Family Service Navigation for Autism

Overseen By Meghan Burke, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University

Disqualifiers: Not meeting inclusion criteria

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 9 months

55 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to develop and test a family navigator training and an app (a technology-based treatment support system) for low-resourced families of young children (aged 3-5) with autism. The hypothesis is that the navigator training and treatment support system will help enable navigators to support families of young children with autism in accessing needed services.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on training and support for families, so it's unlikely that medication changes are required.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Family Service Navigator Program treatment for autism?

Research shows that family navigation services can help families of children with autism access necessary services more effectively, improve family functioning, and reduce caregiver strain. These services have been found to be particularly beneficial for low-income and minority families, helping them overcome barriers to care and improving their knowledge and advocacy skills. ^{1 2 3 4 5}

What data supports the effectiveness of the Family Service Navigator Program for autism?

Research shows that family navigation services can help families of children with autism access necessary services more effectively, improve family functioning, and reduce caregiver strain. These services have been found to be particularly beneficial for low-income and minority families, helping them overcome barriers to care and improving their knowledge and advocacy skills. ^{1 2 3 4 5}

Is the Family Service Navigation for Autism safe for participants?

The available research on Family Navigation services for autism does not report any safety concerns or adverse effects, suggesting it is generally safe for participants. ^{2 3 4 5 6}

Is the Family Service Navigation for Autism safe for participants?

The research on Family Navigation services for autism does not report any safety concerns, indicating it is generally safe for participants. ^{2 3 4 5 6}

How is the Family Service Navigator Program different from other autism treatments?

The Family Service Navigator Program is unique because it focuses on helping families navigate complex systems to access autism services, providing personalized support and creating a shared action plan with caregivers, rather than directly treating autism symptoms. ^{2 3 4 5 7}

How is the Family Service Navigator Program different from other autism treatments?

The Family Service Navigator Program is unique because it focuses on helping families navigate complex systems to access autism services, rather than directly treating autism symptoms. It provides personalized support and creates a shared action plan with families to improve access to care and reduce caregiver stress, which is different from traditional medical or behavioral therapies. ^{2 3 4 5 7}

Research Team

Meghan Burke, PhD

Principal Investigator

Vanderbilt University

Eligibility Criteria

This trial is for English-speaking parents, aged 18 or older, from low-resourced communities. They must have a young child (aged 3-5) with autism and want help navigating service systems. Participants need to own or be provided a phone compatible with the treatment support app.

Inclusion Criteria

Own a phone which can use the treatment support system (or be provided a phone from the Public Assistance Office or from the grant)

-Individuals who do not meet all inclusion criteria are by definition excluded.

I am 18 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive support from a Family Service Navigator and access to a Treatment Support System

9 months

At least 2 meetings with the navigator

Follow-up

Participants are monitored for changes in social responsiveness, adaptive behavior, knowledge, skills, advocacy, empowerment, and parenting self-efficacy

9 months

Surveys at 3, 6, and 9 months

Treatment Details

Interventions

• Family Service Navigator Program

Trial Overview The study is evaluating a program where trained Family Service Navigators use an app to assist families in accessing services for children with autism. It aims to see if this support improves service access for these families.

Participant Groups

Group I: Intervention Group (Access to an FSN/TSS) Experimental Treatment 1 Intervention

40 participants will be randomly assigned to the intervention group (i.e., to receive an FSN and have access to the TSS). The FSN may meet with the participant at least twice and provide navigation support.

Group II: Control Group (Access to Information, training and referral) Active Control 1 Intervention

15 participants will be randomly assigned to the non-personalized comparison group (i.e., information, training, and referral).

Family Service Navigator Program is already approved in United States for the following indications:

Approved in United States as Family Service Navigator Program for:

• Support for families of young children with Autism Spectrum Disorder

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials

714

Recruited

6,143,000+

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials

203

Recruited

40,600+

Findings from Research

This study is testing the effectiveness of Patient Navigation (PN) as a strategy to improve access to evidence-based services for children with autism spectrum disorder (ASD), involving 250 families across multiple clinics in the northeastern U.S.

The trial aims to measure how PN affects the time it takes for families to receive a diagnosis and access recommended services compared to conventional care management, potentially revealing important insights into reducing disparities in care for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder. Broder-Fingert, S., Walls, M., Augustyn, M., et al.[2021]

The Family-Centered Autism Navigation semi-structured interview guide was developed to help family navigators prioritize caregiver concerns and create a shared navigation plan after a child's autism diagnosis, based on insights from 42 brief interviews and expert feedback.

This guide aims to enhance caregiver knowledge and skills in navigating services, ultimately improving access to care and supporting families in managing their child's autism spectrum disorder effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and utility of the Family-Centered Autism Navigation interview. Pizur-Barnekow, K., Lang, AC., Barger, B.[2021]

The SPANS program effectively improved the knowledge of 19 low-resourced parents about autism services, enhancing their ability to advocate for themselves and others.

The program showed high attendance and acceptability, indicating that it is a feasible and well-received approach to training navigators for families facing challenges in accessing services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the Effectiveness and Feasibility of a Family Navigator Program for Parents of Children With Autism. Burke, MM., Cheung, WC., Kim, J.[2023]

Modifications to the family navigation (FN) strategy significantly improved recruitment for the study, with a reduction in the number of families refusing or being excluded from participation (from 19.5% to 4.8% and 43.6% to 0%, respectively).

In the second pilot RCT, families were more likely to complete the diagnostic assessment and reported greater satisfaction with clinical care, with FN showing a continued benefit over usual care in increasing the likelihood of completing assessments (hazard ratio of 2.57).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Family Navigation for Children With Autism: A Comparison of Two Pilot Randomized Controlled Trials. Feinberg, E., Kuhn, J., Eilenberg, JS., et al.[2022]

Family navigation (FN) services for families of children with autism spectrum disorder (ASD) showed improvements in parent activation and reduced caregiver strain among 260 parents, indicating potential efficacy in supporting families.

However, the effectiveness of FN services varied significantly based on how they were implemented, including factors like timing and type of services, suggesting that tailored approaches may be necessary for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Families' Experiences With Family Navigation Services in the Autism Treatment Network. Crossman, MK., Lindly, OJ., Chan, J., et al.[2020]

The study identified five high-priority areas where Family Navigation for children with autism spectrum disorder could fail, including setting up community services and initial family meetings, based on expert evaluations from a mixed-methods approach involving 9 experts.

The most critical failure was found in 'setting up community-based services,' while 'attending testing appointments' was rated as the most severe potential failure, highlighting the need for targeted strategies to improve implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed-methods process evaluation of Family Navigation implementation for autism spectrum disorder. Broder-Fingert, S., Qin, S., Goupil, J., et al.[2020]

Family Navigation (FN) is an effective intervention for improving access to autism diagnostic services, particularly for low-income, racial, and ethnic minority families, as indicated by a nested qualitative study involving 21 parents and 7 navigators.

Participants proposed 38 adaptations to FN, mainly focusing on enhancing the content and implementation of the intervention, which could help tailor FN to better meet the needs of diverse families and improve health equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for post-implementation adaptations to optimize family navigation in pediatric primary care: a qualitative study with parents and navigators. Levinson, J., Hickey, E., Fuchu, P., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

A hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder. [2021]

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

Development and utility of the Family-Centered Autism Navigation interview. [2021]

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

Understanding the Effectiveness and Feasibility of a Family Navigator Program for Parents of Children With Autism. [2023]

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

Improving Family Navigation for Children With Autism: A Comparison of Two Pilot Randomized Controlled Trials. [2022]

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

Families' Experiences With Family Navigation Services in the Autism Treatment Network. [2020]

6. England pubmed.ncbi.nlm.nih.gov

A mixed-methods process evaluation of Family Navigation implementation for autism spectrum disorder. [2020]

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

Recommendations for post-implementation adaptations to optimize family navigation in pediatric primary care: a qualitative study with parents and navigators. [2023]