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

Last updated: March 20, 2026
Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Asperger's Disorder

Communication Disorders

Treatment

Early Achievements- Parent Coaching Intervention

Clinical Study ID

NCT05176808
IRB00279093
  • Ages 18-42
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meeting study criteria for ASD based on:

  • Autism Diagnostic Observation Schedule(ADOS) criteria for mild-to- moderateconcern or greater (for children between 18 and 30 months) or algorithmcut-offs for ASD or autism (31-33 months),

  • Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)( criteria forASD)

  • ASD diagnosis by clinician (clinical best estimate) by study team clinicalresearch experts

  • Meeting study criteria for social communication delay based on:

  • Scoring a T score of <35 on Expressive Language and/or Receptive Languagesubscales, Nonverbal developmental quotient of > 50 (Visual Reception and FineMotor subscales averaged) AND Visual reception > 12 months

  • Nonverbal developmental quotient (DQ) of > 63 based on the Visual Reception and FineMotor subscales

  • Gestational age of 36-42 weeks;

  • Birth weight of > 2,500 grams;

  • Absence of identifiable neurological (e.g., epilepsy), genetic (e.g., Down syndrome,fragile X, tuberose sclerosis, neurofibromatosis) or severe sensory- motor (e.g.,cerebral palsy) conditions.

  • Able to walk independently.

  • Children must produce at least three different types of intentional directed (witheye contact or pairing vocalization and gesture) nonverbal or verbal communicativeacts per day, with clear and specific examples, per parent report in the EligibilityInterview.

Exclusion

Exclusion Criteria:

  • Having a primary language other than English

  • Family lives >40 miles from a Kennedy Krieger Institute-Center for Autism Services,Sciences, and Innovation (CASSI) site.

  • Child lives in foster care.

Study Design

Total Participants: 188
Treatment Group(s): 1
Primary Treatment: Early Achievements- Parent Coaching Intervention
Phase:
Study Start date:
February 07, 2022
Estimated Completion Date:
December 01, 2026

Study 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.

Connect with a study center

  • Kennedy Krieger Institute

    Baltimore, Maryland 21211
    United States

    Active - Recruiting

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