Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)
August 4, 2026 updated by: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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
Completed
Conditions
Intervention / Treatment
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 (Actual)
117
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21211
- Kennedy Krieger Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
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Children, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles.
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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.
|
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
Time Frame: 8-12 weeks
|
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.
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8-12 weeks
|
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Parent Fidelity of Implementation
Time Frame: 8-12 weeks
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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.
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8-12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2022
Primary Completion (Actual)
April 10, 2026
Study Completion (Actual)
April 10, 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)
August 6, 2026
Last Update Submitted That Met QC Criteria
August 4, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
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