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

Primary Purpose

Autism Spectrum Disorder, Autism

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intensive Center-Based Pivotal Response Treatment (PRT-C)

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Pivotal Response Treatment

Eligibility Criteria

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

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).

Sites / Locations

Stanford University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intensive Center-Based Pivotal Response Treatment (PRT-C)

Delayed Treatment Group (DTG)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks

Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks

Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks

Secondary Outcome Measures

Mean change from baseline on the Vineland Adaptive Behavior Scales 3rd Edition Socialization subscale at 12 Weeks

Mean change from baseline on the MacArthur-Bates Communication Development Inventory at 12 Weeks

Full Information

NCT ID

NCT03778827

First Posted

December 15, 2018

Last Updated

March 2, 2023

Sponsor

Stanford University

Collaborators

John & Marcia Goldman Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03778827

Brief Title

A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism

Acronym

PRT-C

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 8, 2019 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

John & Marcia Goldman Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

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

Autism Spectrum Disorder, Autism

Keywords

Pivotal Response Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intensive Center-Based Pivotal Response Treatment (PRT-C)

Arm Type

Experimental

Arm Description

Arm Title

Delayed Treatment Group (DTG)

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Intensive Center-Based Pivotal Response Treatment (PRT-C)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks

Time Frame

Baseline and Week 12

Title

Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks

Time Frame

Baseline and Week 12

Title

Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

Mean change from baseline on the Vineland Adaptive Behavior Scales 3rd Edition Socialization subscale at 12 Weeks

Time Frame

Baseline and Week 12

Title

Mean change from baseline on the MacArthur-Bates Communication Development Inventory at 12 Weeks

Time Frame

Baseline and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

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

Madeleine Clark, BS

Phone

(650)736-1235

mclark11@stanford.edu

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

Estefania Millan, MA

Phone

(650)736-1235

mmillan2@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonio Y. Hardan, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Madeleine Clark, BS

Phone

650-736-1235

mclark11@stanford.edu

First Name & Middle Initial & Last Name & Degree

Estefania Millan, MA

Phone

(650)736-1235

mmillan2@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD

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A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism

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