Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT06362733
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2024-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Social Validity Measures', 'timeFrame': 'Week 12', 'description': 'Caregivers will complete a survey and interview post-intervention to assess feasibility, acceptability, and satisfaction with the intervention.'}], 'primaryOutcomes': [{'measure': 'Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB).', 'timeFrame': 'Screening, Baseline, every 2 weeks, 12 weeks, 24 weeks', 'description': 'DARB insistence on sameness subscale scores measure insistence on sameness with higher scores indicating greater intensity of insistence on sameness. \\[Score Range: 0-76\\]'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings.', 'timeFrame': 'Baseline, 12 weeks', 'description': '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.'}, {'measure': 'Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment.', 'timeFrame': 'Baseline, 6 weeks, 12 weeks, 24 weeks', 'description': 'SDQ-DP indexes broad emotion dysregulation with higher scores indicating greater intensity of emotion dysregulation. \\[Score Range: 1-27\\]'}, {'measure': 'Change from Baseline in Parent-Rated Behavioral Inflexibility as captured by the Behavioral Inflexibility Scale.', 'timeFrame': 'Baseline, 6 weeks, 12 weeks, 24 weeks', 'description': 'The BIS includes 38 items with higher scores indicating greater irritability. \\[Score range: 0-190\\].'}, {'measure': 'Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R).', 'timeFrame': 'Baseline, 6 weeks, 12 weeks, 24 weeks', 'description': 'Higher scores indicate higher levels of RRBs. \\[43 items, 12 in sameness domain\\]'}, {'measure': 'Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS).', 'timeFrame': 'Baseline, 12 weeks', 'description': '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\\]'}, {'measure': 'Change from Baseline in Family Accommodation Scale - RRB (FAS-RRB).', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': '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\\].'}, {'measure': 'Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD).', 'timeFrame': 'Baseline, 6 weeks, 12 weeks, 24 weeks', 'description': '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\\]'}, {'measure': 'Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7).', 'timeFrame': 'Baseline, 12 weeks', 'description': '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\\]'}, {'measure': 'Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21).', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. \\[Scores \\> 34 fall in "extremely severe range\'\\]'}, {'measure': 'Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ).', 'timeFrame': 'Baseline, Week 12', 'description': 'Higher scores indicate greater levels of core autism characteristics. \\[Score Range: 0-39\\]'}, {'measure': 'Caregiver Report Executive Functioning Scale (EFS).', 'timeFrame': 'Baseline, Week 12', 'description': '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\\]'}, {'measure': 'Daily Living Skills Scale (DLSS).', 'timeFrame': 'Baseline, Week 12', 'description': 'Higher scores indicate better ability on the DLSS. \\[Score Range: 0-53\\]'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intervention', 'Pivotal Response Treatment'], 'conditions': ['Autism Spectrum Disorder', 'Restricted Behavior', 'Autism']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Participants will include children with:\n\n1. 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;\n2. 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);\n3. parent-reported clinically significant concerns regarding insistence on sameness and behavioral inflexibility;\n4. stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes;\n5. English-speaking parent and youth able to consistently participate in study procedures;\n6. family resides in United States.'}, 'identificationModule': {'nctId': 'NCT06362733', 'acronym': 'M-PRT-IS', 'briefTitle': 'Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth', 'orgStudyIdInfo': {'id': 'IRB-74165'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote (Telehealth) Intervention Program', 'interventionNames': ['Behavioral: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth']}], 'interventions': [{'name': 'Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Remote (Telehealth) Intervention Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily F Ferguson, PhD', 'role': 'CONTACT', 'email': 'eferguso@stanford.edu', 'phone': '650-736-1235'}], 'facility': '401 Quarry Road (Remote Study)', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Emily Ferguson, PhD', 'role': 'CONTACT', 'email': 'eferguso@stanford.edu', 'phone': '650-736-1235'}, {'name': 'Robin Libove, BS', 'role': 'CONTACT', 'email': 'rlibove@stanford.edu', 'phone': '650-736-1235'}], 'overallOfficials': [{'name': 'Antonio Hardan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry and Behavioral Sciences', 'investigatorFullName': 'Antonio Hardan', 'investigatorAffiliation': 'Stanford University'}}}}