RECRUITING

Trial of Center-Based Vs. In-Home Pivotal Response Treatment (PRT) in Autism

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Conditions

AutismAutism Spectrum DisorderASDpivotal response treatmentPRTcenter basedsocial and communication

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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 aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).

Official Title

Randomized Controlled Trial of Center-Based Vs. In-Home Pivotal Response Treatment (PRT) in Autism

Quick Facts

Study Start:2022-10-18
Study Completion:2026-09-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04899544

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 5 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 Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (DSM-5), and expert clinical opinion;
  2. * Boys and girls between 2.0 and 5.11 years;
  3. * Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;
  4. * Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds;
  5. * Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements;
  6. * No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H);
  7. * No more than 60 minutes of individual 1:1 speech therapy per week;
  8. * Availability of at least one parent or primary caregiver 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. * Receiving ABA of 15 hours or more;
  3. * Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
  4. * Previous adequate Pivotal Response Treatment (PRT) trial;
  5. * Participants living more than 30 miles from Stanford University;
  6. * Child's primary language other than English.

Contacts and Locations

Study Contact

Maddy Clark
CONTACT
(650)736-1235
mclark11@stanford.edu
Robin Libove
CONTACT
(650)736-1235
rlibove@stanford.edu

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 Date2022-10-18
Study Completion Date2026-09-15

Study Record Updates

Study Start Date2022-10-18
Study Completion Date2026-09-15

Terms related to this study

Keywords Provided by Researchers

  • pivotal response treatment
  • PRT
  • center based
  • social and communication

Additional Relevant MeSH Terms

  • Autism
  • Autism Spectrum Disorder
  • ASD