Comparing center-based and home-based treatment for young children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of two different approaches to Pivotal Response Treatment (PRT) for young children with autism spectrum disorder (ASD) who have significant language delays. Participants will be divided into two groups: one receiving center-based PRT and the other receiving home-based PRT, with a control group receiving treatment as usual. The study will last for 16 weeks and will assess improvements in social communication skills. The trial will utilize standardized assessments to measure language abilities and social communication outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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;
* 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;
* No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H);
* No more than 60 minutes of individual 1:1 speech therapy per week;
* Availability of at least one parent or primary caregiver who can consistently participate in parent training and research measures.

Exclusion Criteria:

* 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;
* Participants living more than 30 miles from Stanford University;
* Child's primary language other than English.

Where it's running

• Stanford University School of Medicine
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Antonio Y. Hardan, MD — Stanford University
• Study coordinator: Beatrice Begley
• Email: PALprogram@stanford.edu
• Phone: (650)736-1235

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.