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Clinical Trial Summary

The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth delivered NDBI parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with ASD.


Clinical Trial Description

The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth delivered NDBI parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with ASD. The secondary hypothesis is that feasibility (defined as parent fidelity) of TC is non-inferior to IPC. An exploratory objective is to guide clinical decision-making for telehealth implementation by examining the heterogeneity of treatment response across the two treatment arms. The investigators will test the hypothesis that baseline child behavioral dysregulation, active engagement, developmental quotient, and parent stress moderate child social-communication outcomes. After completing eligibility testing, eligible children will be randomized into the TC or IPC condition. Each condition will involve twice weekly coaching sessions over 12 weeks. At the end of the twelve weeks, participants will be reassessed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05176808
Study type Interventional
Source Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Contact Rebecca Landa, PhD
Phone 443-923-7591
Email landa@kennedykrieger.org
Status Recruiting
Phase N/A
Start date February 7, 2022
Completion date January 1, 2026

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