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CompletedNCT05028517Updated Jan 14, 2026Results posted

Efficacy Trial of the FMF Connect Mobile Health Intervention

An interventional study of FMF Connect and Coaching in Fetal Alcohol Spectrum Disorders, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-14.

Sponsored by University of Rochester · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
129
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Fetal Alcohol Spectrum Disorders
03

In context

Fetal Alcohol Spectrum Disorders

63 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.

This study's enrollment of 129 is above the median of 70 across 55 interventional studies indexed under Fetal Alcohol Spectrum Disorders.

Browse Fetal Alcohol Spectrum Disorders studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

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 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
129 participants (actual)

Study arms

  • Experimental
    FMF Connect Intervention + Coaching

    Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.

    Other: FMF Connect · Other: Coaching

  • Experimental
    FMF Connect Intervention (no coaching)

    Participants receive the FMF Connect mobile health app. They do not receive coaching.

    Other: FMF Connect

  • No intervention
    Waitlist comparison group

    Participants receive the FMF Connect mobile health app at the conclusion of the study.

Interventions

  • OtherFMF Connect

    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.

  • OtherCoaching

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline to 12 weeks

  2. 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.

    Time frame: baseline, 6 weeks, 12 weeks

  3. 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.

    Time frame: baseline, 6 weeks, 12 weeks

  4. 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.

    Time frame: baseline, 6 weeks, 12 weeks

  5. 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.

    Time frame: baseline, 6 weeks, 12 weeks

  6. 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.

    Time frame: baseline, 6 weeks, 12 weeks

  7. 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.

    Time frame: baseline, 6 weeks, 12 weeks

  8. 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.

    Time frame: baseline, 6 weeks, 12 weeks

  9. 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.

    Time frame: baseline, 6 weeks, 12 weeks

  10. 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.

    Time frame: baseline, 6 weeks, 12 weeks

  11. 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.

    Time frame: baseline to 12 weeks

  12. 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.

    Time frame: baseline to 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

07

Results

Posted Dec 22, 2023

Participant flow

Participant flow — Overall Study
MilestoneFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Started434343
Completed baseline surveys413939
Completed 6-week follow-up surveys302832
Completed302330
Not completed132013
Withdrew: Lost to follow-up132012
Withdrew: Withdrawal by subject001

Outcome measures

PrimaryEyberg 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.

Time frame:
baseline to 12 weeks
Reported as:
Mean · T-score
Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up
T-scoreFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Baseline68.33 ± 1.6569.13 ± 1.8868.40 ± 1.65
12-week Follow-up64.47 ± 1.6765.87 ± 1.9066.03 ± 1.67
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · ANOVA · p = .602 · Anova omnibus f test: 0.511
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · Regression, Linear · p = .33 (False discovery rate (FDR) correction for multiple comparisons, p=.334.) · Cohen's d: -0.22 · 95% CI -0.69 to 0.23
PrimaryReasons 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.

Time frame:
baseline, 6 weeks, 12 weeks
Reported as:
Mean · score on a scale
Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks
score on a scaleFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Baseline15.54 ± 1.0218.91 ± 1.1716.57 ± 1.01
6-Week Follow-up15.87 ± 1.2519.29 ± 1.4518.25 ± 1.25
12-Week Follow-up15.43 ± 1.2917.29 ± 1.4917.57 ± 1.29
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · ANOVA · p = .294 · Anova omnibus f test: 1.245
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · Mixed Models Analysis · p = .524 (False discovery rate (FDR) correction for multiple comparisons, p=.602)F(2) = .652
PrimaryReasons 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.

Time frame:
baseline, 6 weeks, 12 weeks
Reported as:
Mean · score on a scale
Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks
score on a scaleFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Baseline23.79 ± 1.0623.24 ± 1.2323.29 ± 1.06
6-Week Follow-up23.36 ± 1.0225.43 ± 1.1724.39 ± 1.02
12-Week Follow-up22.61 ± 1.1924.76 ± 1.3723.14 ± 1.19
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · ANOVA · p = .039 · Anova omnibus f test: 2.585
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · Mixed Models Analysis · p = .548 (False discovery rate (FDR) correction for multiple comparisons, p=.893)F(2) = .606
PrimaryReasons 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.

Time frame:
baseline, 6 weeks, 12 weeks
Reported as:
Mean · score on a scale
Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks
score on a scaleFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Baseline10.14 ± 0.57610.67 ± 0.66510.43 ± 0.576
6-Week Follow-up9.18 ± 0.5279.86 ± 0.60810.89 ± 0.527
12-Week Follow-up8.93 ± 0.5768.57 ± 0.66510.46 ± 0.576
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · ANOVA · p = 0.032 · Anova omnibus f test: 2.723
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · Mixed Models Analysis · p = .013 (False discovery rate (FDR) correction for multiple comparisons, p=.143)F(2) = 4.595
PrimaryReasons 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.

Time frame:
baseline, 6 weeks, 12 weeks
Reported as:
Mean · score on a scale
Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks
score on a scaleFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Baseline23.29 ± 0.84722.48 ± 0.97824.32 ± 0.847
6-Week Follow-up22.75 ± 0.74622.77 ± 0.86224.57 ± 0.746
12-Week Follow-up23.00 ± 0.92221.57 ± 1.0723.68 ± 0.922
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · ANOVA · p = 0.672 · Anova omnibus f test: 0.588
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · Mixed Models Analysis · p = .463 (False discovery rate (FDR) correction for multiple comparisons, p=.893)F(2) = .776
PrimaryReasons 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.

Time frame:
baseline, 6 weeks, 12 weeks
Reported as:
Mean · score on a scale
Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
score on a scaleFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Baseline14.96 ± 1.2817.05 ± 1.4715.29 ± 1.28
6-Week Follow-up12.36 ± 1.1713.81 ± 1.3515.50 ± 1.17
12 Week Follow-up12.07 ± 1.2513.24 ± 1.4514.75 ± 1.25
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · ANOVA · p = 0.038 · Anova omnibus f test: 2.612
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · Mixed Models Analysis · p = .084 (False discovery rate (FDR) correction for multiple comparisons, p=.462)F(2) = 2.544
PrimaryReasons 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.

Time frame:
baseline, 6 weeks, 12 weeks
Reported as:
Mean · score on a scale
Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks
score on a scaleFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Baseline19.50 ± 0.74420.29 ± 0.85920.79 ± 0.744
6-Week Follow-up20.00 ± 0.60321.43 ± 0.69721.43 ± 0.603
12-Week Follow-up19.89 ± 0.63620.91 ± 0.73521.32 ± 0.636
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · ANOVA · p = .940 · Anova omnibus f test: 0.196
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · Mixed Models Analysis · p = .961 (False discovery rate (FDR) correction for multiple comparisons, p=.961)F(2) = .040
PrimaryReasons 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.

Time frame:
baseline, 6 weeks, 12 weeks
Reported as:
Mean · score on a scale
Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
score on a scaleFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Baseline8.36 ± .7099.48 ± .8198.964 ± .709
6-Week Follow-up9.43 ± .68110.76 ± .78610.18 ± .681
12-Week Follow-up8.00 ± .7179.38 ± .8289.464 ± .717
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · ANOVA · p = .671 · Anova omnibus f test: 0.590
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · Mixed Models Analysis · p = .190 (False discovery rate (FDR) correction for multiple comparisons, p=.523)F(2)=1.696
PrimaryParenting 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.

Time frame:
baseline, 6 weeks, 12 weeks
Reported as:
Mean · score on a scale
Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up
score on a scaleFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Baseline26.86 ± 1.1626.25 ± 1.3725.32 ± 1.16
6-Week Follow-up27.36 ± 1.1527.15 ± 1.3725.50 ± 1.15
12-Week Follow-up28.39 ± 1.1429.30 ± 1.3526.71 ± 1.14
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · ANOVA · p = .468 · Anova omnibus f test: .896
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · Mixed Models Analysis · p = .683 (False discovery rate (FDR) correction for multiple comparisons, p=.817)F(2) = .384
PrimaryParenting 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.

Time frame:
baseline, 6 weeks, 12 weeks
Reported as:
Mean · score on a scale
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up
score on a scaleFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Baseline35.36 ± 1.4332.25 ± 1.7033.14 ± 1.43
6-Week Follow-up36.43 ± 1.2735.20 ± 1.5032.68 ± 1.27
12-Week Follow-up35.89 ± 1.3936.15 ± 1.6532.82 ± 1.39
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · ANOVA · p = 0.01 · Anova omnibus f test: 3.42
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · Mixed Models Analysis · p = .131 (False discovery rate (FDR) correction for multiple comparisons, p=.480)F(2)=2.081
PrimaryFamily 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.

Time frame:
baseline to 12 weeks
Reported as:
Mean · score on a scale
Family Needs Questionnaire Baseline to 12-Week Follow-up
score on a scaleFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Baseline40.63 ± 1.7937.18 ± 2.0937.93 ± 1.82
12-Week Follow-up48.47 ± 2.0747.00 ± 2.4242.38 ± 2.11
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · ANOVA · p = .257 · Anova omnibus f test: 1.384
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · Regression, Linear · p = .039 (False discovery rate (FDR) correction for multiple comparisons, p=.055) · Cohen's d: 0.49 · 95% CI -0.02 to 0.94
PrimaryFASD 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.

Time frame:
baseline to 12 weeks
Reported as:
Mean · score on a scale
FASD Knowledge at Baseline and 12-Week Follow-up
score on a scaleFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Baseline20.97 ± .52121.41 ± .60920.73 ± .521
12-Week Follow-up21.30 ± .56622.36 ± .66120.30 ± .566
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · ANOVA · p = .192 · Anova omnibus f test: 1.686
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · Regression, Linear · p = .039 (False discovery rate (FDR) correction for multiple comparisons, p=.055) · Cohen's d: 0.47 · 95% CI 0.02 to 0.93
SecondaryParticipant 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.

Time frame:
12 weeks
Reported as:
Mean · score on a scale
Participant Perception of Self-care Change Over Intervention Period Reported at 12-week Follow-up
score on a scaleFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison Group
Participant Perception of Self-care Change Over Intervention Period Reported at 12-week Follow-up3.10 ± 1.063.18 ± .7952.90 ± .885
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · ANOVA · p = .524 · Anova omnibus f test: .651
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) vs Waitlist Comparison Group · Regression, Linear · p = .048 (False discovery rate (FDR) correction for multiple comparisons, p=.066) · Cohen's d: 0.46 · 95% CI 0.00 to 0.91
SecondaryMean 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.

Time frame:
12 weeks
Reported as:
Mean · score on a scale
Mean App Quality Score on Mobile App Rating Scale: User Version
score on a scaleFMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)
Mean App Quality Score on Mobile App Rating Scale: User Version4.13 ± .394.24 ± .32
Statistical analysis
  • FMF Connect Intervention + Coaching vs FMF Connect Intervention (no Coaching) · ANOVA · p = .255 · Anova omnibus f test: 1.32

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
FMF Connect Intervention + Coaching0/43 (0%)0/43 (0%)0/43 (0%)
FMF Connect Intervention (no Coaching)0/43 (0%)0/43 (0%)0/43 (0%)
Waitlist Comparison Group0/43 (0%)0/43 (0%)0/43 (0%)

Baseline characteristics

A total of 129 participants enrolled in the study and were allocated to the 3 arms. Demographic variables were provided at study enrollment. Data is available for demographics (age, sex, race, ethnicity, region) for 129 participants (43 per study arm). 10 participants did not complete baseline surveys, resulting in 119 participants with data for survey measures (Eyberg Child Behavior Inventory, Reasons for Children's Behavior, Parenting Sense of Competence, Family Needs Met, FASD Knowledge).

Age, Continuous
Age, Continuous(years)FMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison GroupTotal
Mean45.2 ± 7.043.1 ± 7.643.7 ± 7.644.00 ± 7.38
Sex: Female, Male
Sex: Female, Male(Participants)FMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison GroupTotal
Female434140124
Male0235
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)FMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison GroupTotal
Hispanic or Latino1034
Not Hispanic or Latino414340124
Unknown or Not Reported1001
Race (NIH/OMB)
Race (NIH/OMB)(Participants)FMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison GroupTotal
American Indian or Alaska Native0000
Asian00000
Native Hawaiian or Other Pacific Islander0000
Black or African American2024
White404139120
More than one race0213
Unknown or Not Reported1012
Region of Enrollment
Region of Enrollment(participants)FMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison GroupTotal
United States434343129
Eyberg Child Behavior Inventory - Intensity Scale
Eyberg Child Behavior Inventory - Intensity Scale(T-score)FMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison GroupTotal
Mean69.20 ± 8.8669.51 ± 7.1468.28 ± 9.0169.00 ± 8.33
Reasons for Children's Behavior Scale - Sensory Avoid
Reasons for Children's Behavior Scale - Sensory Avoid(units on a scale)FMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison GroupTotal
Mean16.20 ± 5.3219.18 ± 5.9915.64 ± 6.0616.99 ± 5.95
Reasons for Children's Behavior Scale - Sensory Seek
Reasons for Children's Behavior Scale - Sensory Seek(units on a scale)FMF Connect Intervention + CoachingFMF Connect Intervention (no Coaching)Waitlist Comparison GroupTotal
Mean23.15 ± 6.4323.90 ± 4.9822.56 ± 6.6923.20 ± 6.06

9 further baseline measures are reported on the registry.

08

Study locations

1 site
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 13, 2021
  • Informed consent form · Aug 9, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Data is deposited quarterly into the Collaborative Initiative on Fetal Alcohol Spectrum Disorders central repository.

Supporting information: Study protocol, Sap, Icf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05028517
Lead sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Christie Petrenko (Research Associate Professor, University of Rochester) — Principal investigator
First posted
Aug 31, 2021
Start date
Jan 6, 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Results posted
Dec 22, 2023
Last update
Jan 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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