Efficacy Trial of the FMF Connect Mobile Health Intervention

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University of Rochester

Status

Completed

Conditions

Fetal Alcohol Spectrum Disorders

Treatments

Other: FMF Connect
Other: Coaching

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05028517
STUDY00006555
U01AA026104 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

129 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

129 participants in 3 patient groups

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

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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