A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism (PRT-C)

A Center Based Randomized Controlled Trial of Pivotal Response Treatment for Preschoolers With Autism

The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (ASD).

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Behavioral: Intensive Center-Based Pivotal Response Treatment (PRT-C)

Detailed Description

The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based preschool environment to treat social communication deficits in children with autism spectrum disorder (ASD). The study will compare Pivotal Response Treatment (PRT) to a delayed treatment group (DTG). PRT is a naturalistic behavioral intervention based on the principles of applied behavior analysis which has shown to be effective in treating the core deficits in children with ASD. The study will compare the combination of parent training with intensive center-based PRT (PRT-C) to a DTG and will include 44 children ages 2 to 3.11 years with ASD and social communication deficits.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madeleine Clark, BS; Phone Number: (650)736-1235; Email: mclark11@stanford.edu
• Study Contact Backup: Name: Estefania Millan, MA; Phone Number: (650)736-1235; Email: mmillan2@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University School of Medicine
      • Contact: Estefania Millan, MA; Phone Number: (650)736-1235; Email: mmillan2@stanford.edu
      • Contact: Madeleine Clark, BS; Phone Number: 650-736-1235; Email: mclark11@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Autism Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) or Childhood Autism Rating Scale (CARS-2); Diagnostic and Statistical Manual, 5th edition (DSM-5), and expert clinical opinion
• Boys and girls between 2 years and 3 years and 11 months
• Ability to participate in the testing procedures to the extent that valid standard scores can be obtained
• Stable treatment (e.g., applied behavior analysis (ABA), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
• Developmentally delayed with Mullen Scales of Early Learning (MSEL) or Developmental Profile (DP-4) composite score below 85 (1 Standard Deviation below the mean)
• Availability of at least one English-speaking 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.)
• Presence of active medical problem (e.g., unstable seizure disorder or heart disease)
• Child primary language other than English
• Previous adequate trial of Pivotal Response Treatment
• More than 15 hours per week of in-home applied behavior analysis (ABA).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Center-Based Pivotal Response Treatment (PRT-C); Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of one weekly 60-minute individual parent training session and 12 weekly hours ( 3 hours per day for 4 days per week) with the child in center-based therapy environment for a total of 13 weekly treatment hours.	Behavioral: Intensive Center-Based Pivotal Response Treatment (PRT-C); Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of weekly individual parent training sessions and center-based therapy for a total of 13 weekly treatment hours.
No Intervention: Delayed Treatment Group (DTG); Delayed Treatment Group will consist of treatment as usual. At the end of controlled phase, participants in the DTG will be offered PRT-C in a preschool setting in an open-label fashion with a design similar to the double-blind phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks	Baseline and Week 12
Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks	Baseline and Week 12
Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline on the Vineland Adaptive Behavior Scales 3rd Edition Socialization subscale at 12 Weeks	Baseline and Week 12
Mean change from baseline on the MacArthur-Bates Communication Development Inventory at 12 Weeks	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: John & Marcia Goldman Foundation
• Investigators: Principal Investigator: Antonio Y. Hardan, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 15, 2018
• First Submitted That Met QC Criteria: December 15, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pivotal Response Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: IRB-49033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No