NCT04899544 Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
| NCT ID | NCT04899544 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Autism |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-10-18 |
| Primary Completion | 2028-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-10-18 with a primary completion date of 2028-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Antonio Y. Hardan, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT04899544 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 5 Years, studying Autism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04899544 currently recruiting?
Yes, NCT04899544 is actively recruiting participants. Contact the research team at PALprogram@stanford.edu for enrollment information.
Where is the NCT04899544 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT04899544 clinical trial?
NCT04899544 is sponsored by Stanford University. The principal investigator is Antonio Y. Hardan, MD at Stanford University. The trial plans to enroll 120 participants.