Families Moving Forward Bridges for FASD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Visual impairment, Hearing impairment, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 3-5 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a positive parenting program called Families Moving Forward Bridges, designed for young children with Fetal Alcohol Spectrum Disorders (FASD) and their caregivers. The goal is to assess how well the program supports families and improves development in children exposed to alcohol before birth. Eligible participants are infants and toddlers aged 6-36 months in King County, WA, with developmental delays and confirmed prenatal alcohol exposure. The study involves 10 sessions, each lasting 60 minutes, held weekly or bi-weekly, to determine if this approach aids in the child's development. As an unphased trial, this study offers families a unique opportunity to contribute to research that could enhance developmental support for children with FASD.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Families Moving Forward Bridges intervention is safe for young children with FASD?

Research has shown that the Families Moving Forward (FMF) Bridges program offers promising early support for children with Fetal Alcohol Spectrum Disorders (FASD). In one past study, a year-long community program involving 19 young women with FASD led to significant improvements in their lives, suggesting that the program could be both helpful and well-received by participants.

As the FMF Bridges program is an early support initiative rather than a drug or medical treatment, no reports of physical side effects have emerged. The program focuses on providing support and strategies for caregivers and children, which is generally considered safe. While individual experiences may vary, current studies present a positive view of the program’s safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Families Moving Forward (FMF) Bridges program because it offers a personalized, home-based intervention for families dealing with Fetal Alcohol Spectrum Disorders (FASD). Unlike standard therapies that often take place in clinical settings, FMF Bridges provides ten tailored, hour-long sessions in the comfort of the family's home, making it more accessible and convenient. This approach not only facilitates better engagement but also allows for real-life application of strategies, potentially leading to more meaningful and sustained improvements in family dynamics and child behavior.

What evidence suggests that the FMF Bridges intervention is effective for FASD?

Research shows that the Families Moving Forward (FMF) Bridges program is designed to help children with Fetal Alcohol Spectrum Disorders (FASD) and their families. In a previous study, young women with FASD experienced significant improvements in their lives after joining a similar community program. The FMF Bridges program, which participants in this trial will receive, uses care specifically tailored for FASD and focuses on family-centered strategies to strengthen family bonds and support early child development. Early results suggest that this approach helps improve outcomes for children affected by alcohol exposure before birth. Although specific data on the program's effectiveness is still being collected, it is based on proven methods and shows promising potential. ^{1 4 6 7 8}

Who Is on the Research Team?

Tracy Jirikowic, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for infants and toddlers aged 6-36 months with prenatal alcohol exposure (PAE) who qualify for early intervention services due to developmental delays. Caregivers must be the legal guardian, over 18, and plan to stay in King County, WA. Children with severe medical conditions or other neurodevelopmental disorders are not eligible.

Inclusion Criteria

My child is 6-36 months old, has prenatal alcohol exposure, and qualifies for early intervention due to developmental delays.

Exclusion Criteria

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 month

1 visit (in-person)

Baseline Assessment

Baseline assessment session completed for caregiver and child

1 month

1 visit (in-person)

Treatment

Participants receive FMF Bridges intervention sessions from trained specialists

3-5 months

10 visits (in-person, weekly or bi-weekly)

Follow-up

Participants are monitored for outcomes immediately post-intervention

1 month

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Families Moving Forward Bridges

Trial Overview The study tests 'Families Moving Forward Bridges', a positive parenting program adapted for young children with Fetal Alcohol Spectrum Disorders (FASD). It's an unblinded feasibility study involving 12 child-caregiver pairs to see how well the intervention works.

How Is the Trial Designed?

Group I: FMF Bridges Early Intervention Program Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

A consensus symposium with 60 experts highlighted the need for improved integration of care for individuals with Fetal Alcohol Spectrum Disorder (FASD) across various systems, including health, education, and social services.

Key recommendations include increasing training and awareness among providers, implementing multidisciplinary care models, and utilizing accessible electronic medical records to enhance collaboration and improve outcomes for those affected by FASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating care for individuals with FASD: results from a multi-stakeholder symposium. Masotti, P., Longstaffe, S., Gammon, H., et al.[2018]

The FMF Connect app, designed to support caregivers of children with fetal alcohol spectrum disorders (FASD), was found to be feasible and acceptable, with 84% of caregivers and 94% of providers successfully installing the app during beta testing with 45 participants.

Caregivers engaged positively with the app, averaging 20 minutes of use per session, primarily benefiting from the Learning Modules, which provided valuable information and practical support, while also highlighting areas for technical improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Feasibility of the "Families Moving Forward Connect" Mobile Health Intervention for Caregivers of Children With Fetal Alcohol Spectrum Disorders: Mixed Method Evaluation Within a Systematic User-Centered Design Approach. Petrenko, CLM., Kautz-Turnbull, CC., Roth, AR., et al.[2022]

A 12-month community intervention involving 19 young women with Fetal Alcohol Spectrum Disorders (FASD) led to significant improvements in their lives, including reduced substance use and increased access to healthcare services.

The intervention's success was attributed to targeted education and collaboration with service providers, along with the support of paraprofessional advocate case managers, highlighting the importance of community-based approaches in addressing FASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot community intervention for young women with fetal alcohol spectrum disorders. Grant, T., Huggins, J., Connor, P., et al.[2019]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11169717

Families Moving Forward Bridges: An Early ... - NIH RePORTER Our research team has developed the Families Moving Forward (FMF) Bridges early intervention for infants and toddlers affected by PAE or with FASD and their ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06935461

Families Moving Forward Bridges: An Early Intervention for ... This is an initial feasibility study to examine Families Moving Forward Bridges (FMF Bridges), an FASD-informed early intervention designed to meet the ...

3. withpower.com withpower.com/trial/families-moving-forward-bridges-for-fasd-e40ab

Families Moving Forward Bridges for FASD A 12-month community intervention involving 19 young women with Fetal Alcohol Spectrum Disorders (FASD) led to significant improvements in their lives, ...

4. trial.medpath.com trial.medpath.com/clinical-trial/9d7cf1b170d3da55/early-intervention-infants-prenatal-alcohol-exposure

Families Moving Forward Bridges: An Early Intervention for ... FMF Bridges merges key components of FASD-informed care with family-centered and relationship-based early intervention practices and is designed to be delivered ...

5. familiesmovingforwardprogram.org familiesmovingforwardprogram.org/?page_id=4465

A Qualitative Study on the Experiences of Parents of Young ... The Best Possible Start: A Qualitative Study on the Experiences of Parents of Young Children With or At Risk for Fetal Alcohol Spectrum Disorders – Pruner et al.

6. familiesmovingforwardprogram.org familiesmovingforwardprogram.org/?page_id=3851

Resources for Clinicians ... Families Moving Forward Bridges: An Early Intervention Enhancement for Infants and Toddlers with PAE with or at-risk for Fetal Alcohol Spectrum Disorders. PI ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10976513/

Larger-scale feasibility trial of the families moving forward ... This single-arm feasibility trial assesses the Families Moving Forward (FMF) Connect app to determine readiness for a larger randomized controlled trial (RCT).

8. fasdunited.org fasdunited.org/wp-content/uploads/2025/03/PAAG_March14.pdf

FETAL ALCOHOL SPECTRUM DISORDERS Families Moving Forward Bridges— an early intervention model for young children with prenatal alcohol exposure with or at risk for. FASD and ...