Resources for Optimizing Outcomes in Toddlers on the Spectrum

NCT07086781 | Recruiting

• 1 other identifier: 25-1164
• Study Type: interventional
• Target: 60
• 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 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

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).

  Diagnosis to 18 months post

Secondary Outcomes (6)

• Caregiver Well-Being Score

  6 months post diagnosis

• Change in Raw Scores on Visual Reception domain of the MSEL

  Baseline and 18 months post diagnosis

• Change in Raw Scores on Expressive Language domain of the MSEL

  Baseline and 18 months post diagnosis

• Change in Raw Scores on Receptive Language domain of the MSEL

  Baseline and 18 months post diagnosis

• Change in Raw Scores on Fine Motor domain of the MSEL

  Baseline and 18 months post diagnosis

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 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.

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 (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.

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
• The Foundation of Hope for Research and Treatment of Mental Illness: collaborator

Study Sites (1)

Carolina Institute for Developmental Disabilities

Carrboro, North Carolina, 27510, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kelly Caravella, PhD

  Carolina Institute for Developmental Disabilities

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly E Caravella, PhD

CONTACT

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

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: July 18, 2025
• First Posted: July 25, 2025
• Study Start: July 19, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 29, 2025

Record last verified: 2025-10

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)