By InvitationNot Applicable

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

United States24 participantsStarted 2025-04-18

Plain-language 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.

Who can participate

Age range6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

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).

What they're measuring

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

Timeframe: From enrollment to the end of intervention 3-5 months

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

Timeframe: From enrollment to the end of intervention 3-5 months

Family Outcomes Survey - Revised (FOS-R)

Timeframe: From enrollment to the end of intervention 3-5 months

Healthy Families Parenting Inventory (HFPI)

Timeframe: From enrollment to the end of intervention 3-5 months

Trial details

NCT IDNCT06935461

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

View on ClinicalTrials.gov More Prenatal Alcohol Exposure trials

Who can participate

Age range6 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

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).

What they're measuring

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

Timeframe: From enrollment to the end of intervention 3-5 months

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

Timeframe: From enrollment to the end of intervention 3-5 months

Family Outcomes Survey - Revised (FOS-R)

Timeframe: From enrollment to the end of intervention 3-5 months

Healthy Families Parenting Inventory (HFPI)

Timeframe: From enrollment to the end of intervention 3-5 months