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Recruiting NCT05268796

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

Phase II / Phase III Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavior therapy, Psychoeducation.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 2 years — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Frequency of challenging behavior [Time frame: 4 week intervals]
  • Parenting Stress Index [Time frame: Previous 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Stanford University — Stanford
  • Behavior Change Institute — Alamogordo

Identifiers

NCT: NCT05268796 · AR210221

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗