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

NCT05176808 | Recruiting

• 1 other identifier: IRB00279093
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Social Communication; Language; Engagement

Outcome Measures

Primary Outcomes (2)

• Child Duration of Joint Attention

  10 minute caregiver/child play samples will be coded using an engagement coding schema. The schema differentiates different levels of engagement. This data will be used to compare duration of engagement states at pre- and post-testing.

  8-12 weeks

• Parent Fidelity of Implementation

  Parent fidelity of implementation will be coded from the parent-child interaction sample obtained within the home at baseline and post-intervention by trained (to reliability) research assistants blind to group membership and timing of sample. This form consists of 26-items, where each item is rated using a 3-point Likert-type scale. Items reflect the key elements of Natural Developmental Behavioral Interventions (NDBI) which have been assessed in parent-implemented NDBI studies found to improve child social-communication outcomes. Ratings are based on effectiveness (well-timed, variety, developmental appropriateness) and frequency/consistency.

  8-12 weeks

Study Arms (2)

Telehealth Parent Coaching (TC)

ACTIVE COMPARATOR

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.

Behavioral: Early Achievements- Parent Coaching Intervention

In-person Coaching(IPC)

ACTIVE COMPARATOR

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.

Behavioral: Early Achievements- Parent Coaching Intervention

Interventions

Early Achievements- Parent Coaching Intervention BEHAVIORAL

Children, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles.

In-person Coaching(IPC); Telehealth Parent Coaching (TC)

Eligibility Criteria

• Age: 18 Months - 42 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• United States Department of Defense: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

RECRUITING

Related Publications (1)

• Ingersoll B, Wainer AL, Berger NI, Pickard KE, Bonter N. Comparison of a Self-Directed and Therapist-Assisted Telehealth Parent-Mediated Intervention for Children with ASD: A Pilot RCT. J Autism Dev Disord. 2016 Jul;46(7):2275-84. doi: 10.1007/s10803-016-2755-z.

  PMID: 26922192 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Asperger Syndrome; Communication; Language

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Rebecca Landa, PhD

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

  PRINCIPAL INVESTIGATOR

• Rachel Reetzke, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Landa, PhD

CONTACT

443-923-7591; landa@kennedykrieger.org

Rachel Reetzke, PhD

CONTACT

443-923-7395; reetzke@kennedykrieger.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All participants will receive the same outcome battery of assessments. The individual evaluating the child and all coders will be blind to condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Upon confirmation of eligibility and completion of the baseline assessments, participants will be randomly assigned to the TC or IPC study condition. Randomization will be done in randomly permuted groups of different sizes to reduce predictability of treatment assignment, with one half of the parent-child dyads in each block assigned to the IPC arm and one half assigned to the TC condition.

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 4, 2022
• Study Start: February 7, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)