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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new family service navigator program and a supportive app designed to help families of young children with autism access necessary services. The researchers aim to determine if the program can effectively assist families who struggle to find and use available resources. Families with children aged 3-5 who have autism and come from low-resourced communities may be suitable for this trial. Participants will either work with a trained navigator or receive general information and referrals. As an unphased trial, this study provides families the chance to contribute to innovative solutions that could significantly enhance access to autism 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 prior data suggests that the Family Service Navigator Program is safe for families of young children with autism?

Research shows that family navigation programs for children with autism are well-received and yield positive results. These programs assist families in accessing essential services and support early autism diagnoses. Previous studies have found these programs particularly effective for low-income and ethnic minority families.

The programs provide training in communication and problem-solving, enabling navigators to better support families. No negative effects have been reported in these studies, indicating that the program is safe and well-tolerated by participants.

Since this study aims to develop and test a similar program, existing evidence suggests it is likely safe for participating families. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Service Navigator Program because it offers a personalized approach to supporting families dealing with autism. Unlike standard care options that often include generalized information and referrals, this program provides direct access to a Family Service Navigator (FSN) who meets with families at least twice. The FSN offers tailored navigation support, potentially making it easier for families to access the specific services they need. This hands-on, customized assistance is what sets this program apart and could make a significant difference in managing autism-related challenges.

What evidence suggests that the Family Service Navigator Program is effective for supporting families of young children with autism?

Research shows that family navigator programs positively impact families of children with autism. These programs assist families, particularly those with lower incomes or from ethnic minority groups, in obtaining early autism diagnoses. Studies have found that families using these programs often access the autism services they need more easily. This trial will compare two groups: one group will receive personalized support through the Family Service Navigator Program, which may help families understand and manage the complex world of autism services. The other group will have access to information, training, and referral services. This support can significantly help families connect with the right resources. ^{1 3 4 5 6}

Who Is on the Research Team?

Meghan Burke, PhD

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

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 the parent of a child older than 5 with autism.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. publications.aap.org publications.aap.org/pediatrics/article/155/4/e2024067947/201180/Family-Navigation-Programs-for-Children-With

Family Navigation Programs for Children With Autism ... This scoping review aimed to map the current evidence to describe the characteristics and synthesize the effectiveness of FN programs for children with ASD.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01340092?term=family%20Navigation&cond=Autism&country=United%20States&state=Massachusetts&locStr=Massachusetts,%20United%20States&viewType=Table&rank=1

Study Details | NCT01340092 | Use of a Family Navigator ... A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A group or subgroup ...

3. withpower.com withpower.com/trial/phase-child-development-disorders-pervasive-6-2022-a3b58

Family Service Navigation for Autism · Info for Participants 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 ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05099705/testing-a-family-service-navigator-program-for-low-resourced-families-of-young-children-with-autism-spectrum-disorder

Testing a Family Service Navigator Program for Low- ... The purpose of this study is to develop and test a family navigator training and an app (a technology-based treatment support system) for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10637767/

Understanding the Effectiveness and Feasibility of a Family ... Family navigator programs have demonstrated positive outcomes such as early autism diagnoses among low-income and ethnic minority families (Feinberg, Augustyn ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8723795/

Family navigation to increase evaluation for autism ... The AFNs completed standard navigator training, including interpersonal communication, problem-solving skills, motivational interviewing, and navigation (e.g., ...