N/A N=129 Randomized Single-blind Treatment

Efficacy Trial of the FMF Connect Mobile Health Intervention

Fetal Alcohol Spectrum Disorders

Bottom Line

View on ClinicalTrials.gov: NCT05028517 ↗

Enrolled (actual)

129

Serious AEs

0.0%

Results posted

Dec 2023

Primary outcome: Primary: Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up — 68.33; 69.13; 68.40; 64.47 T-score — p=.602

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FMF Connect (Other); Coaching (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Rochester
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up	68.33; 69.13; 68.40; 64.47; 65.87; 66.03	.602
PRIMARY Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks	15.54; 18.91; 16.57; 15.87; 19.29; 18.25	.294
PRIMARY Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks	23.79; 23.24; 23.29; 23.36; 25.43; 24.39	.039 sig
PRIMARY Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks	10.14; 10.67; 10.43; 9.18; 9.86; 10.89	0.032 sig
PRIMARY Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks	23.29; 22.48; 24.32; 22.75; 22.77; 24.57	0.672
PRIMARY Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks	14.96; 17.05; 15.29; 12.36; 13.81; 15.50	0.038 sig
PRIMARY Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks	19.50; 20.29; 20.79; 20.00; 21.43; 21.43	.940
PRIMARY Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks	8.36; 9.48; 8.964; 9.43; 10.76; 10.18	.671
PRIMARY Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up	26.86; 26.25; 25.32; 27.36; 27.15; 25.50	.468
PRIMARY Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up	35.36; 32.25; 33.14; 36.43; 35.20; 32.68	0.01 sig
PRIMARY Family Needs Questionnaire Baseline to 12-Week Follow-up	40.63; 37.18; 37.93; 48.47; 47.00; 42.38	.257
PRIMARY FASD Knowledge at Baseline and 12-Week Follow-up	20.97; 21.41; 20.73; 21.30; 22.36; 20.30	.192
SECONDARY Participant Perception of Self-care Change Over Intervention Period Reported at 12-week Follow-up	3.10; 3.18; 2.90	.524
SECONDARY Mean App Quality Score on Mobile App Rating Scale: User Version	4.13; 4.24	.255

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.

Eligibility Criteria

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05028517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.