ACTIVE_NOT_RECRUITING

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

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Conditions

Autism Spectrum DisorderAutismPivotal Response Treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2019-05-13
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03778827

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 3 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion 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
  2. * Boys and girls between 2 years and 3 years and 11 months
  3. * Ability to participate in the testing procedures to the extent that valid standard scores can be obtained
  4. * 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
  5. * Developmentally delayed with Mullen Scales of Early Learning (MSEL) or Developmental Profile (DP-4) composite score below 85 (1 Standard Deviation below the mean)
  6. * Availability of at least one English-speaking parent who can consistently participate in parent training and research measures.
  1. * Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.)
  2. * Presence of active medical problem (e.g., unstable seizure disorder or heart disease)
  3. * Child primary language other than English
  4. * Previous adequate trial of Pivotal Response Treatment
  5. * More than 15 hours per week of in-home applied behavior analysis (ABA).

Contacts and Locations

Principal Investigator

Antonio Y. Hardan, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University School of Medicine
Stanford, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Antonio Y. Hardan, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-13
Study Completion Date2026-06

Study Record Updates

Study Start Date2019-05-13
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Pivotal Response Treatment

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Autism