Behavioral intervention for rigidity in autistic youth
Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
This study is trying out a 12-week program that helps parents support their autistic kids, aged 4 to 17, in being more flexible and open to change.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT06362733 on ClinicalTrials.gov |
What this trial studies
This open-label trial aims to evaluate the feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program designed to address insistence on sameness in youth with autism spectrum disorder (ASD). The intervention involves a combination of parent-training and parent-mediated strategies delivered through a secure telemedicine platform, with sessions occurring once a week for one hour. Participants will include children aged 4 to 17 years diagnosed with ASD and experiencing significant behavioral inflexibility. The study seeks to provide insights into the effectiveness of this modified approach to pivotal response treatment.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 17 years with a diagnosis of autism spectrum disorder and significant concerns regarding insistence on sameness.
Not a fit: Patients who do not exhibit significant behavioral inflexibility or insistence on sameness may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the flexibility and adaptability of autistic youth, enhancing their daily functioning and quality of life.
How similar studies have performed: While this approach is based on established behavioral interventions, the specific application of modified pivotal response treatment for insistence on sameness is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Stanford, California
- 401 Quarry Road (Remote Study) — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Antonio Hardan, MD — Stanford University
- Study coordinator: Emily Ferguson, PhD
- Email: eferguso@stanford.edu
- Phone: 650-736-1235
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.