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

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT05176808

Run by

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

People needed

117

Starts

2022-02-07

Expected to finish

2026-04-10

Last updated by the study team

2026-08-06

Who can join

Age: 2 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meeting study criteria for ASD based on:
• Autism Diagnostic Observation Schedule(ADOS) criteria for mild-to- moderate concern or greater (for children between 18 and 30 months) or algorithm cut-offs for ASD or autism (31-33 months),
• Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)( criteria for ASD)
• ASD diagnosis by clinician (clinical best estimate) by study team clinical research experts
• Meeting study criteria for social communication delay based on:
• Scoring a T score of <35 on Expressive Language and/or Receptive Language subscales, Nonverbal developmental quotient of > 50 (Visual Reception and Fine Motor subscales averaged) AND Visual reception > 12 months
• Nonverbal developmental quotient (DQ) of > 63 based on the Visual Reception and Fine Motor 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 (with eye contact or pairing vocalization and gesture) nonverbal or verbal communicative acts per day, with clear and specific examples, per parent report in the Eligibility Interview.

You may not qualify if…

• 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.

Where it is running

• Kennedy Krieger Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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