Pilot Trial of the FMF Connect Teacher Companion Website
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Sponsor: University of Rochester

COVER PAGE 
 
STUDY TITLE: Study of the Families Moving Forward Website Behavioral Intervention for 
Teachers of Students With Fetal Alcohol Spectrum Disorder 
 
 
 
 
NCT05986565 
 
 
 
 
DOCUMENT DATE: 10/24/2023 

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Pilot Trial of the FMF Connect Teacher Companion Website
Principal Investigators – Christie Petrenko and Cristiano Tapparello
1. PURPOSE OF STUDY 
The purpose of this study is to evaluate feasibility of the FMF Connect Teacher Companion 
website and study design through a pilot trial. Specifically, we will investigate 1) intervention 
feasibility and 2) study design acceptability. Intervention feasibility includes technological 
feasibility of the website, acceptability of the website, and typical usage patterns. Study design 
acceptability includes enrollment and attrition rates, acceptability of randomization and control 
condition, assessment acceptability and sensitivity, optimal intervention length, and predictors of 
attrition.
Our hypotheses are:
1) the website will be technologically functional and acceptable to users, and users will show a 
moderate level of engagement with the website as evidenced by at least one hour per week of 
use.
2) the study design and assessments will be acceptable, the study will have sufficient enrollment 
to meet recruitment targets, and attrition will be predicted by teacher type (general education 
teacher) and teacher level of experience with FASD (teachers with less experience will be more 
likely to remain in the study).
This study is a pilot trial. Pilot trials are indicated when there is little information using a specific 
intervention technique in a certain population or the target population has been shown to need 
unique consideration of the topic (Bowen et al., 2009). 
2. BACKGROUND AND RATIONALE 
Fetal alcohol spectrum disorders (FASD) affect an estimated 1.1-5% of children in the 
US (May et al., 2018) and can impact various aspects of neurodevelopment, including executive 
functioning, behavior, and academic performance. Although the majority of individuals with 
FASD are not intellectually disabled (Mattson et al., 2011), children with FASD perform lower 
than nonexposed individuals in academics (Crocker et al., 2015; Glass, 2016; Howell et al., 
2006; Jirikowic et al., 2008). Without appropriate support, deficits in executive functioning and 
self-regulation may lead to difficulty organizing materials, planning, and sustaining attention as 
well as emotional and behavioral dysregulation. Teachers often lack understanding of FASD, 
leading to ineffective strategies and frustration. Lack of awareness and insufficient training on 
FASD in the school system creates significant barriers to services for children with FASD 
(Dybdahl & Ryan, 2009; Koren et al., 2010; Millar et al., 2017; Ryan & Ferguson, 2006; Ryan et 
al., 2006). Parents often report struggling to obtain services and supports for their children in 
schools and describe having to educate teachers and staff about FASD (Petrenko et al., 2014; 
Petrenko et al., 2020; Ryan & Ferguson, 2006; Ryan et al., 2006). 
In-person trainings are limited in reach, while a digital intervention delivered via the 
internet can provide broader access and flexibility. The Families Moving Forward (FMF) 
Program is a scientifically-validated behavioral consultation program developed at Seattle 
Children’s Research Institute/University of Washington by Heather Carmichael Olson and 
colleagues (Bertrand, 2009; Olson & Montague, 2011; Petrenko et al., 2017). It is usually 
delivered in person or via telehealth by trained specialists. It is designed for caregivers of 

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children with FASD and includes an in-person, targeted school consultation in which a specialist 
works with school staff to educate them on FASD, build a more positive home-school 
relationship, and discuss ways to better support the student. Educating teachers to increase their 
knowledge and awareness of FASD is hypothesized to help them to modify their attributions of 
the student’s behavior and use more effective behavioral strategies, leading to improved self-
efficacy and student-teacher relationship. 
Given lack of widespread awareness of FASD, stigma. and numerous systems barriers 
(Petrenko et al., 2014; Roozen et al., 2020), many families in need of evidence-based 
intervention do not receive it. To address this need, the FMF Connect mobile Health (mHealth) 
app was derived from the standard FMF Program to directly provide caregivers with easily 
accessible, self-directed, evidence-based content and resources. In development and initial 
feasibility trials of FMF Connect, parents stressed the importance of materials or interventions 
for teachers (Petrenko et al., 2020; 2021). The FMF Connect Teacher Companion website was 
developed using the ADAPT-ITT framework (Wingood & Clemente, 2008) to address this need. 
It includes materials and exercises from the FMF Program and FMF Connect which have been 
adapted to teachers, incorporating a teacher needs assessment and a Teacher Advisory Board.
 The current study will pilot the FMF Connect Teacher Companion website to determine 
technological acceptability and feasibility of study design and methods to inform a future RCT. 
This trial is designed using best practices in pilot/feasibility trials (Lancaster et al., 2004; 
Eldridge et al., 2016) and will follow the CONSORT extension for pilot trials in reporting and 
publishing (Eldridge et al., 2016). Aligning with the FMF model, the Teacher Companion 
website is the next logical step to disseminate this empirically-validated treatment and will 
complement FMF Connect in building a scalable and accessible network of support for children 
with FASD and their families. 
The FMF Connect Teacher Companion website will increase accessibility of evidence-based 
materials on FASD for teachers, which is particularly critical for rural and other underserved 
populations. Websites can be easily accessed across a number of platforms including a mobile 
phone, tablet, laptop, or desktop computer, necessary for teachers who may work in a variety of 
settings, and are less likely to use a mobile phone in the classroom. This increased accessibility 
will allow teachers to more successfully manage behavior and support learning of students with 
FASD and will decrease barriers to quality care and services faced by many caregivers of 
children with FASD (Petrenko et al., 2014; Roozen et al., 2020; Ryan et al., 2006). This project 
will advance scientific knowledge relating to teacher awareness, perceptions, behavioral 
strategies, and self-efficacy related to FASD. It will also address a need for a systematically 
developed intervention which can be tested and improved through rigorous and reproducible 
research. Although some teacher resource websites for FASD exist, this will be the first 
empirically-derived and tested digital teacher intervention specific to FASD.
3. ADMINISTRATIVE ORGANIZATION  
This study is led by Drs. Christie Petrenko and Cristiano Tapparello. Dr. Petrenko is faculty at 
Mt. Hope Family Center and has appointments in the departments of Psychology and Pediatrics. 
Dr. Tapparello is faculty in the department of Electrical and Computer Engineering. They will 
oversee all research staff, implementation of human subjects’ protections, and data collection, 
management, analysis, and reporting. 
All data collection will be through our research team at the University of Rochester. Participants 

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will be recruited online and complete informed consent, screening, and survey through our 
REDCap database, hosted at the University of Rochester. Interview data will be collected via 
HIPAA-complaint Zoom. Additional data will be collected through the FMF Connect Teacher 
Companion website, developed and managed by our team and hosted on a URMC-managed 
Azure account.
4. STUDY DESIGN
The study design is a 2-parallel arm, staggered design pilot RCT. All subjects will complete 
baseline assessments. Then they will be randomly assigned to either Group 1) Website, or Group 
2) Delayed treatment control. Group 1 will receive access to the website immediately. After six 
weeks, both groups will complete Timepoint 2 assessments. Selected participants will complete a 
qualitative interview about their experience using the website. After completion of Timepoint 2 
assessments, Group 2 will receive access to the website (Group 1 will retain access to the 
website). After an additional six weeks, both groups will complete Timepoint 3 assessments and 
the study will conclude.
Assessments will include measures of FASD knowledge, teacher self-efficacy, teacher 
attributions and behavioral strategies, and satisfaction with the technology and study. Website 
usage data will be collected using Azure Application Insights (feature that can be enabled on our 
URMC-managed Azure account). Participants will be assigned to groups using simple 
randomization using manual 50/50 chance randomization.
5. SUBJECT POPULATION
The study population will be U.S. teachers of grades K-5. We will aim to enroll 90 participants 
to achieve a final sample size of 50, assuming a 45% attrition rate (consistent with recent 3-
timepoint online studies in our lab). Additional participants will be enrolled if attrition is greater 
than anticipated. 
6. INCLUSION AND EXCLUSION CRITERIA
Inclusion Criteria
Subjects must:

Be an educational professional currently actively employed in a school setting in the United 
States

Be above the age of 18 years old

Have direct, consistent contact with a student with a diagnosed fetal alcohol spectrum 
disorder (FASD) or confirmed prenatal alcohol exposure (PAE) between the ages of 5-12, 
(i.e. grades K to 5) in a special or general education classroom

Have reliable access to the Internet

Be able to consent for themselves
Exclusion criteria:
Subjects will be excluded if:

They are unable to read English

They do not have direct, consistent contact with a student with a diagnosed FASD between 
ages 5-12 (e.g., substitute teacher, principal)

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7. RECRUITMENT METHODS
Subjects will be recruited nationally through a number of sources:

In order to directly target teachers in under-resourced areas, we will identify low-
income school districts using the Teacher Cancellation Low Income (TCLI) directory. 
This directory includes schools identified as low-income for the purposes of federal 
aid. We will randomly select districts in different states from this directory and reach 
out to administrative personnel about the study. If interested and willing, they will 
send out information about the study to the teachers in the district. 

We will also recruit via parent participants involved in trials of the FMF Connect app, 
all of whom have children with confirmed PAE or FASD. Parents with a child 
between the ages of 5-12 who have consented to receiving information about future 
research will receive an email informing them about the Teacher Companion website 
trial. This email will encourage them to share recruitment materials with their child’s 
teacher for the upcoming year if interested. Teachers can then contact the study team 
if they would like to participate and will be encouraged to forward to any other 
eligible teachers. 

If these two methods do not prove adequate in recruiting sufficient and diverse 
subjects, we will target teachers and school staff through national email newsletters 
and social media forums specific to teachers. We will also send recruitment materials 
to disability- and FASD-specific networks such as the University Centers for 
Excellence in Developmental Disabilities (UCEDD) email listserv and FASD special 
interest groups. Finally, we will engage colleagues in the FASD field to send 
recruitment materials to their networks to recruit teachers who have a student with 
FASD.
8. CONSENT PROCESS
Given this research is no greater than minimal risk and involves procedures for which written 
consent is normally not required outside of the research context (e.g., survey responses, website 
usage), we are requesting a waiver of documentation of consent. There is also not an easy way to 
verify participant identify for written eConsent without creating an additional step for 
participants involving communication with research staff through another method (e.g., email, 
phone). 
Subjects who are interested in participating in the study will be directed to the REDCap 
Screening Module where they will view the Study Information Sheet. After reviewing the Study 
Information sheet, they will be asked several questions assessing their understanding of the 
information. All subjects will be given the option to download a copy of the Information Sheet 
for their records. 
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. Additional items will screen for eligibility and 
obtain contact information. 
The primary identifying information collected as part of this study are participant contact 
information in the REDCap Screening Module. This contact information would allow us to 

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contact participants in several anticipated scenarios, such as: if they indicate they have questions 
about the study, they provide inconsistent information we need to clarify, or to send them 
surveys or schedule interviews. 
Identifying information will be stored separately from other de-identified data sources. 
After reviewing the information sheet and completing comprehension questions, 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., doesn’t have a student with 
FASD), participants will be informed immediately that they aren’t eligible and the module will 
end. Screening data will be maintained for ineligible participants to aid in clinical trial reporting 
requirements (e.g., documenting numbers screening, eligible vs. ineligible, and reasons). 
This study is funded by the National Institute of Health (NIH). A Certificate of Confidentiality is 
automatically included as part of the notice of award. Language regarding the Certificate of 
Confidentiality is included in the consent documents.
Due to an increase in fraudulent participants across studies in our lab, we have developed a lab-
wide guide to prevent, detect, and systematically manage fraudulent participants (see uploaded). 
For this study, if “red flags” (e.g., common email formula, unusual emails; see lab-wide guide 
for other examples) are identified by research staff, they will follow lab scripts to withdraw the 
participant.
9. STUDY PROCEDURES    
After informed consent, participants will be asked to complete screening questions to assess for 
eligibility criteria. Subjects who are not eligible will be told immediately and the module will 
end. Subjects who are eligible will be randomized to either Group 1 (Website) or Group 2 
(Delayed Treatment Control). Randomization will be completed using manual 50/50 chance 
randomization. After randomization, subjects will complete the remaining baseline surveys (see 
details on the assessment battery below). 
Once baseline surveys are complete, subjects in Group 1 will receive immediate access to the 
website. After 6 weeks, all subjects will be re-contacted to complete timepoint 2 surveys. User 
implementation data will be gathered through the website. To further assess acceptability, 
satisfaction, and barriers and facilitators of website use, selected participants will complete 
qualitative interviews over HIPAA-complaint Zoom or telephone. Interviews will be recorded 
and later transcribed verbatim. Participants will be selected for interviews based on patterns of 
website usage, personal demographics such as race, ethnicity, job title, and years of experience, 
and school geographic setting. A total of 5 participants will be interviewed from Group 1 at 
Timepoint 2.
After completion of Timepoint 2 assessment, Group 2 will receive access to the website (Group 
1 will retain access to the website). After another six weeks, all subjects will complete Timepoint 
3 assessments. A total of 5 participants will be interviewed from Group 2 at Timepoint 3, 
selected using the same procedure as for Timepoint 2.
The study coordinator will email participants to the email they provided to inform them they 
have access to the website and alert them to their login information. 
Participants will be prompted to complete surveys upon reaching each timepoint via automated 

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invitation sent to the email they provided in REDCap. If they do not complete the surveys within 
three days, they will be sent another email reminder. If they do not complete the surveys within a 
week after the first reminder, they will be called by the study coordinator.
The project coordinator will track participants in REDCap once enrolled and will facilitate 
timely completion of research assessments. All participants will be encouraged to complete 
assessments, regardless of their level of engagement with the FMF Connect Teacher Companion 
website. Actual user data from the website (whether minimal or extensive) will be important in 
addressing study aims. 
Study Assessment Battery
Measure
Number 
Items
Baseline
T2
T3
Screening and Demographics Measure: 
This includes both the screening 
questions and demographics including 
information about teaching experience 
and setting
39
X
FASD Knowledge survey: This was 
adapted from FMF Connect trials and 
assesses knowledge about FASD
28
X
X
X
Perceived Self-Efficacy: The Teacher 
Self Efficacy Scale (TSES) measures 
teachers’ sense of self-efficacy in 
teaching and supporting students in the 
classroom
10
X
X
X
Behavioral Attributions: Attributions 
are measured by the Reasons for 
Children’s Behavior (RCB) across 
seven subscales of behavior and willful 
or ability-based attributions.
30
X
X
Behavioral Strategies: The Behavioral 
Strategies measure was co-normed 
with the RCB and assesses opinions 
about common behavioral strategies in 
the classroom
36
X
X
X
Time spent on student: These 
questions assess how much time on 
average the teacher spends planning 
for their student with FASD.
3
X
X
X
Study Design Feasibility and 
Acceptability: The Study Experiences 
Survey (SES) was developed for this 
study and assesses participants’ 
experiences with the study procedures
10
X
Program Satisfaction: The Mobile 
32
Group 1
X

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Application Rating Scale – User 
Version (uMARS) assesses 
functionality, usefulness, and 
helpfulness of technology and 
information. It is originally used for 
apps but has been adapted for a 
website.
Qualitative Interview on User 
Experience: This is a 30-45 semi-
structured interview assessment 
participants’ experiences of using the 
website and participating in the study 
(see uploaded questioning route)
N/A
Group 1
Group 2
Total number of items at each 
timepoint
116
149 (Group 1)
117 (Group 2)
139
 
Qualitative Interview. The semi-structured questioning route will cover the following topics: 
1) overall impressions of the FMF Connect Teacher Companion website; 2) experience using 
the website (both facilitators and barrier of use); and 3) perceived impact on their teaching 
and classroom experience. Interviews are expected to last about 30-45 minutes. 
FMF Connect Teacher Companion website. The FMF Connect Teacher Companion website 
is designed to offer teachers evidence-based education about FASD and strategies to support 
students with FASD. It is adapted from the FMF Program and FMF Connect, evidence based 
interventions to support caregivers of children with FASD. The FMF Program and FMF 
Connect aim to improve caregivers’ efficacy and satisfaction as a parent, efficacy, 
attributions for their child’s behavior, and the parent-child relationship. This study will test if 
the FMF Connect Teacher Companion website if feasible and acceptable, and measure its 
preliminary effect on these outcomes in teachers.
Usage data from the website will be collected using Azure Application Insights. Application 
Insights allows to identify website utilization patterns like, for example, number of active 
users, number of sessions per user, or specific features that the participants use the most.
10. AUDIO/VIDEO RECORDINGS 
Qualitative interviews will be recorded using HIPAA-complaint Zoom. Research staff will be 
at Mt. Hope Family Center when completing interviews, using UR computers. Recordings 
will be uploaded from the local machine as soon as possible to a URMC Box folder for this 
project managed by the IT team at Mt. Hope Family Center. Only research staff involved on 
this project will have access to recordings. Recordings will then be transcribed verbatim by 
research staff. After all transcripts have been rechecked, audio and video recordings will be 
deleted. 
11. RISKS TO SUBJECTS
Participants may experience psychological risks associated with participation in this study, 
such as discomfort or boredom in answering questions or providing feedback about the 
website. There is also a risk of loss of confidentiality. All data collected for the proposed 

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research study will be kept confidential to the extent allowed by law. Although it is unlikely 
given the nature of this study, if participants disclose that someone is being maltreated or is a 
danger to self or others, research staff will need to break confidentiality to make a report to 
the appropriate authority to ensure safety, as mandated by law. We believe that all identified 
risks are reasonable given the proposed procedures for protecting against risk.  
Protections Against Risks
To minimize risk associated with psychological discomfort, participants will be given the 
option to skip questions they feel uncomfortable answering. Multiple procedures will be 
implemented to protect participant confidentiality. In terms of data storage and management, 
any hard copy data will be secured in locked file cabinets within locked offices, available 
only to program staff. Electronic data will be stored on URMC managed Box folder for this 
project, and only project staff with appropriate permissions will be able to access the data. 
Forms with 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 website. 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 with the website, as well as 
connections between the website and the database, will use state of the art authentication and 
encryption algorithms (e.g., HTTS, SSL and TLS). The Cloud architecture and services will 
be built and are managed by Dr. Tapparello, under a University-managed Azure account, 
and in compliance with University policy. Security and Benchmark compliance reports will 
be received and reviewed by Dr. Tapparello. Access to the data stored on the Cloud will be 
restricted, access to the data with be logged and backups will be created to allow the users to 
restore them if/when necessary. Appropriate policies will be set up so that users will be able 
to add and modify their own data but will be prevented from viewing and modifying other 
users' data. Unique login credentials will be provided to each participant and will be required 
to access the content of FMF Connect Teachers companion website. No personal data will 
be stored by the website on the participant’s device. 
All information obtained for research will be kept strictly confidential (as allowed by law) 
by research staff. Participants will be told about all exceptions (e.g., child/dependent adult 
abuse, harm to self or others) to confidentiality during the consent process. Project staff will 
be closely supervised by Dr. Petrenko and instructed on confidentiality, including what 
information is confidential, the limits of confidentiality, and to whom to report concerns. 
The FMF Connect Teacher Companion website is viewed as a “value-added” intervention. 
Participants can continue to seek information on FASD elsewhere or use their preferred 
behavior management strategies. The alternative to participating in this study is not to 
participate.
12. POTENTIAL BENEFITS TO SUBJECTS
Participants may not experience any direct benefits from participating in this study. 
However, participants in prior FASD research studies at MHFC have commented on how 
they value and derive personal satisfaction in participating in research to increase knowledge 

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about this under-recognized condition and effective strategies to benefit other people with 
FASD. It is also possible, although not guaranteed, that subjects might derive benefit from 
using the FMF Connect Teacher Companion website. Possible benefits may include 
improved self-efficacy, increased knowledge about FASD, and improved classroom 
management and teaching.
13. COSTS FOR PARTICIPATION
There are no costs to participate.
14. PAYMENT FOR PARTICIPATION 
Subjects will receive $25 upon completion of assessments at each timepoint. Those who are 
selected for and complete an interview will receive an additional $25. Payments will be gift 
cards. If a participant withdraws from the study they will receive payment for the timepoints 
they did complete but not for any future timepoints. 
15. SUBJECT WITHDRAWALS
Subjects will be advised during the consent process that they have the right to withdraw 
from the study at any time without prejudice. They can choose to use the website 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 website or found it hard to navigate. This information is useful in identifying 
ways to improve the website and facilitate user engagement. 
Subjects will not be withdrawn without their consent unless they meet the criteria outlined in 
the Fraudulent Participant Protocol (see uploaded). Subjects who are withdrawn under this 
protocol will be replaced and will not count toward final enrollment numbers. Subjects can 
choose not to complete any or all of the study assessments. They can also completely 
withdraw from the study with no future contact if they choose. In this case, any data they 
have previously provided may be used in analyses. 
16. PRIVACY AND CONFIDENTIALITY OF SUBJECTS AND RESEARCH DATA
All data will be used solely for research purposes and will be securely locked in designated 
file cabinets, URMC managed Box folder dedicated to project, Project REDCap database, 
and an encrypted, HIPAA-complaint Cloud database (Azure; for data collected via the 
website; 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 website, which are further detailed in the section 
“Protections Against Risks” and Data Security Assessment form. Only senior key personnel 
and project research staff will have access to the data.
The following table summarizes the project data flow. MHFC IT will set up and manage 
permissions for URMC Project Box folder. Only project staff will have access to REDCap 
and Box folders. 
Data Element
How Data 
Collected
Where Data 
is Stored
How Data is Managed
Information Sheet, 
REDCap
REDCap, 
MHFC IT; Project Staff

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Screening Survey, 
Contact Information
Back-ups 
URMC Box
Baseline (T1) 
Surveys, Timepoint 
2 surveys, 
Timepoint 3 surveys
REDCap
REDCap, 
Back-ups 
URMC Box
MHFC IT; Project Staff
Follow-up Interview
Zoom
URMC Box
MHFC IT; Project Staff; Audio/video 
data is transcribed verbatim; 
audio/videos deleted once transcript 
verified
FMF Connect 
Teacher Companion 
website usage data 
and User’s inserted 
data
Website 
and Azure 
services
URMC-
managed 
account on 
Azure
Access is restricted to authorized 
individuals and every access to the data 
will be logged, data is encrypted in 
transit and at rest. Azure account is set 
up in compliance with UR/URMC 
policies and monitored by ISD.
15. DATA / SAMPLE STORAGE FOR FUTURE USE
All data (de-identified and identifying) will be securely stored locally for an indefinite 
period. De-identified and identifying information will be stored separately as detailed above. 
Novel research questions may arise in the future that this important dataset could answer. 
Retaining identifying information would facilitate contacting individuals (subsequent to new 
IRB approval) to see if they would be interested in participating in follow-up research. 
MHFC has well-established data security procedures in place for long-term storage and 
maintenance of data. Only approved project staff will have access to data. 
16. DATA AND SAFETY MONITORING PLAN
Because the research involves the provision of a website-based intervention for teachers, the 
risk for a serious adverse event due to provision of the intervention is low. Adverse events 
that could occur include adverse events in the classroom involving students with FASD such 
as aggression or violence towards others, maltreatment, self-harm or suicidality, or threats of 
violence to others or to the school. However, these occurrences are unlikely to be a direct 
consequence of participation in the proposed research or intervention. 
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 on 
interventions for caregivers of children with FASD. 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. Additionally, because MHFC provides other treatment 
programs, there are other back-up clinical supervisors available for consultation for 

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immediate needs. A phone tree will be established, similar to other projects at MHFC, and 
will be provided to research staff. Dr. Petrenko will meet with research staff at least weekly 
to provide supervision and will assess participant well-being. Dr. Petrenko will consult with 
other co-Investigators and clinical staff at MHFC, as appropriate, to address participant well-
being concerns. 
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 NICHD. Ethically, we are committed to ensuring the welfare of participants. Any 
significant mental health or safety issues detected during the conduct of this investigation 
will be discussed with participants and options for the receipt of services presented. 
17. DATA ANALYSIS PLAN
Qualitative Interview Data: Data will be analyzed thematically to understand users’ 
experiences with the FMF Connect Teacher Companion website and research trial. Thematic 
analysis focuses on identifying patterns or themes within the data. Consistent with the 
approach advocated by Miles, Huberman, and Saldana (2014), research team members will 
first familiarize themselves with the data, iteratively reviewing each transcript, and 
independently assigning initial codes (“first-level coding”). The team will then come together 
and discuss, operationalize, and refine each code. We will then generate “second-level 
codes” which consider categories or deeper meanings among first-level codes. During this 
process we will examine interrelationships and networks among codes and build a 
preliminary thematic framework. Transcripts will then be recoded and codes refined through 
further discussion and consensus, as needed. Participant and group “fit” with the framework 
will also be assessed, with confirmatory and disconfirmatory evidence for the model 
examined. Participant matrices may also be utilized to examine variance in themes across 
participants and key demographic factors, pre-post intervention change, or usage patterns.
interviews will be coded using qualitative content analysis. 
Quantitative Data Analyses: Quantitative analyses will be largely descriptive, as appropriate 
for pilot trials (Lancaster et al., 2004) and will include effect sizes and 95% confidence 
intervals of the following measures in the assessment battery:

FASD Knowledge survey

Attributions and Behavioral Strategies

Perceived Self-Efficacy (TSES)

Study Design Feasibility and Acceptability (SES)

Program Satisfaction (uMARS)
The below table summarizes how each analysis will address each sub-aim of the current 
study.
Aim
Evaluated Using
Intervention Feasibility
• technological functionality
uMARS means/standard deviations; website 
crash reports; user experience interviews

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• acceptability of website
uMARS means/standard deviations; user 
experience interviews
• typical usage patterns
Website usage data, including frequency, 
length, and timing of use
Study Design Acceptability
• enrollment and attrition rates
N consented; N with complete data; rate of 
attrition
• acceptability of randomization and control 
condition
SES means/standard deviations; user 
experience interviews
• assessment acceptability and sensitivity
Rate of assessment completion; pre-post 
effect sizes and 95% confidence intervals
• optimal intervention length
Website usage patterns
• predictors of attrition
Rate of attrition; demographic and baseline 
variables
18. REFERENCES
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(FASDs): overview of findings for five innovative research projects. Research in 
developmental disabilities, 30(5), 986-1006.
Bowen, D. J., Kreuter, M., Spring, B., Cofta-Woerpel, L., Linnan, L., Weiner, D., ... & 
Fernandez, M. (2009). How we design feasibility studies. American journal of preventive 
medicine, 36(5), 452-457.
Crocker, N., Riley, E. P., & Mattson, S. N. (2015). Visual-spatial abilities relate to mathematics 
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