Efficacy Trial of the FMF Connect Mobile Health Intervention

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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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.