Expediting Access to Services for Equity

NCT06291246 | Terminated

• 2 other identifiers: 23-1823K12TR004416-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Time to initiation of autism specific intervention

  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).

  From enrollment to 6 months post.

Secondary Outcomes (6)

• 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

Study Arms (2)

Family Navigation

EXPERIMENTAL

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: Virtual Family Navigation

Educational Materials

ACTIVE COMPARATOR

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.

Behavioral: Educational Materials

Interventions

Virtual Family Navigation BEHAVIORAL

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.

Family Navigation

Educational Materials BEHAVIORAL

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.

Educational Materials

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Carolina Institute for Developmental Disabilities

Carrboro, North Carolina, 27510, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kelly Caravella, PhD

  UNC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: November 19, 2024
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 9 to 36 months following publication.
• Access Criteria: Investigator must have approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)