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

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ClinicalTrials.gov Identifier: NCT03778827
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio Hardan, Stanford University

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).

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Autism Behavioral: Intensive Center-Based Pivotal Response Treatment (PRT-C) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Center Based Randomized Controlled Trial of Pivotal Response Treatment for Preschoolers With Autism
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks [ Time Frame: Baseline and Week 12 ]
  2. Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks [ Time Frame: Baseline and Week 12 ]
  3. 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 Measures :
  1. Mean change from baseline on the Vineland Adaptive Behavior Scales 3rd Edition Socialization subscale at 12 Weeks [ Time Frame: Baseline and Week 12 ]
  2. Mean change from baseline on the MacArthur-Bates Communication Development Inventory at 12 Weeks [ Time Frame: Baseline and Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of autism spectrum disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, 2nd edition (ADOS-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 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778827


Contacts
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Contact: Jane Shkel, MS, BCBA (650)736-1235 jshkel@stanford.edu
Contact: Estefania Millan, MA (650)736-1235 mmillan2@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Jane Shkel, MS, BCBA    650-736-1235    jshkel@stanford.edu   
Contact: Estefania Millan, MA    (650)736-1235    mmillan2@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Antonio Y. Hardan, MD Stanford University

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Responsible Party: Antonio Hardan, Professor of Psychiatry and Behavioral Sciences, Stanford University
ClinicalTrials.gov Identifier: NCT03778827     History of Changes
Other Study ID Numbers: IRB-49033
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antonio Hardan, Stanford University:
Pivotal Response Treatment

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders