Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism

Study Overview
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Brief Summary
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The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).

Official Title
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Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism

Conditions
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ASD, Autism, Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
* Behavioral: Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (DSM-5), and expert clinical opinion; Boys and girls between 2.0 and 5.11 years; Ability to participate in the testing procedures to the extent that valid standard scores can be obtained; Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds; Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements; No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H); No more than 60 minutes of individual 1:1 speech therapy per week; Availability of at least one parent who can consistently participate in parent training and research measures. Exclusion Criteria: Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.); Receiving ABA of 15 hours or more; Presence of active medical problem (e.g., unstable seizure disorder or heart disease); Previous adequate Pivotal Response Treatment (PRT) trial; Participants living more than 30 miles from Stanford University; Child's primary language other than English.

Ages Eligible for Study
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Minimum Age: 2 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 |
| --- | --- |
| Experimental: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)<br>A 16-week center-based PRT intervention (PRT-C) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits. | Behavioral: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)<br>* Pivotal Response Treatment in autism center.<br>|
| Experimental: Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H)<br>A 16-week home-based PRT intervention (PRT-H) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits. | Behavioral: Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)<br>* Pivotal Response Treatment in home environment.<br>|
| No Intervention: Treatment As Usual (TAU)<br>This is a control group that consists of children who are receiving treatment as usual (TAU) for a 16-week period. These families will be invited to participate in PRT after completing the 16-week TAU phase. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO). |  | Baseline,16 Weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on MacArthur-Bates Communication Development Inventory (CDI) Scores |  | Baseline,16 Weeks. | 
| Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores |  | Baseline,16 Weeks. | 
| Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Score | Social Responsiveness Scale, 2nd Edition (SRS-2) scores measure social abilities with lower scores meaning better social abilities. | Baseline,16 Weeks. | 
| Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores | Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290). | Baseline,16 Weeks. | 
| Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment. |  | Baseline,16 Weeks. | 
| Change on the Clinical Global Impressions (CGI) Scale. |  | Baseline,16 Weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRT, pivotal response treatment, center based, social and communication