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

Telehealth Parent-Implemented Intervention to Improve Social- Communication Outcomes in Young Children With ASD

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Autistic Disorder; Autism; Asperger Syndrome; PDD-NOS; Active Autistic Disorder; Social Communication Delay; Mixed Expressive Receptive Language Disorder; Other Symbolic Dysfunctions
• Intervention / Treatment: Behavioral: Early Achievements- Parent Coaching Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Landa, PhD; Phone Number: 443-923-7591; Email: landa@kennedykrieger.org
• Study Contact Backup: Name: Rachel Reetzke, PhD; Phone Number: 443-923-7395; Email: reetzke@kennedykrieger.org

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21211
      • Recruiting
      • Kennedy Krieger Institute
      • Contact: Rebecca Landa, PhD, CCC-SLP; Phone Number: 443-923-7632; Email: landa@kennedykrieger.org
      • Principal Investigator: Rebecca Landa, PhD, CCC-SLP
      • Contact: Rachel Reetzke, PhD; Phone Number: 443-923-7395; Email: reetzke@kennedykrieger.org
      • Principal Investigator: Rachel Reetzke, PhD, CCC-SLP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Telehealth Parent Coaching (TC); 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; Children, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles.
Active Comparator: In-person Coaching(IPC); 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; Children, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Collaborators: United States Department of Defense; Johns Hopkins Bloomberg School of Public Health
• Investigators: Principal Investigator: 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.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Language; Social Communication; Engagement
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Behavior; Autism Spectrum Disorder; Autistic Disorder; Asperger Syndrome; Communication; Language
• Other Study ID Numbers: IRB00279093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No