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).

Investigator(s)

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

Contact us to find out if this trial is right for you.

Contact

Madeleine Clark, BS
650-736-1235