Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Stanford University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB).
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Antonio Hardan
Professor of Psychiatry and Behavioral Sciences
Stanford University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
DARB insistence on sameness subscale scores measure insistence on sameness with higher scores indicating greater intensity of insistence on sameness. \[Score Range: 0-76\]
Secondary Outcomes
- 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 Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7).(Baseline, 12 weeks)
- Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS).(Baseline, 12 weeks)
- Change from Baseline in Family Accommodation Scale - RRB (FAS-RRB).(Baseline, 6 weeks, 12 weeks)
- Daily Living Skills Scale (DLSS).(Baseline, Week 12)
- Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD).(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21).(Baseline, 12 weeks)
- Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ).(Baseline, Week 12)
- Caregiver Report Executive Functioning Scale (EFS).(Baseline, Week 12)