Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
- Conditions
- Autism Spectrum DisorderRestricted BehaviorAutism
- Interventions
- Behavioral: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
- Registration Number
- NCT06362733
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 44
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Remote (Telehealth) Intervention Program Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth -
- Primary Outcome Measures
Name Time Method Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB). 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 Outcome Measures
Name Time Method Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings. Baseline, 12 weeks 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.
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 SDQ-DP indexes broad emotion dysregulation with higher scores indicating greater intensity of emotion dysregulation. \[Score Range: 1-27\]
Change from Baseline in Parent-Rated Behavioral Inflexibility as captured by the Behavioral Inflexibility Scale. Baseline, 6 weeks, 12 weeks, 24 weeks The BIS includes 38 items with higher scores indicating greater irritability. \[Score range: 0-190\].
Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R). Baseline, 6 weeks, 12 weeks, 24 weeks Higher scores indicate higher levels of RRBs. \[43 items, 12 in sameness domain\]
Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7). Baseline, 12 weeks 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. \[Score Range: 2-10\]
Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS). Baseline, 12 weeks 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. \[18 items\]
Change from Baseline in Family Accommodation Scale - RRB (FAS-RRB). Baseline, 6 weeks, 12 weeks Higher scores indicate higher levels of parental accommodation of insistence on sameness behaviors \[11 items on a 5-point scale to assess frequency of accommodation behaviors\].
Daily Living Skills Scale (DLSS). Baseline, Week 12 Higher scores indicate better ability on the DLSS. \[Score Range: 0-53\]
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 ASC-ASD captures anxiety with higher scores indicating greater anxiety severity across the subdomains of separation anxiety, uncertainty, performance anxiety, and anxious arousal. \[Score Range: 0-72\]
Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21). Baseline, 12 weeks Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. \[Scores \> 34 fall in "extremely severe range'\]
Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ). Baseline, Week 12 Higher scores indicate greater levels of core autism characteristics. \[Score Range: 0-39\]
Caregiver Report Executive Functioning Scale (EFS). Baseline, Week 12 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. \[Score Range: 0-52\]
Trial Locations
- Locations (1)
401 Quarry Road (Remote Study)
🇺🇸Stanford, California, United States