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

NCT ID: NCT05268796

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-05

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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In-person treatment

Group Type ACTIVE_COMPARATOR

Behavior therapy

Intervention Type 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.

Telehealth-enabled treatment

Group Type ACTIVE_COMPARATOR

Behavior therapy

Intervention Type 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

Group Type PLACEBO_COMPARATOR

Psychoeducation

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

Psychoeducation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Behavior Change Institute

UNKNOWN

Sponsor Role collaborator

United States Department of Defense

FED

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Scott Hall

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Stanford, California, United States

Site Status RECRUITING

Behavior Change Institute

Alamogordo, New Mexico, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Scott Hall, PhD

Role: CONTACT

650-498-4799

Facility Contacts

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Scott S Hall, phD

Role: primary

650-498-4799

Other Identifiers

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AR210221

Identifier Type: -

Identifier Source: org_study_id

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