Families Moving Forward Bridges: An Early Intervention for Infants and Toddlers With PAE With or At-risk for FASD

Part of paid clinical trials in Shoreline, Washington.

Sponsor
University of Washington
Study ID
NCT06935461
Status
Enrolling By Invitation

Conditions

  • Fetal Alcohol Spectrum Disorders
  • Prenatal Alcohol Exposure

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Families Moving Forward Bridges — BEHAVIORAL
    Ten, 60-minute manualized FMF Bridges intervention sessions over 3-5 months (approximately every other week)

Study Details

This is an unblinded, feasibility study of an adapted positive parenting intervention to be carried out in a small sample (n=12 dyads) of young children with FASD and their primary caregiver in King County, WA.

Key Dates

Start date
Apr 18, 2025
Status verified
Jul 2025
Primary completion
Mar 1, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: FMF Bridges Early Intervention Program
    Following enrollment, a baseline assessment session will be completed (see caregiver and child assessments document uploaded). Following the assessment, the caregiver will receive intervention services from a trained FMF Bridges Specialists from Wonderland Child and Family Services within 1 month of completing the baseline assessment. The trained EI providers will deliver the FMF Bridges intervention, comprised of 10, 60-minute manualized intervention sessions (see FMF Bridges Intervention Protocol and Materials document). Sessions are expected to be delivered weekly or bi-weekly in the home (the standard of care for EI services), over a 3-to-5-month time period, with those electing to complete weekly sessions taking approximately 3 months or up to 5 for those who choose biweekly sessions. Outcome measures will be immediately post-intervention, as close as possible to the last session, and within 1 month of completing the intervention. Outcome measures at baseline and post interventio

Primary Outcome Measure

Devereux Early Childhood Assessment-Infant/Toddler (DECA-IT) [ Time Frame: From enrollment to the end of intervention 3-5 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wonderland Child Development CenterShorelineWashington98177-

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By research site
Wonderland Child Development Center· Shoreline, WA

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