Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With ASD

Randomized Controlled Trial of Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With Autism Spectrum Disorder

The purpose of the research is to determine whether parent-mediated behavior therapy for challenging behavior commonly displayed by children with autism spectrum disorder (ASD) can be as effective when delivered via telehealth as when delivered in-person.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Behavior therapy; Other: Psychoeducation

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Scott Hall, PhD; Phone Number: 650-498-4799; Email: hallss@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Principal Investigator: Scott S Hall, PhD
      • Contact: Scott S Hall, phD; Phone Number: 650-498-4799
  • New Mexico
    • Alamogordo, New Mexico, United States, 88310
      • Active, not recruiting
      • Behavior Change Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Child is aged 2 years 0 months to 7 years 11 months inclusive
2. Child has a documented diagnosis of ASD
3. Child exhibits at least one form of daily or hourly self-injurious behavior and/or aggressive behavior on the Behavior Problems Inventory - Short Form (BPI-S)71,72
4. Family lives in one of the following counties in New Mexico and Texas: Bernalillo, Santa Fe, Valencia, Sandoval, Torrance, Socorro, Cibola, Los Alamos, El Paso, Hudspeth, Otero, McKinley, San Miguel, Eddy, Chaves, or Dona Ana.
5. Caregiver is comfortable speaking and reading in English
6. The child's caregiver is at least 21 years old
7. The same caregiver is consistently available for one hour per week for a 12-week period in their home with their child between 9am and 7pm Monday through Friday to take part in the research
8. Caregiver is willing to adhere to the study intervention regimen and be willing to have a clinician come into their home for 1 hour per week for 12 weeks
9. Family lives in an area with consistent cell phone coverage

Exclusion criteria:

1. Caregiver is currently receiving ABA services or direct parent coaching to manage their child's challenging behaviors
2. Child engages in behavior that may inflict moderate to severe damage on the individual or on other people (e.g. biting through the skin, eye gouging, fracturing bones, significant damage to property) with minor or major medical intervention required.
3. Child has a sensory or physical impairment that precludes participation (e.g., epilepsy, vision or hearing impairment) or has a diagnosis of another genetic condition (e.g., fragile X syndrome)
4. Activity restrictions that limit caregiver's ability to respond to their child's challenging behaviors
5. Child has an underlying medical condition that is better treated with medical intervention
6. Child only exhibits pica at a daily or hourly frequency on the BPI-S
7. The caregiver has another child already participating in the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Psychoeducation	Other: Psychoeducation; Caregivers will complete online education modules in 1-hour sessions each week over 12 weeks.
Active Comparator: In-person treatment	Behavioral: Behavior therapy; Caregivers will be coached either in-person or via telehealth to implement function-based behavioral treatment in 1-hour sessions each week with their child over 12 weeks.
Active Comparator: Telehealth-enabled treatment	Behavioral: Behavior therapy; Caregivers will be coached either in-person or via telehealth to implement function-based behavioral treatment in 1-hour sessions each week with their child over 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting Stress Index	Severity of parent stress	Previous 4 weeks
Frequency of challenging behavior	In-session observations of challenging behavior	4 week intervals

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: United States Department of Defense; Behavior Change Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: AR210221

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