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Recruiting NCT06362733

Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth

No phase Interventional Autism Spectrum Disorder Restricted Behavior Autism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder, Restricted Behavior, Autism. Basic parameters: 4 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings. [Time frame: Baseline, 12 weeks]
  • Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment. [Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks]
  • Change from Baseline in Parent-Rated Behavioral Inflexibility as captured by the Behavioral Inflexibility Scale. [Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks]
  • Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R). [Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks]
  • Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS). [Time frame: Baseline, 12 weeks]
  • Change from Baseline in Family Accommodation Scale - RRB (FAS-RRB). [Time frame: 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). [Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks]
  • Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7). [Time frame: Baseline, 12 weeks]
  • Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21). [Time frame: Baseline, 12 weeks]
  • Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ). [Time frame: Baseline, Week 12]
  • Caregiver Report Executive Functioning Scale (EFS). [Time frame: Baseline, Week 12]
  • Daily Living Skills Scale (DLSS). [Time frame: Baseline, Week 12]

Eligibility criteria

Participants will include children with:

  • 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;
  • 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);
  • parent-reported clinically significant concerns regarding insistence on sameness and behavioral inflexibility;
  • stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes;
  • English-speaking parent and youth able to consistently participate in study procedures;
  • family resides in United States.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • 401 Quarry Road (Remote Study) — Stanford

Identifiers

NCT: NCT06362733 · IRB-74165

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗