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

NCT06935461 | Enrolling By Invitation DMC

• 2 other identifiers: STUDY000205991R61AA031695-01
• Study Type: interventional
• Estimated enrollment: 24
• Locations: 1 country
• Sites: 1
• Actual (reported): Study Start
• Estimated — date passed: Primary Completion
• Estimated — date passed: Study Completion

Brief Summary

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.

Conditions

Prenatal Alcohol Exposure; Fetal Alcohol Spectrum Disorders

Keywords

early childhood intervention; prenatal alcohol exposure; fetal alcohol spectrum disorder; infants and toddlers; FASD informed intervention

Outcome Measures

Primary Outcomes (4)

• Devereux Early Childhood Assessment-Infant/Toddler (DECA-IT)

  Standardized parent rating scale assessing child initiative, attachment, and self-regulation. Internal consistency (α=.90-.94); test-retest reliability (r= .91-.99).

  From enrollment to the end of intervention 3-5 months

• Parenting Interactions with Children - Checklist of Observations Linked to Outcomes (PICCOLO) 86

  An observational measure of caregiver behavior including affection, responsiveness, encouragement, and teaching through caregiver-child interactions. Internal consistency (α=.75-.80); interrater reliability (r= .74-.80); construct validity (r= .62).

  From enrollment to the end of intervention 3-5 months

• Family Outcomes Survey - Revised (FOS-R)

  Designed to measure family outcomes and helpfulness of early intervention. Parent survey to rate the extent to which they have achieved family outcomes including knowing their rights and advocate effectively for their child, understand their child's strengths and needs, help their child develop and learn, have support systems, and access desired community services, programs, and activities.

  From enrollment to the end of intervention 3-5 months

• Healthy Families Parenting Inventory (HFPI)

  Designed to measure outcomes in home visitation programs. A survey of multiple dimensions of parenting: parent social support, problem solving, depression, personal care, mobilizing resources, role satisfaction, parent-child interactions, the home environment and parenting efficacy. Good internal consistency; evidence for convergent validity.

  From enrollment to the end of intervention 3-5 months

Study Arms (1)

FMF Bridges Early Intervention Program

OTHER

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

Behavioral: Families Moving Forward Bridges

Interventions

Families Moving Forward Bridges BEHAVIORAL

Ten, 60-minute manualized FMF Bridges intervention sessions over 3-5 months (approximately every other week)

FMF Bridges Early Intervention Program

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• have confirmed PAE as ascertained by the standard child development center intake procedures;
• and 2) qualify for IDEA Part C EI services based on presence of a developmental delay (\>25% in one or more areas of development) or therapist/provider informed clinical opinion.
• biological, foster, adoptive, or other legal guardian;
• age 18 or older;
• any gender.

You may not qualify if:

• child has lived with current caregiver for less than 30% of chronological age or there is a planned change in caregiver placement or move out of King County within 3 months of intake;
• child has a medical or congenital/genetic condition that would severely limit participation in assessments, such as a significant visual or hearing impairment, degenerative muscle condition, or uncontrolled seizures;
• multiple birth;
• child currently receives inpatient medical care (e.g., NICU) or has a medical condition requiring a planned inpatient hospitalization or surgical intervention (e.g., heart condition);
• child diagnosis of a known genetic or non-FASD neurodevelopmental condition (e.g., Down syndrome, autism spectrum disorder).

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Wonderland Child Development Center

Shoreline, Washington, 98177, United States

Location

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Tracy Jirikowic, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Rehabilitation Medicine

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 20, 2025
• Last Updated: July 29, 2025

Study Start

April 18, 2025

Actual (reported)

Primary Completion

March 1, 2026

Estimated — date passed

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

August 31, 2026

Estimated — date passed

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Data will become available after analysis is complete. Following the conditions and timeline in the NIMH data archive.
• Access Criteria: Individual level data deidentified will be shared in the NIMH Data Archive.

Locations

US (1)