Virtual Family Navigation for Autism

(EASE Trial)

Overseen By Kelly Caravella, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: No phone/internet, Autism ruled out

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual Family Navigation can help Black toddlers with autism begin treatment more quickly and enhance their development. It includes four one-on-one virtual sessions with a trained navigator who guides families in enrolling in early intervention services. Researchers aim to determine if this method is more effective than providing educational materials alone. Families with a Black child under 4 years old, newly diagnosed with autism and residing in Georgia or North Carolina, might be suitable candidates. Participants need access to a phone or internet for virtual sessions. As an unphased trial, this study offers families the chance to access potentially beneficial support early in their child's development.

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 prior data suggests that Virtual Family Navigation is safe for Black toddlers with autism?

Research shows that Family Navigation (FN) services for children with autism are generally well-received. Past studies have helped parents feel more prepared and confident in managing their child's condition. No significant safety concerns or negative effects have been reported with FN.

FN focuses on guiding and supporting families through virtual sessions with a trained navigator. These sessions help families understand and access early intervention services for their child. Since FN involves education and support rather than medical treatment, the risks remain very low. Studies suggest that FN is a safe and effective way to help families manage autism interventions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Family Navigation for autism because it offers personalized support in a convenient, virtual format. Unlike traditional methods, which often require in-person consultations and can be time-consuming, this approach provides families with up to four individualized sessions with a trained navigator via phone or Zoom. This makes it easier for families to access support and resources without the logistical challenges of travel. Additionally, by actively guiding families through the process of identifying and enrolling in early intervention services, this method aims to enhance engagement and outcomes for children with autism.

What evidence suggests that Virtual Family Navigation is effective for autism?

Research shows that Family Navigation (FN) programs, which participants in this trial may receive, can greatly assist children with autism and their families. Studies have found that FN services increase parental involvement in securing necessary autism support for their children. Evidence also indicates that FN reduces caregiver stress by providing clear guidance and support. Additionally, FN has successfully helped children from low-income and minority families receive earlier autism diagnoses and access services more easily. Overall, this approach promises to guide families through the complex world of autism support services. ^{1 2 4 5 6}

Who Is on the Research Team?

Kelly Caravella, PhD

Principal Investigator

UNC

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Family Navigation

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-2-2024-c86fe

Virtual Family Navigation for Autism (EASE Trial) Family navigation (FN) services for families of children with autism spectrum disorder (ASD) showed improvements in parent activation and reduced caregiver ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05910502

Project AFECT (Autism Family Empowerment Coaching ... This is a prospective clinical effectiveness study of Project AFECT, an intervention combining parent coaching and family navigation. Parents who meet inclusion ...

4. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2775015

Effect of Family Navigation on Diagnostic Ascertainment ... Family navigation is a promising approach to improve early ASD diagnosis among children from low-income, racial/ethnic minority families.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6742480/

A mixed-methods process evaluation of Family Navigation ... The aim of this study was to identify potential failures in implementing Family Navigation for children with autism spectrum disorder, using a failure modes and ...

6. amchp.org amchp.org/wp-content/uploads/2021/11/Final-issue-brief_3.12.pdf

Family Navigation Implementation Strategies: Improving ... The Autism Project has learned that it is critical to have navigators who are bilingual, because having support and receiving information in a family's native ...