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

NCT ID: NCT03778827

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder Autism

Keywords

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Pivotal Response Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

2 Years

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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John & Marcia Goldman Foundation

UNKNOWN

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Antonio Hardan

Professor of Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Y. Hardan, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anna Oft, BS

Role: CONTACT

Phone: (650)736-1235

Email: [email protected]

Madeleine Clark, BS

Role: CONTACT

Phone: (650)736-1235

Email: [email protected]

Facility Contacts

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Madeleine Clark, BS

Role: primary

Estefania Millan, MA

Role: backup

Other Identifiers

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IRB-49033

Identifier Type: -

Identifier Source: org_study_id