NCT03778827

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

May 13, 2019

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2026

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

6.9 years

First QC Date

December 15, 2018

Last Update Submit

April 2, 2026

Conditions

AutismAutism Spectrum Disorder

Keywords

Pivotal Response Treatment

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

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

EXPERIMENTAL

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)

Delayed Treatment Group (DTG)

NO INTERVENTION

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.

Interventions

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

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

Eligibility Criteria

Age2 Years - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Antonio Y. Hardan, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

December 15, 2018

First Posted

December 19, 2018

Study Start

May 13, 2019

Primary Completion

March 28, 2026

Study Completion

March 28, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)