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NCT Number: NCT05176808

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

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Key information

Age range

18 month–42 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location status: Recruiting

Location contact

Rachel Reetzke, PhD

CONTACT

[email protected]

443-923-7395

Rachel Reetzke, PhD, CCC-SLP

PRINCIPAL_INVESTIGATOR

Rebecca Landa, PhD, CCC-SLP

CONTACT

[email protected]

443-923-7632

Rebecca Landa, PhD, CCC-SLP

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Parent Fidelity of Implementation

    Time frame: 8-12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Reetzke, PhD

CONTACT

[email protected]

443-923-7395

Rebecca Landa, PhD

CONTACT

[email protected]

443-923-7591

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Johns Hopkins Bloomberg School of Public Health
  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 4, 2022
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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