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

Primary Purpose

Autism Spectrum Disorder

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Behavior therapy

Psychoeducation

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Child is aged 3 to 5 years inclusive
Child has a diagnosis of ASD (confirmed by diagnostic report)
Child is reported to exhibit challenging behavior on a daily basis according to the BPI-S
Child and participating parent/caregiver are English-speaking
The child's primary caregiver is safely able to physically manage their child's challenging behavior during the FA and treatment
The child's primary caregiver is available to implement the intervention over 12 weeks

Exclusion Criteria:

Child or caregiver has a neurological condition or sensory deficit that would preclude study participation
Parent/caregiver is currently receiving direct parent coaching with a BCBA to manage their child's challenging behaviors
Child is taking psychoactive medications for challenging behavior
Child currently receives more than 5 hours per week of focused or comprehensive behavioral treatment
Child engages in self-injury or aggression where exposure to the baseline conditions would place them or their caregiver at risk of serious or permanent harm

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

In-person treatment

Telehealth-enabled treatment

Psychoeducation

Arm Description

Outcomes

Primary Outcome Measures

Aberrant Behavior Checklist - Community

Severity of challenging behavior

Parenting Stress Index

Severity of parent stress

Secondary Outcome Measures

Full Information

NCT ID

NCT05268796

First Posted

February 15, 2022

Last Updated

April 12, 2022

Sponsor

Stanford University

Collaborators

Behavior Change Institute, United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT05268796

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 2022 (Anticipated)

Primary Completion Date

June 2026 (Anticipated)

Study Completion Date

June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Behavior Change Institute, United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

In-person treatment

Arm Type

Active Comparator

Arm Title

Telehealth-enabled treatment

Arm Type

Active Comparator

Arm Title

Psychoeducation

Arm Type

Placebo Comparator

Intervention Type

Behavioral

Intervention Name(s)

Behavior therapy

Intervention Description

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

Other

Intervention Name(s)

Psychoeducation

Intervention Description

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

Primary Outcome Measure Information:

Title

Aberrant Behavior Checklist - Community

Description

Severity of challenging behavior

Time Frame

Previous 2 weeks

Title

Parenting Stress Index

Description

Severity of parent stress

Time Frame

Previous 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Child is aged 3 to 5 years inclusive Child has a diagnosis of ASD (confirmed by diagnostic report) Child is reported to exhibit challenging behavior on a daily basis according to the BPI-S Child and participating parent/caregiver are English-speaking The child's primary caregiver is safely able to physically manage their child's challenging behavior during the FA and treatment The child's primary caregiver is available to implement the intervention over 12 weeks Exclusion Criteria: Child or caregiver has a neurological condition or sensory deficit that would preclude study participation Parent/caregiver is currently receiving direct parent coaching with a BCBA to manage their child's challenging behaviors Child is taking psychoactive medications for challenging behavior Child currently receives more than 5 hours per week of focused or comprehensive behavioral treatment Child engages in self-injury or aggression where exposure to the baseline conditions would place them or their caregiver at risk of serious or permanent harm

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Scott Hall, PhD

Phone

650-498-4799

hallss@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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