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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-5
SponsorStanford University

About this trial

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).

Eligibility criteria

Qualifiers

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;

Boys and girls between 2.0 and 5.11 years;

Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;

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;

Disqualifiers

Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);

Receiving ABA of 15 hours or more;

Presence of active medical problem (e.g., unstable seizure disorder or heart disease);

Previous adequate Pivotal Response Treatment (PRT) trial;

Trial design

Treatments tested in this trial

  • Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
  • Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Stanford University

Lead sponsor

Anonymous Donor

Collaborator