ protection policies. 
They will meet with the PI and co-Investigators twice a year to monitor safety issues and 
provide feedback on scientific and ethical issues relating to project implementation. The IRB 
will be notified immediately of any adverse events via telephone and submission of a 

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“University of Rochester Serious Adverse Event Report”. Such events would also be reported 
to NIAAA. The proximity of committee members will also facilitate their ability to monitor 
data management activities. The committee may ask to review data for quality control 
purposes.
Ethically, we are committed to ensuring the welfare of people with FASD. Any significant 
mental health or safety issues detected during the conduct of this investigation will be 
discussed with participants and options for the receipt of services presented. 
17. DATA ANALYSIS PLAN
Pre-Post Intervention Outcomes. Descriptive statistics, reliability indices, and pre-post effect 
sizes (Cohen’s d) will be calculated for baseline and follow-up quantitative measures and 
user implementation data. Data will provide useful estimates to inform larger randomized 
control trials of the app. Data will also guide further app refinements. 
Qualitative Interviews. Data will be analyzed thematically to understand users’ experiences 
with the My Health Coach app and research trial. The purpose is to inform further app 
development. Thematic analysis focuses on identifying patterns or themes within the data. 
Consistent with the approach advocated by Miles, Huberman, and Saldana [15], research 
team members will first familiarize themselves with the data, iteratively reviewing each 
transcript, and independently assigning initial codes (“first-level coding”). The team will then 
come together and discuss, operationalize, and refine each code. We will also generate 
“second-level codes” which consider categories or deeper meanings among first-level codes. 
During this process we will examine interrelationships and networks among codes and build 
a preliminary thematic framework. Transcripts will then be recoded and codes refined 
through further discussion and consensus, as needed. Participant and group “fit” with the 
framework will also be assessed, with confirmatory and disconfirmatory evidence for the 
model examined. Participant matrices may also be utilized to examine variance in themes 
across participants and key demographic factors, pre-post intervention change, or usage 
patterns.
18. REFERENCES
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