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

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Efficacy 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 third 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 primary focus of the FMF Connect app is to provide 
parent/caregiver education and support. 
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 developed in both iOS and Android and beta-testing was completed with 
parents/caregivers and providers.  In the second phase of the study, we conducted a feasibility trial of 
the FMF Connect app with  parents/caregivers under IRB protocol #4433. This included quantitative 
pre-post surveys and qualitative interviews with a subsample of users to optimize the intervention and 
trial procedures. In this third phase, we will conduct a larger scale randomized controlled trial (RCT) 
to test the efficacy of the FMF Connect app for parents/caregivers of children with FASD. We 
hypothesize that participants who receive the FMF Connect app (with or without the additional 
Coaching Module) will have improve outcomes relative to the waitlist control group. We anticipate 
the Coaching Module will increase participant engagement and usage of the FMF Connect app. 
Finally, we hypothesize that parental attributions of behavior targeted by the FMF Connect app will 
mediate intervention effects on child behavior and parenting self-efficacy. 
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 
difficult to evaluate the credibility and effectiveness of information provided through these 
modalities. 

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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,” is 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 follows a systematic approach to the development and evaluation of the FMF Connect 
mHealth intervention. The app is designed for use by caregivers, utilizes a cloud-based infrastructure, 
and builds on our existing open source framework for the development of medical apps [11], and 
those of others [12,13]. Feasibility tests and iterative feedback from diverse caregivers have aided in 
fine tuning caregiver instructions, content, and user-interface features throughout the development 
process. 
The proposed RCT will establish the efficacy of the FMF Connect mHealth intervention in a large-
scale efficacy trial. It will also assess the patterns of app usage that relate to the greatest 
improvements in child and caregiver outcomes and test whether text-based coaching increases 
engagement with the app. 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. 
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). 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
This study involves a three arm RCT with equal allocation to the following conditions: (1) FMF 
Connect + coaching, (2) FMF Connect alone, and (3) waitlist control. Quantitative survey data will be 
collected at three timepoints: baseline (T1), 6-weeks (T2), and 12-weeks (T3). The T2 timepoint will 
involve an abbreviated battery designed to allow statistical tests of mediation hypotheses (see Data 
Analysis Plan below). Primary study outcomes include child behavior, parent FASD knowledge, 

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parenting self-efficacy, behavior attributions, family needs met, and parent use of self-care. We are 
also interested in participant ratings of app quality and patterns of app usage. App usage will be 
recorded through AWS during the study period. After T3, study participants in the waitlist control 
group will receive the FMF Connect app. 
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 150 parents or caregivers with usable data in this study to achieve adequate 
power for study aims (see data analysis section below). We expect a portion of families will enroll in 
the study, but not complete assessments or install the app. Based on our feasibility trial, 57% of 
participants who initiated screening were eligible for the study and had complete data. This 
percentage may be a bit lower than we can achieve for the proposed RCT given that the COVID-19 
pandemic began right after the initiation of the feasibility trial and affected participation. We also 
identified some inefficiencies in our enrollment process that we can improve to reduce incomplete 
data. Of eligible families selected for the study, we expect about 85% of eligible families to complete 
baseline surveys. Of these families, about 80% are likely to install and use the app at least once. To 
attain our desired sample size, we will aim to enroll about 300 parents and caregivers. 
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 or ipad with iOS 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)

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 parent/caregiver participated in a prior trial of the FMF Connect app as part of phase 1 or 
2 of this project. 

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 will include information about the 
study, as well as a link to the study REDCap Consenting and Screening Module for interested 
families to enroll. 

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The following materials have been developed to aid with recruitment: (1) study flyers, (2) social 
media banners formatted for Facebook, Twitter, and Instagram, and (3) powerpoint slide. Information 
about the study will be disseminated in various ways: 

Dr. Petrenko will share study recruitment materials with providers and community advocates 
who regularly see children with FASD

We will post study information on our study Twitter account (@FMFConnect) and newsletter 
(www.fmfconnect.com) 

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 recruitment materials 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 
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. The study coordinator will document contact 
in the study contact log in REDCap. 

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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. The 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. 
After completing the consent document, 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, 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. After completing the Consenting and Screening module, participants will be 
notified that project staff will review all submitted information to assess final eligibility. 
Participant 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 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 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. See next 
section. 
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 & Randomization Procedures
Parents/caregivers who are eligible for the study will be sent an email inviting them to complete the 
baseline study surveys (see survey battery below) administered by REDCap. Participants will be 

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asked to enter their zip code to verify their identity when completing baseline and follow-up surveys 
(this will be verified against value entered in demographic surveys in the screening module). Families 
deemed ineligible after detailed review will be informed of their status. 
Following baseline survey completion, participants will be randomized to one of three arms of the 
RCT: 
1.
FMF Connect app + text based coaching (within the app)
2.
FMF Connect app (without coaching)
3.
Waitlist control 
Randomization will occur through the REDCap Randomization module, with an equal allocation 
pattern across groups. Participants will be notified of their group status via email. Emails for 
parents/caregivers in either of the FMF Connect app intervention groups (groups 1 and 2) will also 
include instructions of how to install the FMF Connect app on their devices. The email for the 
parents/caregivers in the FMF Connect app + coaching group (group 1) will inform them that they 
will receive an introductory email from their assigned coach in the next few days. Details about the 
FMF Connect app and Coaching interventions and described below. 
All participants regardless of group assignment will receive emails through REDCap at 6 weeks and 
12 weeks inviting them to complete follow-up surveys, along with a personalized link (see survey 
battery below). The assessment battery is estimated to take 35-45 minutes to complete at T1 and T3; 
T2 is estimated at 15-20 min. Waitlist control participants will receive the FMF Connect app 
following T3 survey completion. 
Table 1. Study Assessment Battery
Measure
Baseline 
(T1)
6-Weeks 
(T2)
12-Weeks 
(T3)
Eyberg Child Behavior Inventory (5-8min)
X
X
Reasons for Children’s Behavior Scale (4-6min)
X
X
X
Everyday Life Scale (4-6min)
X
X
X
Parenting Sense of Competence Scale (3-5min)
X
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
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. 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 

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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. 
The primary purpose of FMF Connect is to provide parent/caregiver education and support. It does 
not meet the FDA’s definition of a medical device; it is not aiming to cure, treat, mitigate, or prevent 
FASD and is most similar to apps within the General Wellness category. 
Coaching Module
On average, about 25% of apps are only used once after download [14], and only 29% of app users 
were still using an app 90 days after download [15]. A Coaching Module has been developed within 
the FMF Connect app to help engage parents/caregivers and support continued use and individualized 
goal setting within the app. 
The Coaching Module will be activated for parents/caregivers in the FMF Connect + Coaching group 
only. This Module will allow their assigned coach to exchange text-based messages through the FMF 
Connect app’s notification system with them. Coaches will have access to a dashboard of their 
participants’ progress and use of the app, which will aid in tailoring messages and supporting parents 
in their identified goals. The Coach’s interface also provides a secure way to provide text-based 
messages to the participant within the app. 
Coaches include research staff and graduate students on the project who are familiar with the FMF 
Program principles and are knowledgeable about FMF Connect content and features. They have 
training in motivational interviewing (MI), which is a key therapeutic technique used in the FMF 
Program. Coaches will use the spirit and skills of MI to elicit the participant’s own motivation to 
learn more about FASD and skills taught in FMF Connect. They will help align the 
parent’s/caregiver’s own values and goals with the content and features within FMF Connect. 
10. 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 Coaches and 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, 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, any hard copy data will be secured in locked file cabinets within locked 
offices, available only to program staff. Electronic data 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 
research staff. Participants will be told about all exceptions (e.g., child/dependent adult abuse, harm 

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to self or others) to confidentiality during the consent process. Project staff (which includes 
Coaches) 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. 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. 
11. 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. 
12. COSTS FOR PARTICIPATION
There are no costs to participate. 
13. PAYMENT FOR PARTICIPATION 
Eligible parents/caregivers will receive a reloadable gift card associated with the Advarra system. 
They will receive $40 on the gift card for completing T1 and T3 surveys, and a $20 for completing 
the briefer T2 surveys. 
14. 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 

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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. 
15. 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.” Only senior key personnel and project research staff will 
have access to the data.
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-established 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 
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.  

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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. 
Coaches and Peer Moderators will be trained to contact Dr. Petrenko immediately about any 
significant concerns that arise during their interactions with participants in the app. 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 Coaches and Peer Moderators. Dr. Petrenko will meet with 
Coaches weekly to provide supervision and will assess participant well-being. Dr. Petrenko will also 
provide supervision to Peer Moderators; the frequency of these meetings will depend on the activity 
level with the Family Forum (during prior beta-test and feasibility trials some weeks had only a few 
new posts), but will occur at minimum every 3 weeks. 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 “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.

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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: For the two intervention groups, compare patterns of app usage (i.e., frequency, 
duration, use of core components) that relate to greater improvements in child and caregiver 
outcomes. Assess whether FMF Connect + Coaching results in higher usage of the app relative 
to FMF Connect alone. 
A series of Multiple Regression analyses will test how app usage (i.e., frequency, duration, 
content/components accessed) relates to change in outcomes (i.e., parenting efficacy, FASD 
knowledge, family needs, child behavior) over time, controlling for pre-intervention level of 
functioning. With a sample size of 100 (n=50 per intervention group) and assuming α = .05, there will 
be power .80 to detect small/medium effects (f2=.10), .94 to detect medium effects (f2=.15), and 
power > .99 to detect large effects (f2=.35).  
Aim 2: Examine whether families randomized to the three study arms differ in outcomes. 
Repeated Measures Analysis of Variance will test whether families randomized to FMF Connect 
groups demonstrate improved outcomes relative to the waitlist group at 12 weeks. Pairwise 
comparisons will test for differences among intervention groups to determine if coaching adds 
additional benefit. Assuming a correlation among repeated measures ranging from .3 to .5 (α = .05), 
with a sample of 150 and 3 time points, there will be power between .87-.96 to detect a small/medium 
effect (f=.175) and >.99 to detect medium and large effects (f=.25 and f=.40). 
Aim 3: Examine whether parental attributions of child misbehavior mediate intervention-
related changes in parenting efficacy and child behavior.
Mediation analyses will test whether parental attribution mediates the effects of FMF Connect on 
parenting efficacy and child behavior, including baseline levels of the respective outcomes. Given a 
sample size of 150, there will be adequate power (>.80) to detect small/medium effects within the 
mediation models using the bias-corrected bootstrap method.
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. 
[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 

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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.
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Apple, "CareKit," 04 2016. [Online]. Available: http://carekit.org.
Statista Research Department. 2021. Percentage of mobile apps that have been used only once from 
2010 to 2019. https://www.statista.com/statistics/271628/percentage-of-apps-used-once-in-the-us/
Localytics, 2017. Overall App Benchmarks H2 2017. 
https://uplandsoftware.com/localytics/resources/cheat-sheet/overall-app-benchmarks-h2-2017/