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

NCT05268796 | Recruiting Phase 2

• 1 other identifier: AR210221
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Frequency of challenging behavior

  In-session observations of challenging behavior

  4 week intervals

• Parenting Stress Index

  Severity of parent stress

  Previous 4 weeks

Study Arms (3)

In-person treatment

ACTIVE COMPARATOR

Behavioral: Behavior therapy

Telehealth-enabled treatment

ACTIVE COMPARATOR

Behavioral: Behavior therapy

Psychoeducation

PLACEBO COMPARATOR

Other: Psychoeducation

Interventions

Behavior therapy BEHAVIORAL

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.

In-person treatment; Telehealth-enabled treatment

Psychoeducation OTHER

Caregivers will complete online education modules in 1-hour sessions each week over 12 weeks.

Psychoeducation

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child is aged 2 years 0 months to 7 years 11 months inclusive
• Child has a documented diagnosis of ASD
• 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
• 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.
• Caregiver is comfortable speaking and reading in English
• The child's caregiver is at least 21 years old
• 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
• 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
• Family lives in an area with consistent cell phone coverage

You may not qualify if:

• Caregiver is currently receiving ABA services or direct parent coaching to manage their child's challenging behaviors
• 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.
• 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)
• Activity restrictions that limit caregiver's ability to respond to their child's challenging behaviors
• Child has an underlying medical condition that is better treated with medical intervention
• Child only exhibits pica at a daily or hourly frequency on the BPI-S
• The caregiver has another child already participating in the study

Sponsors & Collaborators

• Stanford University: lead
• Behavior Change Institute: collaborator
• United States Department of Defense: collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Behavior Change Institute

Alamogordo, New Mexico, 88310, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Scott Hall, PhD

CONTACT

650-498-4799; hallss@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 7, 2022
• Study Start: January 5, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)