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

Not Applicable

Recruiting

• Conditions: Autism; ASD; Autism Spectrum Disorder
• Interventions: Behavioral: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C); Behavioral: Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)

• Registration Number: NCT04899544
• Lead Sponsor: Stanford University

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-24
• Study Start: 2022-10-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2026-09-15
• Study Completion: 2026-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 or primary caregiver who can consistently participate in parent training and research measures.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)	Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)	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.
Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H)	Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)	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.

Primary Outcome Measures

Name	Time	Method
Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).	Baseline,16 Weeks.

Secondary Outcome Measures

Name	Time	Method
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 Stanford Social Dimension Scale (SSDS) Scores	Baseline,16 Weeks.	Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290).
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Scores	Baseline,16 Weeks.	Social Responsiveness Scale, 2nd Edition (SRS-2) scores measure social abilities with lower scores meaning better social abilities.
Change on the Clinical Global Impressions (CGI) Scale.	Baseline,16 Weeks.
Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment.	Baseline,16 Weeks.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States