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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176808
• Other study ID #: IRB00279093
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2023
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: Rebecca Landa, PhD
• Phone: 443-923-7591
• Email: landa[@]kennedykrieger.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth delivered NDBI parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with ASD.

Description:

The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth delivered NDBI 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 12 weeks. At the end of the twelve weeks, participants will be reassessed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: January 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 33 Months

Eligibility

Inclusion 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

• 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.

• Caregiver must conduct symptom screening prior to each research visit

• Caregiver much wear a mask during visits

Exclusion Criteria:

• Having a primary language other than English

• Family lives >30 miles from a KKI-Center for Autism and Related Disorders(CARD) site (Baltimore; Odenton).

• Receiving >15 hours of treatment per week at enrollment

• Child lives in foster care.

• Caregiver refusing to wear a mask during visits

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Johns Hopkins Bloomberg School of Public Health, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Duration of Joint Attention	10 minute caregiver/child play samples will be coded using Adamson's 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.	12 weeks
Primary	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(NDBIs) (Bruinsma, 2020), 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.	12 weeks