Virtual Family Navigation for Autism

(EASE Trial)

Overseen By Kelly Caravella, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: No phone/internet, Autism ruled out

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for Black toddlers under the age of 4 after their initial diagnosis of autism. The main questions it aims to answer are: * Does Family Navigation decrease the time to initiation of intervention for Black toddlers with autism? * Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism? * Does Family Navigation improve caregiver well-being? Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom. Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care.

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the treatment Virtual Family Navigation for Autism?

Research shows that family navigation services can help families of children with autism by improving access to care and reducing the time to receive autism-related diagnostic services, especially for low-income and minority families. These services have been found to increase parents' knowledge about autism services and improve their ability to advocate for their children. ^{1 2 3 4 5}

Is Virtual Family Navigation for Autism safe for humans?

The research on Family Navigation for autism does not report any safety concerns, suggesting it is generally safe for humans. It focuses on helping families access care and navigate services, with no mention of harmful effects. ^{1 2 3 6 7}

How is the Virtual Family Navigation treatment for autism different from other treatments?

Virtual Family Navigation is unique because it focuses on helping families navigate the complex systems of care for children with autism by co-creating a personalized action plan with family navigators. This approach prioritizes the family's concerns and strengths, unlike traditional treatments that may not address the logistical and emotional challenges families face in accessing services. ^{1 2 3 4 8}

Research Team

Kelly Caravella, PhD

Principal Investigator

UNC

Eligibility Criteria

This trial is for Black caregivers of toddlers under age 3 who have recently been diagnosed with autism. It's designed to help them find and start community-based autism services quickly after diagnosis.

Inclusion Criteria

Caregiver of a child with a clinical diagnosis of autism spectrum disorder

Child with autism must be Black/African-American

Must speak conversationally fluent English

Exclusion Criteria

No access to a telephone or internet connection for phone calls or video conferencing

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Family Navigation

Caregivers receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All sessions are delivered virtually via phone/Zoom.

3 months

4 virtual sessions

Follow-up

Participants are monitored for developmental outcomes and caregiver well-being at 6 and 18 months post-enrollment.

18 months

Treatment Details

Interventions

• Virtual Family Navigation (Behavioral Intervention)

Trial Overview The study tests if Virtual Family Navigation (FN) can speed up the process of getting into autism programs compared to just receiving educational materials. FN involves four sessions via phone or Zoom with a trained navigator.

Participant Groups

Group I: Family Navigation Experimental Treatment 1 Intervention

Participants randomized to the Family Navigation condition will receive up to 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom.

Group II: Educational Materials Active Control 1 Intervention

The comparison condition ("Educational Materials") consists of providing the participant's caregivers information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. Families in this condition will receive this information throughout 4 timepoints in the first 3 months after enrolling.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Findings from Research

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 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]

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]

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]

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 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]

In a pilot study involving 40 families, the pediatric developmental passport significantly improved service contact rates for families of children with autism spectrum disorder (ASD), with 95% of the intervention group reaching out to services compared to 70% in the control group.

The passport was particularly effective in community clinics, where it helped 90% of families contact services, compared to only 40% in the control group, highlighting its potential to enhance service navigation in settings with limited specialist availability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Access to Developmental Services for Children with Autism Spectrum Disorder: The Pediatric Developmental Passport Pilot Randomized Trial. Young, E., Aiyadurai, R., Jegathesan, T., et al.[2021]

Parents of children with Medicaid who received early access to an Autism Patient Navigator (APN) found the assessment significantly more useful, indicating that the APN may enhance the support for families navigating autism services.

Children with early access to the APN were more successful in scheduling and completing appointments for necessary services, suggesting that timely support can improve access to care for children diagnosed with autism spectrum disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Autism Navigator on Access to Services. Roth, BM., Kralovic, S., Roizen, NJ., et al.[2019]

References

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

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

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

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

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

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

5. 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]

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

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

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

Increasing Access to Developmental Services for Children with Autism Spectrum Disorder: The Pediatric Developmental Passport Pilot Randomized Trial. [2021]

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

Impact of Autism Navigator on Access to Services. [2019]