Families Moving Forward Bridges: An Early Intervention for Infants and Toddlers With PAE With or … (NCT06935461) | Clinical Trial Compass
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 range
6 Months
Sex
ALL
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Devereux Early Childhood Assessment-Infant/Toddler (DECA-IT)
Timeframe: From enrollment to the end of intervention 3-5 months
2
Parenting Interactions with Children - Checklist of Observations Linked to Outcomes (PICCOLO) 86
Timeframe: From enrollment to the end of intervention 3-5 months
3
Family Outcomes Survey - Revised (FOS-R)
Timeframe: From enrollment to the end of intervention 3-5 months
4
Healthy Families Parenting Inventory (HFPI)
Timeframe: From enrollment to the end of intervention 3-5 months
. 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).