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NCT Number: NCT05268796

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

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.

Recruiting

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Key information

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Stanford University, Stanford, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Psychoeducation

Other

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

Primary outcomes

  1. Frequency of challenging behavior

    Time frame: 4 week intervals

    In-session observations of challenging behavior

  2. Parenting Stress Index

    Time frame: Previous 4 weeks

    Severity of parent stress

Study contacts

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

Scott Hall, PhD

CONTACT

[email protected]

650-498-4799

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Behavior Change Institute
  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2022
Registry last updated
Aug 27, 2024

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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