NCT06362733 Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
| NCT ID | NCT06362733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-07-11 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 44 participants in total. It began in 2024-07-11 with a primary completion date of 2026-07-01.
⚠ 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 purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.
Eligibility Criteria
Participants will include children with: 1. parent/guardian aged 18 years or older with a child aged between 4.0 to 17.11 years old at the time of parental consent; 2. diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., ADOS) or suspicion of ASD diagnosis and confirmed with Autism Diagnostic Interview-Revised (ADI-R); 3. parent-reported clinically significant concerns regarding insistence on sameness and behavioral inflexibility; 4. stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes; 5. English-speaking parent and youth able to consistently participate in study procedures; 6. family resides in United States.
Contact & Investigator
Antonio Hardan, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT06362733 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 17 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06362733 currently recruiting?
Yes, NCT06362733 is actively recruiting participants. Contact the research team at eferguso@stanford.edu for enrollment information.
Where is the NCT06362733 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT06362733 clinical trial?
NCT06362733 is sponsored by Stanford University. The principal investigator is Antonio Hardan, MD at Stanford University. The trial plans to enroll 44 participants.