N/A
N=105
Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention
Fetal Alcohol Spectrum Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04194489 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up — 69.31; 65.62 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FMF Connect (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up |
69.31; 65.62 | — |
| PRIMARY Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up |
32.90; 34.02 | — |
| PRIMARY Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month Follow-up |
22.04; 20.56 | — |
| PRIMARY Family Needs Questionnaire Baseline to 3-Month Follow-up |
2.34; 2.35 | — |
| SECONDARY Participant Perception of Self-care Change Over Intervention Period Reported at 3-month Follow-up |
2.92 | — |
| SECONDARY Mean App Quality Score on Mobile App Rating Scale: User Version |
4.08 | — |
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 with iOS or Android 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
Data sourced from ClinicalTrials.gov (NCT04194489). 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.