RECRUITING

Resources for Optimizing Outcomes in Toddlers on the Spectrum

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Expediting Access to Autism Specific Intervention for Young Autistic Children Living in Rural North Carolina: a Pilot Study

Quick Facts

Study Start:2025-07-19
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07086781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Live in North Carolina, in one of the 78 rural counties.
  3. * Caregiver must be over the age of 18
  4. * The caregiver must speak conversationally fluent English.
  1. * No access to a telephone or internet connection for phone calls or video conferencing.
  2. * Diagnosis of autism spectrum disorder is ruled out in the child.

Contacts and Locations

Study Contact

Kelly E Caravella, PhD
CONTACT
203-524-4349
kelly_caravella@med.unc.edu

Principal Investigator

Kelly Caravella, PhD
PRINCIPAL_INVESTIGATOR
Carolina Institute for Developmental Disabilities

Study Locations (Sites)

Carolina Institute for Developmental Disabilities
Carrboro, North Carolina, 27510
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Kelly Caravella, PhD, PRINCIPAL_INVESTIGATOR, Carolina Institute for Developmental Disabilities

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-19
Study Completion Date2028-07

Study Record Updates

Study Start Date2025-07-19
Study Completion Date2028-07

Terms related to this study

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder