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Clinical Trials/NCT06291246
NCT06291246
Terminated
N/A

Expediting Enrollment Into Autism-specific Intervention for Black Toddlers: A Telehealth-based Family Navigation Approach

University of North Carolina, Chapel Hill1 site in 1 country33 target enrollmentNovember 19, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
University of North Carolina, Chapel Hill
Enrollment
33
Locations
1
Primary Endpoint
Time to initiation of autism specific intervention
Status
Terminated
Last Updated
9 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 19, 2024
End Date
July 7, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children up to 48 months who have a new diagnosis of autism, or who are waiting for a diagnosis of autism AND their caregiver.
  • Live in Georgia or North Carolina
  • Caregiver must be over the age of 18
  • Their child with autism must identify as Black/African-American
  • Speak conversationally fluent English.

Exclusion Criteria

  • No access to a telephone or internet connection for phone calls or video conferencing.
  • Diagnosis of autism spectrum disorder is ruled out in the child.

Outcomes

Primary Outcomes

Time to initiation of autism specific intervention

Time Frame: From enrollment to 6 months post.

The date of initiation (date 1) of autism-specific intervention will be the date that families report the first session with a therapist following the diagnosis (date 2). Time will be calculated as the number of days elapsed between these two dates (date 2 - date 1).

Secondary Outcomes

  • Caregiver Well-Being Score(6 months post enrollment)
  • Child's Developmental Functioning Score(18 months post enrollment)
  • Child's Adaptive Functioning Score(18 months post enrollment)
  • Appropriateness of Intervention Score(6 months after enrollment)
  • Feasibility of Intervention Score(6 months after enrollment)
  • Acceptability of Intervention Score(6 months after enrollment)

Study Sites (1)

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