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

24 Participants Needed

Trial Summary

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 data supports the effectiveness of the Families Moving Forward Bridges treatment for FASD?

Research on similar family-based interventions for FASD, like the Families on Track and Coaching Families programs, shows positive effects on child and caregiver outcomes, including reduced caregiver stress and improved family functioning. These findings suggest that family-focused treatments can be effective in supporting families dealing with FASD. ^{1 2 3 4 5}

How is the Families Moving Forward Bridges treatment different from other treatments for FASD?

Families Moving Forward Bridges is unique because it focuses on improving accessibility to FASD-informed care through a mobile health intervention for caregivers, which includes components like learning modules and a family forum, making it more scalable and user-friendly compared to traditional in-person therapies. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Tracy Jirikowic, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A pilot community intervention for young women with fetal alcohol spectrum disorders. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Integrating care for individuals with FASD: results from a multi-stakeholder symposium. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Six-Month Follow-up of the Families on Track Intervention Pilot Trial for Children With Fetal Alcohol Spectrum Disorders and Their Families. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of a community-based intervention for parents with FASD. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The impact of fetal alcohol spectrum disorders on families: evaluation of a family intervention program. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

Usability Testing of Guided Internet-based Parent Training for Challenging Behavior in Children with Fetal Alcohol Spectrum Disorder (Strongest Families FASD). [2020]

7. England pubmed.ncbi.nlm.nih.gov

Experiences of living with fetal alcohol spectrum disorders: a systematic review and synthesis of qualitative data. [2018]

8. Canada 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

"Family matters:" fetal alcohol spectrum disorders and the family. [2013]

10. Australia pubmed.ncbi.nlm.nih.gov

Development of a referral pathway framework for foetal alcohol spectrum disorder in the Pilbara. [2021]