Recruiting

Family Navigation

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07086781

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Not accepted

Interventions

Virtual Family Navigation

Educational Materials

Study Details

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 toddlers under the age of 4 living in Rural NC 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 rural 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

Study ID

NCT07086781

Start date

Jul 19, 2025

Status verified date

Oct, 2025

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children up to 48 months who have a new diagnosis of autism (within the last month) or who are waiting for a diagnosis of autism AND their caregiver.
  • Live in North Carolina, in one of the 78 rural counties.
  • Caregiver must be over the age of 18
  • The caregiver must 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Educational Materials

The comparison condition ("Educational Materials") consists of providing the child's caregivers with 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.

Interventions

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.

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.

Primary outcome measure

  • Time to initiation of autism specific intervention [ Time Frame: Diagnosis to 18 months post ]

Central Contacts and Locations

Central contacts

Kelly E Caravella, PhD

203-524-4349kelly_caravella@med.unc.edu

Locations

Carolina Institute for Developmental Disabilities

Recruiting

Carrboro, North Carolina, United States, 27510

Contacts

Kelly Caravella, PhD

2035244349kelly_caravella@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-10-29.