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Recruiting
NCT06362733
Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
Conditions: Autism Spectrum Disorder, Restricted Behavior, Autism
Sex: All
Ages: 4 Years – 17 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 44
Sponsor: Stanford University
Location: 401 Quarry Road (Remote Study) Stanford California
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.
Source: ClinicalTrials.gov (NCT06362733). StuddyBuddy aggregates publicly available trial information.