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NCT05176808NARecruiting

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

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

Start Date

2/7/2022

Completion Date

12/1/2026

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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * 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. 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.

Interventions

BEHAVIORAL

Early Achievements- Parent Coaching Intervention

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Conditions

Autism Spectrum DisorderAutistic DisorderActive Autistic DisorderAutismAsperger SyndromePDD-NOSSocial Communication DelayMixed Expressive Receptive Language DisorderOther Symbolic Dysfunctions

Locations

Kennedy Krieger Institute

Baltimore, Maryland 21211

United States