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

NCT ID: NCT05176808

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2026-09-01

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.

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Early Achievements- Parent Coaching Intervention

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

Early Achievements- Parent Coaching Intervention

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 42 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Landa, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Rachel Reetzke, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Kennedy Krieger Institute

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rebecca Landa, PhD

Role: CONTACT

landa@kennedykrieger.org

443-923-7591

Rachel Reetzke, PhD

Role: CONTACT

reetzke@kennedykrieger.org

443-923-7395

Facility Contacts

Rebecca Landa, PhD, CCC-SLP

Role: primary

landa@kennedykrieger.org

443-923-7632

Rachel Reetzke, PhD

Role: backup

reetzke@kennedykrieger.org

443-923-7395

References

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.

Reference Type: BACKGROUND

PMID: 26922192 (View on PubMed)

Other Identifiers

IRB00279093

Identifier Type: -

Identifier Source: org_study_id