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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 3
Healthy Volunteers: f
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• 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.

Locations
United States
California
Stanford University School of Medicine
RECRUITING
Stanford
Contact Information
Primary
Anna Oft, BS
aoft@stanford.edu
(650)736-1235
Backup
Madeleine Clark, BS
mclark11@stanford.edu
(650)736-1235
Time Frame
Start Date: 2019-05-13
Estimated Completion Date: 2025-12
Participants
Target number of participants: 44
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: John & Marcia Goldman Foundation
Leads: Stanford University

This content was sourced from clinicaltrials.gov

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