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

Trial ID or NCT#

NCT03778827

Status

recruiting iconRECRUITING

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).

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 2 Years to 3 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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).
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Investigator(s)

Antonio Hardan, M.D.
Antonio Hardan, M.D.
Psychiatrist
Professor of Psychiatry and Behavioral Sciences
Grace Gengoux

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Contact

Madeleine Clark, BS
650-736-1235

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View on ClinicalTrials.gov