Prenatal Alcohol ExposureNCT06935461
Families Moving Forward Bridges: An Early Intervention for Infants and Toddlers With PAE With or At-risk for FASD
A study testing Families Moving Forward Bridges in people with Prenatal Alcohol Exposure and Fetal Alcohol Spectrum Disorders, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Prenatal Alcohol Exposure, Fetal Alcohol Spectrum Disorders
- What is being tested?
- Families Moving Forward Bridges
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wonderland Child Development Center
Shoreline, Washington, 98177
About this study
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
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.
Read the 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?
- Being tested
- Families Moving Forward Bridges
- Keywords
- early childhood intervention, prenatal alcohol exposure, fetal alcohol spectrum disorder, infants and toddlers, FASD informed intervention
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Families Moving Forward BridgesBehavioural
Ten, 60-minute manualized FMF Bridges intervention sessions over 3-5 months (approximately every other week)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Families Moving Forward Bridges |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of intervention 3-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start18 Apr 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal Alcohol ExposureStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Tracy Jirikowic, University of Washington
- Investigators
- Tracy Jirikowic, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935461
- Sponsor's protocol ID
- STUDY00020599
- Other IDs
- 1R61AA031695-01
- Status last verified
- Jul 2025
- First submitted
- 14 Mar 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the statistical analysis plan. We will not share informed consent or study protocol because this is a feasibility study with a small sample.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06935461
- Acronym / sponsor ID
- STUDY00020599
- Keywords
- early childhood intervention, prenatal alcohol exposure, fetal alcohol spectrum disorder, infants and toddlers, FASD informed intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMF Bridges Early Intervention Program | Other | Behavioral: Families Moving Forward BridgesFollowing 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 |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Child inclusion criteria: Infants and toddlers 6-36 months of age, any gender, any race/ethnicity, who:
- biological, foster, adoptive, or other legal guardian;
- age 18 or older;
- any gender.
Key exclusion criteria (6 listed)
- Child exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Families Moving Forward BridgesTen, 60-minute manualized FMF Bridges intervention sessions over 3-5 months (approximately every other week) | Behavioural | FMF Bridges Early Intervention Program |
Primary outcome
Devereux Early Childhood Assessment-Infant/Toddler (DECA-IT)
Time frame: From enrollment to the end of intervention 3-5 months
Standardized parent rating scale assessing child initiative, attachment, and self-regulation. Internal consistency (α=.90-.94); test-retest reliability (r= .91-.99).
Parenting Interactions with Children - Checklist of Observations Linked to Outcomes (PICCOLO) 86
Time frame: From enrollment to the end of intervention 3-5 months
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).
Family Outcomes Survey - Revised (FOS-R)
Time frame: From enrollment to the end of intervention 3-5 months
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.
Healthy Families Parenting Inventory (HFPI)
Time frame: From enrollment to the end of intervention 3-5 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Yes. We will share the statistical analysis plan. We will not share informed consent or study protocol because this is a feasibility study with a small sample.
Related trials for Prenatal Alcohol Exposure
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Pilot Study of Prenatal Choline Supplementation
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RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tracy Jirikowic, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Families Moving Forward Bridges in people with Prenatal Alcohol Exposure and Fetal Alcohol Spectrum Disorders, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Devereux Early Childhood Assessment-Infant/Toddler (DECA-IT) (time frame: From enrollment to the end of intervention 3-5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.