Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-26 @ 5:35 AM
Study NCT ID:
NCT02276534
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2014-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SENSE Theatre Intervention for Children With Autism Spectrum Disorder (ASD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-12', 'studyFirstSubmitDate': '2014-10-15', 'studyFirstSubmitQcDate': '2014-10-27', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NEPSY Memory for faces', 'timeFrame': 'Change from Baseline at Week 10 and Week 16', 'description': 'The measure requires the child to observe 16 faces of children and then remember them immediately and following a 30-minute delay. Raw scores are generated which are converted to standardized scores based on normative data.'}, {'measure': 'Measurement of Salivary Cortisol levels', 'timeFrame': 'Change from Baseline Cortisol level at 20 minutes, 40 minutes, 60 minutes'}, {'measure': 'Event Related Potentials (ERP) incidental memory task', 'timeFrame': 'Change from baseline at Week 10 and Week 16'}, {'measure': 'Social Responsiveness Scale', 'timeFrame': 'Change from baseline at Week 10 and Week 16'}, {'measure': 'Peer Interaction Playground Paradigm', 'timeFrame': 'Change from baseline at Week 10 and Week 16', 'description': 'A playground play session conducted with trained typically developing peers.'}, {'measure': 'Adaptive Behavior Assessment System', 'timeFrame': 'Change from baseline at Week 10 and Week 16', 'description': "Parent questionnaire of child's adaptive behavior"}, {'measure': 'Parenting Stress Index', 'timeFrame': 'Change from baseline at Week 10 and Week 16', 'description': 'parent-based questionnaire'}], 'secondaryOutcomes': [{'measure': 'Clinical Evaluation of Fundamentals Recalling Sentences subtest', 'timeFrame': 'Change from baseline at Week 10 and Week 16'}, {'measure': 'Peabody Picture Vocabulary Test', 'timeFrame': 'Change from baseline at Week 10 and Week 16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '31679960', 'type': 'DERIVED', 'citation': 'Key AP, Corbett BA. The Unfulfilled Promise of the N170 as a Social Biomarker. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Mar;5(3):342-353. doi: 10.1016/j.bpsc.2019.08.011. Epub 2019 Sep 13.'}, {'pmid': '31589087', 'type': 'DERIVED', 'citation': 'Corbett BA, Ioannou S, Key AP, Coke C, Muscatello R, Vandekar S, Muse I. Treatment Effects in Social Cognition and Behavior following a Theater-based Intervention for Youth with Autism. Dev Neuropsychol. 2019 Oct;44(7):481-494. doi: 10.1080/87565641.2019.1676244. Epub 2019 Oct 7.'}]}, 'descriptionModule': {'briefSummary': "The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.", 'detailedDescription': "The investigator's goal is to address the need for the development of social interventions for youth with autism in an innovative intervention, SENSE Theatre. The intervention blends established behavioral strategies with theatre techniques that emphasize the involvement of peers, play and performance. The resulting synergy extends promising pilot studies in a randomized group experiment.\n\nObjectives: The purpose of the study is to evaluate and extend the impact of a peer-mediated, theatre-based intervention on children with ASD with an emphasis on social functioning. The 10-session program incorporates theatrical approaches, trained typically developing peers and established behavioral strategies. Previous studies using pre-post designs have reported improvement in several skills, such as face memory, theory of mind and social cognition. A primary objective of this investigation is to utilize a true experimental design while evaluating social ability across multiple levels of analysis including neuropsychological, cognitive, behavioral, and functional outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children diagnosed with autism spectrum disorder with IQ ≥ to 70.\n\nExclusion Criteria:\n\n* IQ ≤ 70, children with current aggression toward self or others.'}, 'identificationModule': {'nctId': 'NCT02276534', 'briefTitle': 'SENSE Theatre Intervention for Children With Autism Spectrum Disorder (ASD)', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'SENSE Theatre Research Program', 'orgStudyIdInfo': {'id': '110082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Theatre', 'description': 'The participants will receive 10 sessions of peer-mediated, theatre-based intervention.', 'interventionNames': ['Behavioral: SENSE Theatre']}, {'type': 'EXPERIMENTAL', 'label': 'No Intervention then Theatre', 'description': 'The participants will not receive the treatment for a period of time.', 'interventionNames': ['Behavioral: Delayed Intervention']}], 'interventions': [{'name': 'SENSE Theatre', 'type': 'BEHAVIORAL', 'description': 'A peer-mediated, theatre-based intervention.', 'armGroupLabels': ['Theatre']}, {'name': 'Delayed Intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['No Intervention then Theatre']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Kennedy Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Blythe A Corbett, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Blythe Corbett', 'investigatorAffiliation': 'Vanderbilt University'}}}}