Resources for Optimizing Outcomes in Toddlers on the Spectrum

Official title

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

Overview

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.

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.

Primary outcome measures

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

Secondary outcome measures (6)

• Caregiver Well-Being Score [Time frame: 6 months post diagnosis]
• Change in Raw Scores on Visual Reception domain of the MSEL [Time frame: Baseline and 18 months post diagnosis]
• Change in Raw Scores on Expressive Language domain of the MSEL [Time frame: Baseline and 18 months post diagnosis]
• Change in Raw Scores on Receptive Language domain of the MSEL [Time frame: Baseline and 18 months post diagnosis]
• Change in Raw Scores on Fine Motor domain of the MSEL [Time frame: Baseline and 18 months post diagnosis]
• Change in Raw Scores on ABAS-3 Conceptual, Social and Practical Domains [Time frame: Baseline and 18 months post diagnosis]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Carolina Institute for Developmental Disabilities — Carrboro

Identifiers

NCT: NCT07086781 · 25-1164

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗