Feasibility Trial of the FMF Connect Mobile Health Intervention
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Sponsor: University of Rochester

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Feasibility Trial of the FMF Connect Mobile Health Intervention
Principal Investigators 
Christie Petrenko, Ph.D., Mt. Hope Family Center (MHFC), University of Rochester, 187 Edinburgh St., 
Rochester NY 14618
Cristiano Tapparello, Ph.D., University of Rochester, Computer Studies Building 511, Rochester, NY 
14627
1.
PURPOSE OF STUDY 
This study represents the second phase of a larger research project developed for a U01 award as part 
of the Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD) funded by the 
National Institute on Alcohol Abuse and Alcoholism (NIAAA). The overall project aims to develop 
and evaluate a mobile health (mHealth) application (app) for parents/caregivers of children with fetal 
alcohol spectrum disorders (FASD). 
The first phase of this project was approved under IRB protocol #1266 (legacy RSRB#67394). In that 
phase we used qualitative research methods to engage parents and caregivers in the development of 
the mHealth intervention and obtain iterative feedback on acceptability and feasibility. A prototype of 
the app was completed in both iOS and Android and beta-testing was completed with 
parents/caregivers and providers. 
In this second phase of the study, we are aiming to conduct a larger feasibility trial of the app with 60 
parents/caregivers. Data collection will include quantitative pre-post surveys and qualitative 
interviews with a subsample of users. Our hypothesis is that quantitative measures will show 
improvements in child behavior, parent FASD knowledge, parenting self-efficacy, behavior 
attributions, family needs met, and parent use of self-care. We also hypothesize parents/caregivers to 
rate app quality positively. These quantitative indicators are expected to correlate with patterns of app 
usage. This quantitative data will allow us to calculate pre-post effect sizes, which will inform needed 
sample sizes for the large-scale hybrid effectiveness-implementation randomized controlled trial 
(RCT) planned in phase 3 (IRB approval will be obtained prior to phase 3 implementation). 
Qualitative interview data will provide a rich context for the feasibility of the app and offer further 
insights into fine-tuning of the app and measurement battery prior to the RCT.
2.
BACKGROUND AND RATIONALE 
Children with fetal alcohol spectrum disorders (FASD) have significant neurobehavioral impairments 
that contribute to poor adaptive function and increased behavior problems in home, school, and 
community settings [1]. Most interventions for preschool and school-aged children with FASD, the 
largest age group with identified FASD [2], are directed at caregivers or have included parent training 
to facilitate child skill acquisition [3]. Interventions directed toward caregivers are an essential 
component of FASD integrated care models [3,4]. Tailored FASD-informed caregiver interventions 
provide families with the knowledge and skills to better understand their children’s development and 
behavior, generate effective environmental accommodations and behavior plans, teach and generalize 
targeted child skills, and advocate for their children in school and community settings [3]. These 
strategies are vital for sustained child improvement and better family adaptation. 
Unfortunately, we and others have documented that the vast majority of families cannot access 
FASD-informed interventions. Barriers to care occur because a knowledgeable and skilled workforce 
is lacking [5,6], and there are family-level barriers such as limited financial resources, inability to 
access childcare, and stigma [7]. Access to appropriate FASD-informed care is even more limited in 
less densely populated areas. Many families try peer-to-peer and self-help strategies, but it can be 

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difficult to evaluate the credibility and effectiveness of information provided through these 
modalities. 
The primary objective of this project is to develop and evaluate an mHealth app to directly provide 
caregivers with evidence-based content and peer-moderated support they can easily access and use to 
improve outcomes for their children and families. The app, called “FMF Connect,” will be derived 
from our work on the scientifically-validated Families Moving Forward (FMF) Program that has 
shown promising results for child and caregiver outcomes in three trials with families raising children 
with FASD [8]-[10]. 
This project will follow a systematic approach to the development and evaluation of the FMF 
Connect mHealth intervention. The app will be designed for use by caregivers, will utilize a cloud-
based infrastructure, and will build on our existing open source framework for the development of 
medical apps [11], and those of others [12,13]. Preliminary feasibility tests and iterative feedback 
from diverse caregivers will aid in fine tuning caregiver instructions, content, and user-interface 
features throughout the development process. Core content will be provided to all users, with optional 
features tailored via needs assessment. 
In this and subsequent phases, the FMF Connect mHealth intervention will be evaluated to identify 
the patterns of app usage that relate to the greatest improvements in child and caregiver outcomes. 
Consistent with prior FMF trials, targeted outcomes include satisfaction, child behavior problems, 
caregiver FASD/advocacy knowledge, attributions of misbehavior, parenting practices, parenting 
efficacy, self-care, and social support. This novel mHealth intervention has the potential to reach 
many families in need and reduce significant barriers to care, resulting in broader public health 
impact. Project findings will guide further app development both in terms of content and 
technological advances to optimize intervention effects. 
3.
ADMINISTRATIVE ORGANIZATION  
This study will be conducted through the University of Rochester (UR) and will involve faculty, 
students, and staff within the following departments and centers: Department of Psychology, Mt. 
Hope Family Center (MHFC; which is a part of the Psychology Department), Department of 
Electrical and Computer Engineering (ECE). Dr. Petrenko’s primary appointment is at MHFC and the 
Psychology Department. She oversees the study coordinator, research assistant, and graduate and 
undergraduate students working on the project within these departments. Dr. Tapparello is faculty 
within ECE and oversees staff and students within these departments contributing to the project. 
Weekly project lab meetings ensure coordination across all aspects of the project. 
All data collection and communication with participants is completed by UR project staff. Consenting 
and screening data, contact information, and quantitative survey pre-post data will be collected and 
stored online using REDCap hosted by UR. Participant interaction with the app is recorded using 
Amazon Web Services (AWS; HIPAA-Compliant). Qualitative interview data will be gathered by 
research staff using HIPAA-compliant Zoom videoconference application. All paper and electronic 
files will be securely stored on MHFC servers and in locked cabinets only accessible to UR project 
staff. 
As part of CIFASD, this study may involve data sharing as outlined by the policies and procedures 
established by CIFASD and required by NIAAA: https://cifasd.org/data-sharing/ . De-identified data 
will also be stored in the CIFASD Central Repository hosted at Indiana University (IU), as is required 
by NIAAA for all projects involved in CIFASD. 
 
4.
STUDY DESIGN

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This study involves a single arm feasibility trial. Quantitative survey data will be collected prior to 
intervention delivery and 3-months later. App usage will also be recorded during the 3-month period. 
After 3 months, a subsample of participants will be selected to complete a qualitative interview about 
their experiences using the app. Primary study outcomes include child behavior, parent FASD 
knowledge, parenting self-efficacy, behavior attributions, family needs met, and parent use of self-
care. We are also interested in participant perceptions of app quality and patterns of app usage. 
5.
SUBJECT POPULATION
The subject population will include parents and caregivers of children (ages 3-12) with fetal alcohol 
spectrum disorders (FASD) or affected by prenatal alcohol exposure (PAE) who live in the United 
States. 
We are aiming to include 60 parents or caregivers with usable data in this study. We expect a portion 
of families will enroll in the study, but not complete assessments or install the app. In our initial beta-
testing trials, 80% of families installed and used the app at least once. Unfortunately, given the 
COVID-19 pandemic, participation rates are trending lower than observed in prior trials. As a result, 
we will target 120 parents and caregivers in the trial.  
It is also possible that interest in the study will exceed our intended final sample size. Given that 
informed consent procedures will occur online, we have set the number of subjects at 300. If 
enrollment quickly exceeds 120, we will utilize stratified random sampling with oversampling of a 
couple of underrepresented groups (i.e., biological parents, men). 

Strata may include region of the US, operating system (iOS vs. Android), or other variables 
depending on the number of participants and their relevant characteristics. 

We will plan to oversample any biological parents who enroll in the study (up to 20% of the 
sample, and then randomize any remaining with the rest of the sample after that), as their 
perspective is underrepresented in FASD research and they represent an important 
demographic for FMF Connect. 

We also plan to oversample male participants (up to 20%, and then randomize any remaining 
with the rest of the sample after that). 
Families will be told in the consent document that they will be informed about future trials if they are 
not selected for the feasibility trial.
6.
INCLUSION AND EXCLUSION CRITERIA
Inclusion criteria: 

Biological parent or other primary caregiver (e.g., foster or adoptive parent, relative, legal 
guardian) of a child with FASD or PAE

The parent/caregiver must be at least 18 years old

The child must between the ages of 3 and 12 years old (if there is more than one child in the 
family with FASD/PAE in this age range, the parent/caregiver is instructed during screening 
to choose one to complete study surveys about) 

The child has a diagnosis of FASD or has confirmed PAE

The child has lived with the parent/caregiver for at least 4 months and is expected to remain 
in the home for at least 1 year

The parent/caregiver lives in the United States

The parent/caregiver has a smartphone with iOS or Android operating system
Exclusion criteria: 

The parent/caregiver is not fluent in English (the FMF Connect app and pre-post measures 
are currently only available in English)

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
There is another parent/caregiver of the same child or living in the home that is already 
enrolled in the study (couples are excluded to prevent dependence in the data)

The family has previously received or is currently receiving the therapist-led Families 
Moving Forward (FMF) Program
7.
RECRUITMENT METHODS
Potential participants will be recruited through a variety of mechanisms, consistent with previous 
studies in our research group and in CIFASD. The Study Website (www.fmfconnect.com) will 
include information about the study, as well as a link to the study REDCap Consenting and Screening 
Module for interested families to enroll. 
Information about the study will be disseminated in various ways (see study flyer with link to the 
Study Website): 

Dr. Petrenko may share study information with eligible families in the RSRB-approved 
Future Contact Database (RSRB00055352; PI: Petrenko)

Dr. Petrenko will share study recruitment materials with providers and community advocates 
who regularly see children with FASD

CIFASD investigators can inform research participants or patients in their local sites or 
clinics for which they have routine access

The National Organization on Fetal Alcohol Syndrome (NOFAS) 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  

Dr. Petrenko and other CIFASD investigators may include slides about the study in 
conference or community presentations

Organizers/moderators of popular social media groups can be sent the study flyer and can 
choose to share with their members 
As part of CIFASD, we will also try to aid other projects with recruitment from our study sample. 
Our Consenting and Screening Module includes a question asking if participants are interested in 
learning about other studies. For those that indicate yes, we will send them any new relevant flyers or 
information about other consortium projects they might be eligible for. We will submit any flyers and 
email language in a modification to this study prior to sending to our participants. For example, the 
DiG Human Genetics Study within CIFASD has previously referred some families to our study. We 
would like to send their study flyers (see attached flyer and email language) to participants in our 
sample who indicated they have not previously done the DiG study (in Screening Module).  
8.
CONSENT PROCESS
Interested parents/caregivers will go to the Study Website to begin the informed consent process. On 
the Study Website they will select the link that they are interested in participating. This link will take 
them to the study REDCap Consenting and Screening Module, hosted at UR. Interested participants 
will have the option to review study consent information by video or text.  They are also told they can 
contact the study team by phone or email to complete the consent process over the phone/video chat if 
they prefer (the research team would send them the consent and then go over it by phone/HIPAA-
compliant video chat; participant would return signed copy).
Text option: the text of the Consent document will be presented on the screen for potential 
participants to read. The Consent document will include the HIPAA authorization. 
Video option: the animated video reviews key details from the Consent document. The HIPAA 
authorization, and information about email and texting the research team are presented 

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following the video in text. 
For either option, participants will need to answer several questions about the study to ensure 
comprehension. Participants will also be asked to indicate if they have questions and space will be 
provided for them to type in any questions they have. If the participant selects “yes” they have 
questions, they will be informed the study coordinator will contact them before they proceed. The 
study coordinator’s contact information will also be presented if participants want to contact the 
coordinator with questions while reading the document. 
If they don’t have questions or the coordinator has addressed them, participants can sign the consent 
form by utilizing REDCap’s signature field. Questions asking for first and last name and date of birth 
are included as extra documentation of the participant’s identity. They participant 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 consent 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 the IP address of the participant 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 participants or printed/sent to participants in the mail on request if they 
are unable to open or save a copy electronically on their device. 
Completion of the study consent document also triggers an automatic notification to the study 
coordinator, who will log-in to REDCap and review the consent. She will document the date of this 
review in the study database. 
After completing the consent document, participants will 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, outside the US, no smartphone, etc), parents/caregivers will be informed immediately that they 
aren’t eligible and the module will end. For parents/caregivers who appear to meet criteria or in cases 
where parents/caregivers answer “unsure” for any of the questions, contact information will then be 
gathered. Contact information will also include necessary variables to generate their “globally unique 
identifier” (GUID), which is used in other CIFASD studies (https://nda.nih.gov/s/guid/nda-
guid.html).
Common variables are used across several CIFASD studies. We have adapted and streamlined several 
CIFASD Common Forms for the purposes of this study, which will be administered next in REDCap. 
These forms include: the Parent Demographic Form, the Child Demographic Form, the Prenatal 
Exposure History, and the FASD Diagnosis History forms. These forms take about 15 minutes or less 
to complete in total. 
Some interested parents/caregivers may have already completed the CIFASD Common Forms 
through another CIFASD study. To reduce participant burden, participants will be asked prior to 
completing forms if they have done any of the other current CIFASD studies. If they answer yes, 
REDCap will be set up to have them skip out on completing the Prenatal Exposure History and FASD 
Diagnosis History forms. The CIFASD Common Forms for that participant can then be located in the 
CIFASD Central Repository by their GUID.  In the event that a participant answers “yes” to other 
CIFASD studies, but their data cannot be located (e.g., is not deposited yet, difficulties creating a 

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GUID due to inconsistent data across studies), we will send participants our forms to complete via 
REDCap. Logistically, this may require changing their imputed response to “no” to release the forms 
in REDCap; this change will be documented to file.  
After completing the Consenting and Screening module, participants will be notified that project staff 
will review all submitted information to assess final eligibility. They will also be reminded of the 
randomization procedures if interest in the study enrollment exceeds targeted sample size. 
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 form.
9.
STUDY PROCEDURES
Data Collection Procedures
Parents/caregivers who are selected for the study will be sent an email inviting them to complete the 
baseline study surveys (see survey battery below) administered by REDCap. Any families not 
selected (either due to ineligibility or not enough available slots) will be informed of their status. 
Eligible families not selected will also be told that they will be notified when any subsequent 
intervention trials of FMF Connect are initiated. They can consider at that time if they might like to 
participate. 
Once the baseline surveys are completed, parents/caregivers will receive instructions via email of 
how to install the FMF Connect app on their phones (see instruction documents and accompanying 
emails). After three months, parents/caregivers will receive an email with a link to the follow-up 
surveys (see survey battery below). The assessment battery is estimated to take 35-45 minutes to 
complete at each timepoint. 
Table 1. Quantitative Study Battery
Measure
Baseline
Follow-up
Eyberg Child Behavior Inventory (5-8min)
X
X
Parenting Sense of Competence Scale (3-5min)
X
X
Family Needs Questionnaire (3-5min)
X
X
Knowledge & Advocacy Questionnaire (15-20min)
X
X
Self-Care and Support Assessment (3-5min)
X
X
Adverse Childhood Experiences (2 min)
X
Family Background & Services Survey (5-10min)
X
X
COVID-19 Experiences Survey (5 min)
X
User Version of the Mobile Health Application Rating Scale (5-8min)
X
Given lower response rates, participants who do not complete the follow-up surveys after receiving 
the automatic reminders in REDCap will be asked if they are willing to just complete the COVID-19 
Experiences Survey. This will provide important data to help us understand how much COVID-19 
impacted app usage and study engagement. This will also inform the future RCT design and 
measurement. 
A subsample of participants (up to 30 parents/caregivers) will be invited to complete an individual 
interview or focus group after completion of the 3-month follow-up assessment. These participants 
will be selected based on diverse patterns of app usage and other participant characteristics. 
The questioning route for interviews/focus groups will cover the following topics: 1) overall 

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impressions of the FMF Connect app; 2) experience using the app (both facilitators and barriers of 
use); 3) satisfaction and feedback on individual components of FMF Connect; and 4) perceived 
impact on self and family. Interviews/focus groups are expected to take about 60-90 minutes each. 
Audio recordings of interviews/focus groups will be transcribed for later analysis.
FMF Connect mHealth Intervention
The FMF Connect intervention includes cloud infrastructure and an innovative, multilayered mobile 
app. It incorporates tailored content for parents/caregivers of children (ages 3-12) with FASD or PAE. 
The app integrates five main components: 1) Dashboard; 2) Learning Modules; 3) Family Forum; 4) 
Library; and 5) Notebook. Weekly emails are also sent to support motivational engagement. 
App education, derived from the standard FMF Program, is packaged in easily digestible Learning 
Modules. The Learning Modules are organized into three levels: 1) Getting Started; 2) Taking Action; 
and 3) Taking It to the Next Level. Each level is presented incrementally, with content in the 
subsequent level being made accessible once core content from the prior level has been viewed. The 
Library provides access to additional optional content that can be downloaded and printed to use in 
advocacy and skill development. The Notebook is a personalized section that organizes 
parents’/caregivers’ responses to learning activities in a convenient location for later easy access. 
The Family Forum serves to 1) engage and facilitate parents’/caregivers’ continued utilization of the 
app, 2) support and extend parents’/caregivers’ implementation of new knowledge and skills, and 3) 
provides peer support, encouragement, and understanding of the parent’s/caregiver’s own needs. 
Trained peer moderators will moderate discussion in family forums to ensure safety. They will also 
provide support and prompt skills or content areas to consider. 
The Dashboard displays parent/caregiver progress in Learning Module completion, use of the Family 
Forum, and daily and weekly ratings imputed by the parent/caregiver. It also includes the Tip of the 
Day feature. 
Complementing the app is a Cloud infrastructure to transparently but securely distribute information, 
including storing and retrieving data, managing notification and messaging, and synchronizing data 
on all devices. A local datastore will protect the mobile app 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. Updates 
will be automatically pushed out so users have the latest version. 
10. AUDIO/VIDEO RECORDINGS 
Qualitative interviews will be recorded using the HIPAA-complaint Zoom videoconference 
application hosted by UR. Zoom allows users to join with audio and/or video using their computer 
and/or their phone. Audio and video recordings are downloaded immediately following the interview 
and saved to the secure servers at MHFC or UR supported Box (UR Zoom settings do not provide 
storage; they can only be saved locally). Only project staff will have access to these recordings. 
Recordings will be maintained indefinitely.  
 
11. RISKS TO SUBJECTS
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. Psychological 
discomfort is also possible during interactions between participants as part of the Family Forum of 
the FMF Connect app. This potential risk of discomfort is expected to be similar to other social 
media use. 

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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. The Peer Moderators in the Family Form will be trained to 
promptly alert Dr. Petrenko if there are concerns about a participant or their family’s well-being so 
she can take appropriate steps, which may include alerting outside authorities to ensure safety. It is 
also possible that other parents/caregivers in the Family Forum might disclose personal information 
about other participants who post in the Forum to people outside of the research studies. 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 during surveys and interviews, 
participants will be given the option to skip questions they feel uncomfortable answering. The Peer 
Moderators in Family Forum will be trained in creating a welcoming, nonjudgmental, and supportive 
environment for all participants. Clear rules and expectations will be delineated for the Peer 
Moderators and participants. Participants will be notified of these rules and expectations upon 
receiving the FMF Connect app and will be reminded throughout their participation. Any violations 
of these rules and expectations will be addressed by the Peer Moderators (e.g., removing posts, 
alerting Dr. Petrenko). These violations will also be reviewed by Dr. Petrenko during supervision 
with the Peer Moderators. Participants will also have the ability to send an email to project staff if 
they experience discomfort during their participation in the Family Forum. Appropriate actions will 
be taken under Dr. Petrenko’s supervision to address discomfort and participant well-being and 
safety. Participants can also choose to not enter or post in the Family Forum if they do not feel 
comfortable or are not interested in this component. 
Multiple procedures will be implemented to protect participant confidentiality. In terms of data 
storage and management, all hard copy data (e.g., notes during qualitative interviews), will be 
secured in locked file cabinets within locked offices, available only to program staff. Electronic data 
(e.g., digital audio recordings and transcripts from interviews) will be stored in secured servers, and 
only program staff with knowledge of the password will be able to access the data. Forms with 
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). These were built and are managed by Dr. Tapparello. As a result, users will be able to add 
and modify their own data but will be prevented from viewing and modifying other users' data. FMF 
Connect 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 FMF Connect 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 

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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 and the Peer Moderators 
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. If 
maltreatment is suspected, staff will first discuss their concerns with the caregiver and inform 
him/her that, as indicated in the consent form that she/he had previously signed, our staff are 
ethically and legally obligated to file a report with Child Protective Services. We have found that 
this approach conveys respect for the family and mitigates parental anger that might otherwise 
emanate from filing a report. In our experience, when situations requiring filing a maltreatment 
report are handled sensitively and framed as stemming from concern for the welfare of the entire 
family, caregivers often perceive the process as being helpful to them. 
Finally, while it is not possible to control what participants do outside of group settings (e.g., Family 
Forum), we will thoroughly explain the concept and importance of confidentiality and give real life 
examples of what is appropriate and inappropriate to discuss with people outside of the project. The 
Peer Moderators will emphasize the importance of confidentiality and will monitor and remind 
families of this rule and expectation. Privacy settings within the Family Forum will balance 
participant confidentiality and caregiver preferences. All caregivers will be assigned a unique 
username to log into the app. They will also be able to select their own username that will show up in 
the Family Forum, which does not contain personal identifying information. These usernames will be 
separate from their research participant ID numbers. Participants will be informed of the risks to 
confidentiality at the outset of the study and will be provided with reminders. Caregivers will have the 
ability to choose how much information to share about themselves and their experiences in the Family 
Forum. No other data from other app components will be shared in the Forum, unless the caregiver 
independently and voluntarily elects to do so. 
The FMF Connect intervention 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
Parents and caregivers 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 children and families. It is also possible, 
although not guaranteed, that participants might derive benefit from receiving the FMF Connect 
program. Possible benefits may include increased knowledge about FASD and parenting strategies or 
social support from other caregivers. 
13. COSTS FOR PARTICIPATION
There are no costs to participate. 
14. PAYMENT FOR PARTICIPATION 
Parents/caregivers will receive a $40 electronic gift card each time after completing the baseline and 
follow-up surveys. If selected, parents/caregivers will receive $20 for completing a qualitative 
interview. 
Participants who did not complete the follow-up survey battery, but were willing to complete the 
COVID-19 Experiences Survey will receive a $5 gift card. 
15. SUBJECT WITHDRAWALS

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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 app as much as they want (or not at all). 
We are interested in obtaining pre-post 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, secure data servers at MHFC, Project REDCap database, and an encrypted, HIPAA-
complaint Cloud database (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. Multiple procedures 
will be implemented to protect participant data collected through the app, which are further detailed 
in the section “Protections Against Risks.” Participant user names in the app will not include 
personally identifying information and will be distinct from their research subject number. Only 
senior key personnel and project research staff will have access to the data.
Written transcripts of qualitative data will omit any identifying information provided by participants 
during audio recorded interviews. For publication, any quotes utilized to provide evidence for a 
theme will be de-identified. Findings will be discussed in aggregate. 
Consistent with the mission of CIFASD, the CIFASD Data Repository allows for data sharing for 
internal CIFASD investigators across projects as well approved external investigators. A CIFASD 
Data Sharing Policy has been established and is available on the CIFASD website: 
https://cifasd.org/data-sharing/. External investigators need to submit a CIFASD Data Access 
Request Form, CIFASD Data Use Agreement, and provide documentation of IRB approval. 
17. DATA / SAMPLE STORAGE FOR FUTURE USE
As a CIFASD project, de-identified data from this project will be stored indefinitely in the CIFASD 
Central Repository, as required by CIFASD and NIAAA. The Central Repository is hosted and 
managed at Indiana University. Policies and procedures associated with the CIFASD Central 
repository are described in the prior section. Also, since data are associated with a GUID they can be 
aggregated with other studies with overlapping participants.
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 families who participated in this research. Retaining identifying 
information would facilitate contacting families (subsequent to new IRB approval) to see if they 
would be interested in participating in follow-up research. MHFC has well-establish data security 
procedures in place for long-term storage and maintenance of data. Only approved project staff will 
have access to data. 
18. DATA AND SAFETY MONITORING PLAN
Because the research involves the provision of a mobile health parenting intervention for parents and 
caregivers, the risk for a serious adverse event due to provision of the intervention is low. Adverse 
events that could occur in children with FASD or their parents/caregivers 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 

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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 pilot feasibility studies 
with children and teens with FASD and their families. She is a licensed psychologist in the state 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. 
The Peer Moderators will be trained to contact Dr. Petrenko immediately about any significant 
concerns that arise during their interactions with participants in the Family Forum. 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 the Peer Moderators. Dr. Petrenko will meet with the Peer 
Moderators weekly during the feasibility test 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
Fred 
Rogosch, 
Ph.D.
Research Director & Senior 
Research Associate, Mt. Hope 
Family Center, University of 
Rochester
Clinical psychologist; developmental 
psychopathology; risk and resilience factors; 
child maltreatment; long-standing member 
of UR Research Subjects Review Board; has 
served on prior DSMBs for high risk studies 
at MHFC
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, 
Clinical psychologist; suicide prevention; 
public health messaging; safe and ethical use 
of technology in prevention science

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University of Rochester 
Medical Center
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 “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 children and their families. 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. The FMF Connect app will also contain 
a module with links for mental health and crisis resources, as an additional safeguard. A safety 
message will also be included in the app to direct caregivers to call 9-1-1 or other local crisis services 
in the event of an emergency. 
19. DATA ANALYSIS PLAN
Aim 1: Pilot the Pre-Post Assessment Battery and Estimate Intervention Effect Sizes 
Descriptive statistics and reliability indices will be calculated for all measures at each time point. 
Analysis of Variance (ANOVA) techniques and effect size calculations will be used to estimate the 
magnitude of intervention effects. These analyses will inform power analyses for the future large-
scale RCT and refinement of the measurement battery. 
Additional correlational and regression analyses will also be undertaken to get a preliminary sense of 
how outcomes relate to patterns of app usage. 
Aim 2: Evaluate the Feasibility and User Satisfaction with FMF Connect
Transcripts from qualitative interviews completed with selected parents/caregivers 3-months after 
accessing the FMF Connect app will be analyzed thematically [14] to understand their experiences 
using the app intervention. Specifically, ‘first-level coding’ will be undertaken by members of the 
research team to identify key ideas and common themes expressed by parents/caregivers. Identified 
themes will then be discussed and operational definitions determined. ‘Second-level codes’ are 
generated and a preliminary thematic framework is established. Interviews are then independently 
recoded to assess fit with the framework and identify confirmatory and disconfirmatory evidence for 
the model. Matrices are also often utilized to systematically examine relationships among constructs 
or assess model fit across participants. Agreement among team members on the analytic model is 
iteratively assessed and discrepancies resolved through further discussion, model refinement, and 
consensus. These analyses will inform app fine-tuning prior to the large-scale RCT planned in phase 
3.
20. REFERENCES
[1] 
S. N. Mattson, N. Crocker and T. T. Nguyen, "Fetal alcohol spectrum disorders: neuropsychological 
and behavioral features.," Neuropsychology review, vol. 21, no. 2, pp. 81-101, 2011. 
[2] 
S. J. Astley, "Profile of the first 1,400 patients receiving diagnostic evaluations for fetal alcohol 
spectrum disorder at the Washington State Fetal Alcohol Syndrome Diagnostic & Prevention 
Network," The Canadian Journal of Clinical Pharmacology, vol. 17, no. 1, p. e132–64, 2010. 

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[3] 
C. L. M. Petrenko, "Positive behavioral interventions and family support for fetal alcohol spectrum 
disorders.," Current Developmental Disorders Reports, vol. 2, pp. 199-209, 2015. PMC ID: 
PMC4569135. 
[4] 
C. L. M. Petrenko, N. Tahir, E. C. Mahoney and N. P. Chin, "A qualitative assessment of program 
characteristics for preventing secondary conditions in individuals with fetal alcohol spectrum 
disorders.," Journal of Population Therapeutics and Clinical Pharmacology, vol. 21, pp. e246-e259, 
2014. PMCID: PMC4138539
[5] 
C. L. M. Petrenko, N. Tahir, E. C. Mahoney and N. P. Chin, "Prevention of secondary conditions in 
fetal alcohol spectrum disorders: Identification of systems-level barriers," Maternal and Child 
Health Journal, vol. 18, pp. 1496-505, 2014. PMCID: PMC4007413
[6] 
D. M. Ryan, D. M. Bonnett and C. B. Gass, "Sobering thoughts: town hall meetings on fetal alcohol 
spectrum disorders," American Journal of Public Health, vol. 96, pp. 2098-2101, 2006. 
[7] 
C. L. M. Petrenko, M. E. Alto, A. R. French and S. M. Freeze, "’You have to fight for your child’: 
foster and adoptive parents’ experiences raising a child with FASD in the context of the 
development of secondary conditions," submitted. 
[8] 
J. Bertrand, "Interventions for children with fetal alcohol spectrum disorders (FASDs): Overview of 
findings for five innovative research projects," Research in developmental disabilities, vol. 30, no. 
5, pp. 986-1006, 2009. 
[9] 
H. C. Olson and J. Sparrow, "Using Positive Behavior Support Techniques with Families: Fetal 
Alcohol Spectrum Disorders Intervention," in The Expanding World of PBS: Science, Values and 
Vision. 13th International Conference on Positive Behavior Support, San Francisco, CA. 
[10] C. L. M. Petrenko, M. E. Pandolfino and R. L. K, "Findings from the Families on Track preventive 
intervention pilot trial with children with FASD and their families," submitted. 
[11] C. Tapparello, W. Heinzelman, K. Conn and C. A. Mullen, "ManageMyCondition: A Standard 
Framework for the Development of Cloud-based Medical Condition Management Applications," in 
IEEE International Workshop on Cloud Connected Health (CCH), Washington D.C., 2016. 
[12] Apple, "ResearchKit," 03 2015. [Online]. Available: http://researchkit.org.
[13] 
[14]
Apple, "CareKit," 04 2016. [Online]. Available: http://carekit.org.
M. B. Miles, A. M. Huberman and J. Saldana, Qualitative data analysis: A methods sourcebook, 
third edition, Los Angeles, CA: SAGE Publications Inc, 2014.