NCT05176808

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

Telehealth Parent-Implemented Intervention to Improve Social- Communication Outcomes in Young Children With ASD

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Academic / Other
• Sex: All
• Age: 18 Months – 42 Months
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children 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 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 8-12 weeks. At the end of the intervention period, participants will be reassessed.

Conditions

• Autism Spectrum Disorder
• Autistic Disorder
• Active Autistic Disorder
• Autism
• Asperger Syndrome
• PDD-NOS
• Social Communication Delay
• Mixed Expressive Receptive Language Disorder
• Other Symbolic Dysfunctions

Interventions

Type	Name	Description
BEHAVIORAL	Early Achievements- Parent Coaching Intervention	Children, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles.

Timeline

• Start date: 2022-02-07
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2022-01-04
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States