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Expediting Access to Services for Equity

NCT06291246 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-07-24

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Virtual Family Navigation

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.

BEHAVIORAL

Educational Materials

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.

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Kelly Caravella, PhD · UNC

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2025-07-07
Completion
2025-07-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06291246 on ClinicalTrials.gov