Recruiting

Behavioral Intervention

Sponsor:

Stanford University

Code:

NCT06362733

Conditions

Autism Spectrum Disorder

Restricted Behavior

Autism

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Accepted

Interventions

Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

Study Details

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.

Conditions

Autism Spectrum Disorder

Restricted Behavior

Autism

Study ID

NCT06362733

Start date

Jul 11, 2024

Status verified date

Jun, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

44 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Remote (Telehealth) Intervention Program

Interventions

Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

This is a 12-week intervention program (1 hour/week) of treatment to target insistence on sameness in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of combination of parent-training and parent-mediated intervention with the child.

Primary outcome measure

  • Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB). [ Time Frame: Screening, Baseline, every 2 weeks, 12 weeks, 24 weeks ]

Central Contacts and Locations

Central contacts

Emily Ferguson, PhD

650-736-1235eferguso@stanford.edu

Robin Libove, BS

650-736-1235rlibove@stanford.edu

Locations

401 Quarry Road (Remote Study)

Recruiting

Stanford, California, United States, 94305

Contacts

Emily F Ferguson, PhD

650-736-1235eferguso@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Intervention
  • Pivotal Response Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2026-06-25.