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

Study Overview
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Behavior therapy
* Other: Psychoeducation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-person treatment<br> | Behavioral: Behavior therapy<br>* 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.<br>|
| Active Comparator: Telehealth-enabled treatment<br> | Behavioral: Behavior therapy<br>* 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.<br>|
| Placebo Comparator: Psychoeducation<br> | Other: Psychoeducation<br>* Caregivers will complete online education modules in 1-hour sessions each week over 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aberrant Behavior Checklist - Community | Severity of challenging behavior | Previous 2 weeks | 
| Parenting Stress Index | Severity of parent stress | Previous 4 weeks |