18 and older, any sex, with Fetal Alcohol Spectrum Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-UpPrimary· 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.
Baseline
Group
Value
95% CI
FMF Connect Intervention + Coaching
68.33
± 1.65
FMF Connect Intervention (no Coaching)
69.13
± 1.88
Waitlist Comparison Group
68.40
± 1.65
12-week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
64.47
± 1.67
FMF Connect Intervention (no Coaching)
65.87
± 1.90
Waitlist Comparison Group
66.03
± 1.67
Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-WeeksPrimary· 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.
Baseline
Group
Value
95% CI
FMF Connect Intervention + Coaching
15.54
± 1.02
FMF Connect Intervention (no Coaching)
18.91
± 1.17
Waitlist Comparison Group
16.57
± 1.01
6-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
15.87
± 1.25
FMF Connect Intervention (no Coaching)
19.29
± 1.45
Waitlist Comparison Group
18.25
± 1.25
12-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
15.43
± 1.29
FMF Connect Intervention (no Coaching)
17.29
± 1.49
Waitlist Comparison Group
17.57
± 1.29
Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-WeeksPrimary· 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.
Baseline
Group
Value
95% CI
FMF Connect Intervention + Coaching
23.79
± 1.06
FMF Connect Intervention (no Coaching)
23.24
± 1.23
Waitlist Comparison Group
23.29
± 1.06
6-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
23.36
± 1.02
FMF Connect Intervention (no Coaching)
25.43
± 1.17
Waitlist Comparison Group
24.39
± 1.02
12-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
22.61
± 1.19
FMF Connect Intervention (no Coaching)
24.76
± 1.37
Waitlist Comparison Group
23.14
± 1.19
Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-WeeksPrimary· 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.
Baseline
Group
Value
95% CI
FMF Connect Intervention + Coaching
10.14
± 0.576
FMF Connect Intervention (no Coaching)
10.67
± 0.665
Waitlist Comparison Group
10.43
± 0.576
6-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
9.18
± 0.527
FMF Connect Intervention (no Coaching)
9.86
± 0.608
Waitlist Comparison Group
10.89
± 0.527
12-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
8.93
± 0.576
FMF Connect Intervention (no Coaching)
8.57
± 0.665
Waitlist Comparison Group
10.46
± 0.576
Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-WeeksPrimary· 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.
Baseline
Group
Value
95% CI
FMF Connect Intervention + Coaching
23.29
± 0.847
FMF Connect Intervention (no Coaching)
22.48
± 0.978
Waitlist Comparison Group
24.32
± 0.847
6-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
22.75
± 0.746
FMF Connect Intervention (no Coaching)
22.77
± 0.862
Waitlist Comparison Group
24.57
± 0.746
12-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
23.00
± 0.922
FMF Connect Intervention (no Coaching)
21.57
± 1.07
Waitlist Comparison Group
23.68
± 0.922
Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-WeeksPrimary· 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.
Baseline
Group
Value
95% CI
FMF Connect Intervention + Coaching
14.96
± 1.28
FMF Connect Intervention (no Coaching)
17.05
± 1.47
Waitlist Comparison Group
15.29
± 1.28
6-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
12.36
± 1.17
FMF Connect Intervention (no Coaching)
13.81
± 1.35
Waitlist Comparison Group
15.50
± 1.17
12 Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
12.07
± 1.25
FMF Connect Intervention (no Coaching)
13.24
± 1.45
Waitlist Comparison Group
14.75
± 1.25
Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-WeeksPrimary· 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.
Baseline
Group
Value
95% CI
FMF Connect Intervention + Coaching
19.50
± 0.744
FMF Connect Intervention (no Coaching)
20.29
± 0.859
Waitlist Comparison Group
20.79
± 0.744
6-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
20.00
± 0.603
FMF Connect Intervention (no Coaching)
21.43
± 0.697
Waitlist Comparison Group
21.43
± 0.603
12-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
19.89
± 0.636
FMF Connect Intervention (no Coaching)
20.91
± 0.735
Waitlist Comparison Group
21.32
± 0.636
Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-WeeksPrimary· 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.
Baseline
Group
Value
95% CI
FMF Connect Intervention + Coaching
8.36
± .709
FMF Connect Intervention (no Coaching)
9.48
± .819
Waitlist Comparison Group
8.964
± .709
6-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
9.43
± .681
FMF Connect Intervention (no Coaching)
10.76
± .786
Waitlist Comparison Group
10.18
± .681
12-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
8.00
± .717
FMF Connect Intervention (no Coaching)
9.38
± .828
Waitlist Comparison Group
9.464
± .717
Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-upPrimary· 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.
Baseline
Group
Value
95% CI
FMF Connect Intervention + Coaching
26.86
± 1.16
FMF Connect Intervention (no Coaching)
26.25
± 1.37
Waitlist Comparison Group
25.32
± 1.16
6-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
27.36
± 1.15
FMF Connect Intervention (no Coaching)
27.15
± 1.37
Waitlist Comparison Group
25.50
± 1.15
12-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
28.39
± 1.14
FMF Connect Intervention (no Coaching)
29.30
± 1.35
Waitlist Comparison Group
26.71
± 1.14
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-upPrimary· 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.
Baseline
Group
Value
95% CI
FMF Connect Intervention + Coaching
35.36
± 1.43
FMF Connect Intervention (no Coaching)
32.25
± 1.70
Waitlist Comparison Group
33.14
± 1.43
6-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
36.43
± 1.27
FMF Connect Intervention (no Coaching)
35.20
± 1.50
Waitlist Comparison Group
32.68
± 1.27
12-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
35.89
± 1.39
FMF Connect Intervention (no Coaching)
36.15
± 1.65
Waitlist Comparison Group
32.82
± 1.39
Family Needs Questionnaire Baseline to 12-Week Follow-upPrimary· 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.
Baseline
Group
Value
95% CI
FMF Connect Intervention + Coaching
40.63
± 1.79
FMF Connect Intervention (no Coaching)
37.18
± 2.09
Waitlist Comparison Group
37.93
± 1.82
12-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
48.47
± 2.07
FMF Connect Intervention (no Coaching)
47.00
± 2.42
Waitlist Comparison Group
42.38
± 2.11
FASD Knowledge at Baseline and 12-Week Follow-upPrimary· 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.
Baseline
Group
Value
95% CI
FMF Connect Intervention + Coaching
20.97
± .521
FMF Connect Intervention (no Coaching)
21.41
± .609
Waitlist Comparison Group
20.73
± .521
12-Week Follow-up
Group
Value
95% CI
FMF Connect Intervention + Coaching
21.30
± .566
FMF Connect Intervention (no Coaching)
22.36
± .661
Waitlist Comparison Group
20.30
± .566
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT04194489 — Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention
· NA
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Rochester
Last refreshed: 14 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05028517.