Clinical trial NCT06935461: Families Moving Forward Bridges: An Early Intervention for Infants and Toddlers With PAE With or At-risk for FASD
Official title: Families Moving Forward Bridges: An Early Intervention Enhancement for Infants and Toddlers With Prenatal Alcohol Exposure With or At-risk for Fetal Alcohol Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2025-04-20
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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 with prenatal alcohol exposure (PAE) or FASD and their caregivers. FMF Bridges was developed by this research team and is adapted from a scientifically-validated positive parenting intervention (Families Moving Forward) shown to be efficacious with preschool and school-aged children affected by PAE or FASD. FMF Bridges merges key components of FASD-informed care with family-centered and relationship-based early intervention practices and is designed to be delivered in community-based early intervention programs. The FMF Bridges early intervention needs to be tested with children and families in the community-based early intervention settings for which it was designed. The study team plans to evaluate the feasibility of FMF Bridges in a small community trial. the team will partner with an early intervention program that has a high population of children with prenatal alcohol exposure. EI providers will be trained as FMF Bridges Specialists and deliver the intervention to a total of 12 dyads (young child and their primary caregiver). Dyads will receive ten 60-minute manualized FMF Bridges intervention sessions over 3-5 months (approximately every other week) from community EI providers trained as FMF Bridges Specialists.

Primary Aim 1: Examine the feasibility of implementing the FMF Bridges early intervention in a community early intervention setting.

The study will focus on answering the questions: 1) Is it practical to implement the FMF Bridge intervention in a community EI setting? 2) Can the intervention be implemented with fidelity? 3) Is the intervention acceptable to providers and caregivers? and 4) What refinements might be needed to improve the feasibility of implementation?

Eligibility criteria: Inclusion Criteria:

* Child inclusion criteria: Infants and toddlers 6-36 months of age, any gender, any race/ethnicity, who:

  1. have confirmed PAE as ascertained by the standard child development center intake procedures;
  2. 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:

1. biological, foster, adoptive, or other legal guardian;
2. age 18 or older;
3. any gender.

Exclusion Criteria:

* Child exclusion criteria:

  1. 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;
  2. 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;
  3. multiple birth;
  4. 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);
  5. child diagnosis of a known genetic or non-FASD neurodevelopmental condition (e.g., Down syndrome, autism spectrum disorder).

Primary outcomes:
measure: Devereux Early Childhood Assessment-Infant/Toddler (DECA-IT)
timeFrame: From enrollment to the end of intervention 3-5 months
measure: Parenting Interactions with Children - Checklist of Observations Linked to Outcomes (PICCOLO) 86
timeFrame: From enrollment to the end of intervention 3-5 months
measure: Family Outcomes Survey - Revised (FOS-R)
timeFrame: From enrollment to the end of intervention 3-5 months
measure: Healthy Families Parenting Inventory (HFPI)
timeFrame: From enrollment to the end of intervention 3-5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shoreline
country: United States
facility: Wonderland Child Development Center
state: Washington
Study officials:
affiliation: University of Washington
name: Tracy Jirikowic, PhD
role: PRINCIPAL_INVESTIGATOR
References: