Stanford, California 94305


Purpose:

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 summary:

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.


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).


NCT ID:

NCT03778827


Primary Contact:

Principal Investigator
Antonio Y. Hardan, MD
Stanford University

Jane Shkel, MS, BCBA
Phone: (650)736-1235
Email: jshkel@stanford.edu


Backup Contact:

Email: mmillan2@stanford.edu
Estefania Millan, MA
Phone: (650)736-1235


Location Contact:

Stanford, California 94305
United States

Jane Shkel, MS, BCBA
Phone: 650-736-1235
Email: jshkel@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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