Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

NCT06362733 | Recruiting

• 1 other identifier: IRB-74165
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

Intervention; Pivotal Response Treatment

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB).

  DARB insistence on sameness subscale scores measure insistence on sameness with higher scores indicating greater intensity of insistence on sameness. \[Score Range: 0-76\]

  Screening, Baseline, every 2 weeks, 12 weeks, 24 weeks

Secondary Outcomes (12)

• Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings.

  Baseline, 12 weeks

• Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment.

  Baseline, 6 weeks, 12 weeks, 24 weeks

• Change from Baseline in Parent-Rated Behavioral Inflexibility as captured by the Behavioral Inflexibility Scale.

  Baseline, 6 weeks, 12 weeks, 24 weeks

• Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R).

  Baseline, 6 weeks, 12 weeks, 24 weeks

• Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS).

  Baseline, 12 weeks

Other Outcomes (1)

• Social Validity Measures

  Week 12

Study Arms (1)

Remote (Telehealth) Intervention Program

EXPERIMENTAL

Behavioral: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

Interventions

Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth BEHAVIORAL

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.

Remote (Telehealth) Intervention Program

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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 the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

401 Quarry Road (Remote Study)

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Antonio Hardan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Ferguson, PhD

CONTACT

650-736-1235; eferguso@stanford.edu

Robin Libove, BS

CONTACT

650-736-1235; rlibove@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 12, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)