protocolSection identificationModule nctId: NCT06362733, orgStudyIdInfo id: IRB-74165, briefTitle: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Autism Spectrum Disorder, conditions: Restricted Behavior, conditions: Autism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth, outcomesModule primaryOutcomes measure: Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB)., secondaryOutcomes measure: Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings., secondaryOutcomes measure: Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment., secondaryOutcomes measure: Change from Baseline in Parent-Rated Irritability as captured by the Aberrant Behavior Checklist (ABC), Irritability Subscale., secondaryOutcomes measure: Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R)., secondaryOutcomes measure: Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS)., secondaryOutcomes measure: Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD)., secondaryOutcomes measure: Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7)., secondaryOutcomes measure: Change from Baseline in Caregiver Self-Report on the Warwick-Edinburg Mental Wellbeing Scales (WEMWS)., secondaryOutcomes measure: Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21)., secondaryOutcomes measure: Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ)., secondaryOutcomes measure: Caregiver Report Executive Functioning Scale (EFS)., secondaryOutcomes measure: Daily Living Skills Scale (DLSS)., eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False