Status:
ENROLLING_BY_INVITATION
Families Moving Forward Bridges: An Early Intervention for Infants and Toddlers With PAE With or At-risk for FASD
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Prenatal Alcohol Exposure
Fetal Alcohol Spectrum Disorders
Eligibility:
All Genders
6+ years
Phase:
NA
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 C...
Detailed Description
This is an initial feasibility study to examine Families Moving Forward Bridges (FMF Bridges), an FASD-informed early intervention designed to meet the specific needs of young children 6-36 months wit...
Eligibility Criteria
Inclusion
- Child inclusion criteria: Infants and toddlers 6-36 months of age, any gender, any race/ethnicity, who:
- 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.
- Caregiver inclusion criteria:
- biological, foster, adoptive, or other legal guardian;
- age 18 or older;
- any gender.
Exclusion
- Child exclusion criteria:
- 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).
Key Trial Info
Start Date :
April 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06935461
Start Date
April 18 2025
End Date
August 31 2026
Last Update
July 29 2025
Active Locations (1)
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1
Wonderland Child Development Center
Shoreline, Washington, United States, 98177