Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth (M-PRT-IS)

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Autism; Restricted Behavior
• Intervention / Treatment: Behavioral: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Ferguson, PhD; Phone Number: 650-736-1235; Email: eferguso@stanford.edu
• Study Contact Backup: Name: Robin Libove, BS; Phone Number: 650-736-1235; Email: rlibove@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • 401 Quarry Road (Remote Study)
      • Contact: Emily F Ferguson, PhD; Phone Number: 650-736-1235; Email: eferguso@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote (Telehealth) Intervention Program	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS).	The OS-CBS captures the severity of categories of challenging behaviors, including property destruction, aggression, elopement, conduct problems, and self-injurious behaviors, with the option to calculate a total score for each subscale and total challenging behavior, with higher score averages indicating higher severity. [18 items]	Baseline, 12 weeks
Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7).	The CGSQ-SF7 assesses additional demands, pressures, and responsibilities in families with youths suffering from behavioral or emotional disorders, with higher scores indicating greater strain. [Score Range: 2-10]	Baseline, 12 weeks
Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21).	Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. [Scores > 34 fall in "extremely severe range']	Baseline, 12 weeks
Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ).	Higher scores indicate greater levels of core autism characteristics. [Score Range: 0-39]	Baseline, Week 12
Caregiver Report Executive Functioning Scale (EFS).	The EFS characterizes sequencing/working memory, response inhibition, set shifting, emotion regulation, and risk-taking facets of executive functioning. Higher scores indicate better executive functioning. [Score Range: 0-52]	Baseline, Week 12
Daily Living Skills Scale (DLSS).	Higher scores indicate better ability on the DLSS. [Score Range: 0-53]	Baseline, Week 12
Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings.	Score Range: 1 = normal, not at all ill; 7 = among the most extremely ill patients; 1 = very much informed since the initiation of treatment; 7 = very much worse since the initiation of treatment.	Baseline, 12 weeks
Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment.	SDQ-DP indexes broad emotion dysregulation with higher scores indicating greater intensity of emotion dysregulation. [Score Range: 1-27]	Baseline, 6 weeks, 12 weeks, 24 weeks
Change from Baseline in Parent-Rated Behavioral Inflexibility as captured by the Behavioral Inflexibility Scale.	The BIS includes 38 items with higher scores indicating greater irritability. [Score range: 0-190].	Baseline, 6 weeks, 12 weeks, 24 weeks
Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R).	Higher scores indicate higher levels of RRBs. [43 items, 12 in sameness domain]	Baseline, 6 weeks, 12 weeks, 24 weeks
Change from Baseline in Family Accommodation Scale - RRB (FAS-RRB).	Higher scores indicate higher levels of parental accommodation of insistence on sameness behaviors [11 items on a 5-point scale to assess frequency of accommodation behaviors].	Baseline, 6 weeks, 12 weeks
Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD).	ASC-ASD captures anxiety with higher scores indicating greater anxiety severity across the subdomains of separation anxiety, uncertainty, performance anxiety, and anxious arousal. [Score Range: 0-72]	Baseline, 6 weeks, 12 weeks, 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Validity Measures	Caregivers will complete a survey and interview post-intervention to assess feasibility, acceptability, and satisfaction with the intervention.	Week 12

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Antonio Hardan, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Intervention; Pivotal Response Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: IRB-74165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No