Autism Spectrum Disorder Clinical Trial
Official title:
Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
The purpose of this open label trial is to examine the preliminary 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 child-focused intervention.
Status | Not yet recruiting |
Enrollment | 44 |
Est. completion date | June 1, 2026 |
Est. primary completion date | June 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 17 Years |
Eligibility | Inclusion Criteria: - 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); - Scores in the top 50th percentile of the Insistence on Sameness total score on the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB); - High levels of emotion dysregulation as captured by a score in the clinical range on the Strengths and Difficulties Questionnaire; - 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; and - Family resides in U.S.A. Exclusion Criteria: - Parent or child diagnosed with severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or unstable medical problem (e.g., severe seizures); or - Child or parent have primary language other than English. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Stanford University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 (full measure), 3 weeks (IS subscale), 6 weeks (IS subscale), 9 weeks (IS subscale), 12 weeks (full measure) | |
Secondary | 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, 6 weeks, 12 weeks | |
Secondary | 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 | |
Secondary | Change from Baseline in Parent-Rated Irritability as captured by the Aberrant Behavior Checklist (ABC), Irritability Subscale. | The ABC-I includes 15 items with higher scores indicating greater irritability. [Score range: 0-45]. | Baseline, 6 weeks, 12 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Change from Baseline in Caregiver Self-Report on the Warwick-Edinburg Mental Wellbeing Scales (WEMWS). | Higher scores indicate lower mental wellbeing. [Score Range: 14-70] | Baseline, 12 weeks | |
Secondary | 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 | |
Secondary | Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ). | Higher scores indicate greater levels of core autism characteristics. [Score Range: 0-39] | Baseline, Week 12 | |
Secondary | 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 | |
Secondary | Daily Living Skills Scale (DLSS). | Higher scores indicate better ability on the DLSS. [Score Range: 0-53] | Baseline, Week 12 |
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