Fetal Alcohol Spectrum DisordersNCT05028517

Efficacy Trial of the FMF Connect Mobile Health Intervention

A study testing FMF Connect and Coaching in people with Fetal Alcohol Spectrum Disorders, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Fetal Alcohol Spectrum Disorders
What is being tested?: FMF Connect and Coaching
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: 1 siteUnited States
Study dates: 6 Jan 2022to 31 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Biological parent or other primary caregiver (e.g., foster or adoptive parent, relative, legal guardian) of a child with FASD or prenatal alcohol exposure (PAE)
The parent/caregiver must be at least 18 years old
The child must between the ages of 3 and 12 years old
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

Who cannot join

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 family has previously received or is currently receiving the therapist-led Families Moving Forward (FMF) Program - The caregiver participated in a prior trial of the FMF Connect app as part of earlier development phases

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester Medical Center
Rochester, New York, 14642

Other trials in United States

About this study

The purpose of this study is to test a new smartphone "app" for parents/caregivers of children with fetal alcohol spectrum disorder (FASD). The app is called Families Moving Forward (FMF) Connect. The goal of the app is to provide parents/caregivers with useful information to help manage their children's condition and obtain peer support.

Conditions: Fetal Alcohol Spectrum Disorders
Being tested: FMF Connect, Coaching
Medical subject headings: Fetal Alcohol Spectrum Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FMF ConnectOther
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.
CoachingOther
A text-based coaching module is added to the FMF Connect app. Coaches support continued use of the app and individualized goal setting.

Study groups in NCT05028517
Study group	Role	What they receive
FMF Connect Intervention + Coaching	Experimental	Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting. Receives: Other: FMF Connect; Other: Coaching
FMF Connect Intervention (no coaching)	Experimental	Participants receive the FMF Connect mobile health app. They do not receive coaching. Receives: Other: FMF Connect
Waitlist comparison group	No intervention	Participants receive the FMF Connect mobile health app at the conclusion of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up
The Eyberg Child Behavior Inventory measures the intensity of child behavior problems. Scores are presented as T-scores with a mean of 50 and a standard deviation of 10. A T-score of 60 or higher is considered clinically significant. Higher scores indicate more intense behavior problems.
Measured: baseline to 12 weeks
Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Sensory Avoid scale measures attributions of behavior based on sensory avoidance. It ranges from 5 to 30 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Measured: baseline, 6 weeks, 12 weeks
Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Sensory Seek scale measures attributions of behavior based on sensory seeking. It ranges from 5 to 30 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Measured: baseline, 6 weeks, 12 weeks
Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Task Willful scale measures attributions of behavior based on willful task avoidance. It ranges from 3 to 18 with higher scores reflecting greater agreement with willful attributions.
Measured: baseline, 6 weeks, 12 weeks
Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Task Ability scale measures attributions of behavior based on ability to complete tasks. It ranges from 5 to 30 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Measured: baseline, 6 weeks, 12 weeks
Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Disruptive Behavior scale measures attributions of behavior based on purposeful disruptive behavior. It ranges from 5 to 30 with higher scores reflecting greater agreement with willful attributions.
Measured: baseline, 6 weeks, 12 weeks
Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Emotional Support scale measures attributions of behavior based on need for emotional support. It ranges from 4 to 24 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Measured: baseline, 6 weeks, 12 weeks
Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Dysregulated Behavior scale measures attributions of behavior based on dysregulated behavior. It ranges from 3 to 18 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Measured: baseline, 6 weeks, 12 weeks
Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up
The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The efficacy sub-scale reported here measures how effective parents feel they are and includes 7 items, rated on a scale from 1 ("strongly agree") to 6 ("strongly disagree"). Responses are summed, with possible sub-scale score range from 7 to 42 with higher scores indicating lower feelings of efficacy.
Measured: baseline, 6 weeks, 12 weeks
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up
The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The satisfaction sub-scale reported here includes 9 items, rated on a scale from 1 ("strongly agree") to 6 ("strongly disagree"). Responses are summed, with possible sub-scale score range from 9 to 54 with higher scores indicating higher satisfaction in the parenting role.
Measured: baseline, 6 weeks, 12 weeks
Family Needs Questionnaire Baseline to 12-Week Follow-up
The family needs questionnaire measures the degree to which family needs are met. The scale includes 18 items reflecting family needs that are rated on a scale from 0 to 4, with 0 being not applicable to 4 being met a great deal. The total score on this measure is created by summing across all items. Total score ranges from 0-72. Higher scores reflect more needs being met.
Measured: baseline to 12 weeks
FASD Knowledge at Baseline and 12-Week Follow-up
The Knowledge and Advocacy questionnaire assesses caregiver knowledge about FASD and advocacy and ranges from 0 to 28. Higher scores reflect greater knowledge.
Measured: baseline to 12 weeks

Secondary outcomes (2)

Participant Perception of Self-care Change Over Intervention Period Reported at 12-week Follow-up
Participants are asked at follow-up to rate how much their self-care practices have changed over the last 3 months on a 5-point scale ranging from "A lot less self-care (1)" to "A lot more self-care (5)." A score of 3 equates to no change.
Measured: 12 weeks
Mean App Quality Score on Mobile App Rating Scale: User Version
The mobile app rating scale includes a measure of users perception of app quality. There are 16 items contributing to this score, each rated on a scale from 1 to 5. Total app quality score is presented as a mean with range of 1 to 5, with higher scores reflecting greater perceived quality of the app.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 202231 Dec 2022

First posted31 Aug 2021
Study start6 Jan 2022
Primary completion31 Dec 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
More trials run by University of RochesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study involves a three arm randomized controlled trial 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).
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05028517
Sponsor's protocol ID: STUDY00006555
Other IDs: U01AA026104
Status last verified: Dec 2025
First submitted: 24 Aug 2021
Last updated: 14 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data is deposited quarterly into the Collaborative Initiative on Fetal Alcohol Spectrum Disorders central repository.

Publications

Petrenko CLM, Rockhold MN, Myers JM, Tapparello C, Kautz-Turnbull C, Speybroeck E, Li Z, Cole LL, Olson HC. Families Moving Forward Connect mHealth Intervention for Caregivers of Children With Fetal Alcohol Spectrum Disorders: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Mar 20;14:e73647. doi: 10.2196/73647.
PubMed 41861374

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
Fetal Alcohol Spectrum Disorders, Attention Deficit Hyperactivity Disorder
Not yet recruitingPhase 2
FASD Prevention R33
Alcohol and Tobacco/Cannabis Use
Recruiting
Families Moving Forward (FMF) Connect Pro for Mental Health Providers
Fetal Alcohol Spectrum Disorders
Recruiting
The Synchrony Study: Examining Music Training for Children With FASD
Fetal Alcohol Spectrum Disorders

All Fetal Alcohol Spectrum Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy Trial of the FMF Connect Mobile Health Intervention
ClinicalTrials.gov ID: NCT05028517
Acronym / sponsor ID: STUDY00006555
Conditions: Fetal Alcohol Spectrum Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 6 Jan 2022 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 31 Aug 2021 (actual)
Results: Posted 22 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: This study involves a three arm randomized controlled trial 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).

Arm	Type	Receives
FMF Connect Intervention + Coaching	Experimental	Other: FMF Connect, Other: CoachingParticipants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
FMF Connect Intervention (no coaching)	Experimental	Other: FMF ConnectParticipants receive the FMF Connect mobile health app. They do not receive coaching.
Waitlist comparison group	No intervention	–Participants receive the FMF Connect mobile health app at the conclusion of the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Biological parent or other primary caregiver (e.g., foster or adoptive parent, relative, legal guardian) of a child with FASD or prenatal alcohol exposure (PAE)
The parent/caregiver must be at least 18 years old
The child must between the ages of 3 and 12 years old
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

Key exclusion criteria (3 listed)

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 family has previously received or is currently receiving the therapist-led Families Moving Forward (FMF) Program - The caregiver participated in a prior trial of the FMF Connect app as part of earlier development phases

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FMF ConnectThe 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.	Other	FMF Connect Intervention (no coaching), FMF Connect Intervention + Coaching
CoachingA text-based coaching module is added to the FMF Connect app. Coaches support continued use of the app and individualized goal setting.	Other	FMF Connect Intervention + Coaching

Primary outcome

Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up
Time frame: baseline to 12 weeks
The Eyberg Child Behavior Inventory measures the intensity of child behavior problems. Scores are presented as T-scores with a mean of 50 and a standard deviation of 10. A T-score of 60 or higher is considered clinically significant. Higher scores indicate more intense behavior problems.
Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks
Time frame: baseline, 6 weeks, 12 weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Sensory Avoid scale measures attributions of behavior based on sensory avoidance. It ranges from 5 to 30 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks
Time frame: baseline, 6 weeks, 12 weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Sensory Seek scale measures attributions of behavior based on sensory seeking. It ranges from 5 to 30 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks
Time frame: baseline, 6 weeks, 12 weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Task Willful scale measures attributions of behavior based on willful task avoidance. It ranges from 3 to 18 with higher scores reflecting greater agreement with willful attributions.
Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks
Time frame: baseline, 6 weeks, 12 weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Task Ability scale measures attributions of behavior based on ability to complete tasks. It ranges from 5 to 30 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
Time frame: baseline, 6 weeks, 12 weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Disruptive Behavior scale measures attributions of behavior based on purposeful disruptive behavior. It ranges from 5 to 30 with higher scores reflecting greater agreement with willful attributions.
Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks
Time frame: baseline, 6 weeks, 12 weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Emotional Support scale measures attributions of behavior based on need for emotional support. It ranges from 4 to 24 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
Time frame: baseline, 6 weeks, 12 weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Dysregulated Behavior scale measures attributions of behavior based on dysregulated behavior. It ranges from 3 to 18 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up
Time frame: baseline, 6 weeks, 12 weeks
The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The efficacy sub-scale reported here measures how effective parents feel they are and includes 7 items, rated on a scale from 1 ("strongly agree") to 6 ("strongly disagree"). Responses are summed, with possible sub-scale score range from 7 to 42 with higher scores indicating lower feelings of efficacy.
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up
Time frame: baseline, 6 weeks, 12 weeks
The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The satisfaction sub-scale reported here includes 9 items, rated on a scale from 1 ("strongly agree") to 6 ("strongly disagree"). Responses are summed, with possible sub-scale score range from 9 to 54 with higher scores indicating higher satisfaction in the parenting role.
Family Needs Questionnaire Baseline to 12-Week Follow-up
Time frame: baseline to 12 weeks
The family needs questionnaire measures the degree to which family needs are met. The scale includes 18 items reflecting family needs that are rated on a scale from 0 to 4, with 0 being not applicable to 4 being met a great deal. The total score on this measure is created by summing across all items. Total score ranges from 0-72. Higher scores reflect more needs being met.
FASD Knowledge at Baseline and 12-Week Follow-up
Time frame: baseline to 12 weeks
The Knowledge and Advocacy questionnaire assesses caregiver knowledge about FASD and advocacy and ranges from 0 to 28. Higher scores reflect greater knowledge.

2 secondary outcomes

Participant Perception of Self-care Change Over Intervention Period Reported at 12-week Follow-up
Time frame: 12 weeks
Mean App Quality Score on Mobile App Rating Scale: User Version
Time frame: 12 weeks

Results and safety

Results posted to the registry on 22 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FMF Connect Intervention + Coaching	43	30
FMF Connect Intervention (no Coaching)	43	23
Waitlist Comparison Group	43	30

Primary outcome: Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up

Time frame: baseline to 12 weeks. Mean (Standard Error). Unit: T-score

Measure	FMF Connect Intervention + Coaching n = 30	FMF Connect Intervention (no Coaching) n = 23	Waitlist Comparison Group n = 30
Baseline	68.33 (1.65)	69.13 (1.88)	68.40 (1.65)
12-week Follow-up	64.47 (1.67)	65.87 (1.90)	66.03 (1.67)

FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group: ANOVA Omnibus F test: 0.511, p = .602, ANOVA
FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group: Cohen's d: -0.22 (95% CI -0.69 to 0.23), p = .33, Regression, Linear

Population analysed: Data was analyzed from participants with complete data on the measure from both timepoints.

Primary outcome: Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks

Time frame: baseline, 6 weeks, 12 weeks. Mean (Standard Error). Unit: score on a scale

Measure	FMF Connect Intervention + Coaching n = 28	FMF Connect Intervention (no Coaching) n = 21	Waitlist Comparison Group n = 28
Baseline	15.54 (1.02)	18.91 (1.17)	16.57 (1.01)
6-Week Follow-up	15.87 (1.25)	19.29 (1.45)	18.25 (1.25)
12-Week Follow-up	15.43 (1.29)	17.29 (1.49)	17.57 (1.29)

FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group: ANOVA Omnibus F test: 1.245, p = .294, ANOVA
FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group: p = .524, Mixed Models Analysis

Population analysed: Data was analyzed from participants with complete data on the measure from all timepoints.

Primary outcome: Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks

Time frame: baseline, 6 weeks, 12 weeks. Mean (Standard Error). Unit: score on a scale

Measure	FMF Connect Intervention + Coaching n = 28	FMF Connect Intervention (no Coaching) n = 21	Waitlist Comparison Group n = 28
Baseline	23.79 (1.06)	23.24 (1.23)	23.29 (1.06)
6-Week Follow-up	23.36 (1.02)	25.43 (1.17)	24.39 (1.02)
12-Week Follow-up	22.61 (1.19)	24.76 (1.37)	23.14 (1.19)

FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group: Anova Omnibus F test: 2.585, p = .039, ANOVA
FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group: p = .548, Mixed Models Analysis

Population analysed: Data was analyzed from participants with complete data on the measure from all timepoints.

Primary outcome: Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks

Time frame: baseline, 6 weeks, 12 weeks. Mean (Standard Error). Unit: score on a scale

Measure	FMF Connect Intervention + Coaching n = 28	FMF Connect Intervention (no Coaching) n = 21	Waitlist Comparison Group n = 28
Baseline	10.14 (0.576)	10.67 (0.665)	10.43 (0.576)
6-Week Follow-up	9.18 (0.527)	9.86 (0.608)	10.89 (0.527)
12-Week Follow-up	8.93 (0.576)	8.57 (0.665)	10.46 (0.576)

FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group: Anova Omnibus F test: 2.723, p = 0.032, ANOVA
FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group: p = .013, Mixed Models Analysis

Population analysed: Data was analyzed from participants with complete data on the measure from all timepoints.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FMF Connect Intervention + Coaching	0 of 43 (0%)	0 of 43 (0%)	0 of 43
FMF Connect Intervention (no Coaching)	0 of 43 (0%)	0 of 43 (0%)	0 of 43
Waitlist Comparison Group	0 of 43 (0%)	0 of 43 (0%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41861374Petrenko CLM, Rockhold MN, Myers JM, Tapparello C, Kautz-Turnbull C, Speybroeck E, Li Z, Cole LL, Olson HC. Families Moving Forward Connect mHealth Intervention for Caregivers of Children With Fetal Alcohol Spectrum Disorders: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Mar 20;14:e73647. doi: 10.2196/73647.
Individual participant dataSharing planned: Yes. Data is deposited quarterly into the Collaborative Initiative on Fetal Alcohol Spectrum Disorders central repository.

Related trials for Fetal Alcohol Spectrum Disorders

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
Fetal Alcohol Spectrum Disorders, Attention Deficit Hyperactivity Disorder
Not yet recruitingPhase 2
FASD Prevention R33
Alcohol and Tobacco/Cannabis Use
Recruiting
Families Moving Forward (FMF) Connect Pro for Mental Health Providers
Fetal Alcohol Spectrum Disorders
Recruiting
The Synchrony Study: Examining Music Training for Children With FASD
Fetal Alcohol Spectrum Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FMF Connect and Coaching in people with Fetal Alcohol Spectrum Disorders, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up (time frame: baseline to 12 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05028517, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.