Clinical Trial

Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)

Completed
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Summary
The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD or social communication delays by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with either a social communication delay or ASD.
Protocol Amendment History 4 changes
critical Trial completed 2026-08-07
notable Enrollment reduced: 188 -> 117 participants 2026-08-07
notable Primary completion moved earlier: 2026-06-01 -> 2026-04-10 2026-08-07
minor Completion moved earlier: 2026-12-01 -> 2026-04-10 2026-08-07
Trial Details
NCT Number NCT05176808
Lead Sponsor Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators: United States Department of Defense, Johns Hopkins Bloomberg School of Public Health
Conditions Autism Spectrum Disorder, Autistic Disorder, Active Autistic Disorder, Autism, Asperger Syndrome, PDD-NOS, Social Communication Delay, Mixed Expressive Receptive Language Disorder +1 more
Enrollment 117 participants
Start Date 2022-02-07
Primary Completion 2026-04-10 (estimated)
Study Completion 2026-04-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-06