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

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

Status: Enrolling

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

Treatments: Behavioral: Early Achievements- Parent Coaching Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05176808

IRB00279093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 42 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 2 patient groups

Telehealth Parent Coaching (TC)

Active Comparator group

Description:

A family-centered, collaborative coaching approach, Practice-Based Coaching (Snyder et al., 2015), will be used. Coaches will use an NDBI coaching curriculum to support parents in targeting the child social-communication skills during interactions with their toddlers with ASD or social communication delays. The duration of the coaching period is 8-12 weeks with 2 sessions per week. Parents will be coached to implement NDBI strategies during daily routines with their young child with ASD or social communication delays following the coach and parent NDBI manuals developed in the primary principal investigator's lab. Trained study coaches will join families in their homes remotely via Kennedy Krieger Institute's secure Zoom password-protected account to provide coaching.

Treatment:

Behavioral: Early Achievements- Parent Coaching Intervention

In-person Coaching(IPC)

Active Comparator group

Description:

A family-centered, collaborative coaching approach, Practice-Based Coaching (Snyder et al., 2015), will be used. Coaches will use an NDBI coaching curriculum to support parents in targeting child social-communication skills during interactions with their toddlers with ASD or social communication delays. The duration of the coaching period is 8-12 weeks with sessions 2 times per week. Parents will be coached to implement NDBI strategies during daily routines with their young child with ASD following the coach and parent NDBI manuals developed in the primary principal investigator's lab. Coaching will be delivered in families' homes by trained study coaches to support parent implementation of NDBI strategies during daily life activities with their toddler with ASD or social communication delays.

Treatment:

Behavioral: Early Achievements- Parent Coaching Intervention