CompletedNot Applicable

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

United States75 participantsStarted 2019-05-13

Plain-language summary

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).

Who can participate

Age range

2 Years – 3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * Boys and girls between 2 years and 3 years and 11 months * Ability to participate in the testing procedures to the extent that valid standard scores can be obtained * 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 * Developmentally delayed with Mullen Scales of Early Learning (MSEL) or Developmental Profile (DP-4) composite score below 85 (1 Standard Deviation below the mean) * Availability of at least one English-speaking parent 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.) * Presence of active medical problem (e.g., unstable seizure disorder or heart disease) * Child primary language other than English * Previous adequate trial of Pivotal Response Treatment * More than 15 hours per week of in-home applied behavior analysis (ABA).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks

Timeframe: Baseline and Week 12

Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks

Timeframe: Baseline and Week 12

Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks

Timeframe: Baseline and Week 12

Trial details

NCT IDNCT03778827

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-28

View on ClinicalTrials.gov More Autism Spectrum Disorder trials

Who can participate

Age range

2 Years – 3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks

Timeframe: Baseline and Week 12

Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks

Timeframe: Baseline and Week 12

Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks

Timeframe: Baseline and Week 12