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Comparing Center-Based vs. Home-Based Pivotal Response Treatment for Autism

This study is looking at two ways to deliver Pivotal Response Treatment (PRT) for young children with autism spectrum disorder (ASD) and language delays. Researchers want to see if PRT given in a center (PRT-C) is more effective than PRT given at home (PRT-H) for improving social communication. They will compare these two groups to a control group receiving their usual care. You might be able to join if you have a child aged 2 to 5 years old with an ASD diagnosis and significant language delay. The main goal is to measure changes in the number of words your child uses during parent-child interactions over 16 weeks. The current status of this study is unclear.

Study design
This interventional study plans to enroll 120 participants. It compares two types of behavioral therapy (PRT-C and PRT-H) to a control group receiving usual treatment.
What's involved
Participants will receive 16 weeks of either center-based or home-based Pivotal Response Treatment. Child utterances will be measured at the beginning and after 16 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 16 weeks, indicating follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04899544

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

Recruiting
NAAges 2–5InterventionalTreatment
Stanford University
~120 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).
Measured over Baseline,16 Weeks.

Conditions

Autism
Autism Spectrum Disorder
ASD

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Autism Spectrum Disorder

NCT04899544

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Stanford University School of Medicine

    Stanford, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Maddy Clark
[email protected]
(650)736-1235
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).Baseline,16 Weeks.