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

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

Recruiting
18-33 years
All
Phase N/A

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Overview

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.

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.

Eligibility

Inclusion Criteria:

  • 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
    • 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.
    • Caregiver must conduct symptom screening prior to each research visit
    • Caregiver much wear a mask during visits

Exclusion Criteria:

  • Having a primary language other than English
  • Family lives >30 miles from a KKI-Center for Autism and Related Disorders(CARD) site (Baltimore; Odenton).
  • Receiving >15 hours of treatment per week at enrollment
  • Child lives in foster care.
  • Caregiver refusing to wear a mask during visits

Study details
    Autism Spectrum Disorder

NCT05176808

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

27 January 2024

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