Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-01-02 @ 11:52 AM
Study NCT ID:
NCT01978795
Status:
COMPLETED
Last Update Posted:
2013-11-08
First Post:
2013-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interactive Training in Sports Concussion Prevention and Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-06', 'studyFirstSubmitDate': '2013-10-23', 'studyFirstSubmitQcDate': '2013-11-06', 'lastUpdatePostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Implementation of effective concussion management guidelines', 'timeFrame': '3 months post intervention'}], 'primaryOutcomes': [{'measure': 'Change in youth athlete and parent knowledge of effective sports concussion management from before and after intervention exposure', 'timeFrame': 'Pre: Participants completed the measure an average of 30 minutes prior to being exposed to the intervention. Post: Participants completed the measure an average of 30 minutes after exposure to the intervention'}], 'secondaryOutcomes': [{'measure': 'Change in youth athlete and parent ratings of self-efficacy in sports concussion management', 'timeFrame': 'Pre: Participants completed the measure an average of 30 minutes prior to being exposed to the intervention. Post: Participants completed the measure an average of 30 minutes after exposure to the intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['concussion', 'high school', 'web-based training', 'school-based health care'], 'conditions': ['Concussion']}, 'referencesModule': {'references': [{'pmid': '25438964', 'type': 'DERIVED', 'citation': 'Glang AE, Koester MC, Chesnutt JC, Gioia GA, McAvoy K, Marshall S, Gau JM. The effectiveness of a web-based resource in improving postconcussion management in high schools. J Adolesc Health. 2015 Jan;56(1):91-7. doi: 10.1016/j.jadohealth.2014.08.011. Epub 2014 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated Brain 101: The Concussion Play book, an intervention that provides education and resources on concussion management for high schools. The study hypotheses were that athletes and parents who viewed the Brain 101 program would demonstrate increased knowledge and self efficacy in concussion management, and that use of the intervention would positively affect school concussion management practices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria for participating schools:\n\n* athletic trainer (AT) on staff or contracted by school for services\n* school access to a high-speed internet connection\n* agreement to expose all students participating in fall sports to the training.\n\nExclusion Criteria:\n\n* didn't meet inclusion criteria"}, 'identificationModule': {'nctId': 'NCT01978795', 'briefTitle': 'Interactive Training in Sports Concussion Prevention and Management', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oregon Center for Applied Science, Inc.'}, 'officialTitle': 'The Effectiveness of a Web-Based Resource in Improving Post-Concussion Management in High Schools', 'orgStudyIdInfo': {'id': 'HD056610'}, 'secondaryIdInfos': [{'id': 'R44HD056610', 'link': 'https://reporter.nih.gov/quickSearch/R44HD056610', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brain 101 website', 'description': 'Brain 101: The Concussion Play book is a web-based, stand-alone guide for school leaders on effective policies and practices in concussion management. The website offers a school-wide approach to preventing and managing sports concussion, including a) training for educators, athletics staff, students, and parents; b) guidelines for creating a concussion management team; and c) information on strategies for supporting students in the classroom following concussion.', 'interventionNames': ['Other: Brain 101 website']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Brain 101 website', 'type': 'OTHER', 'description': 'Brain 101: The Concussion Play book is a web-based, stand-alone guide for school leaders on effective policies and practices in concussion management. Consistent with the literature on effective school-based change efforts, the website offers a comprehensive, school-wide approach to preventing and managing sports concussion, including training for educators, athletics staff, students, and parents. The website presents guidelines for creating a concussion management team (CMT) that meets regularly to support students as they return to academics, extra-curricular activities, and athletics. It also includes information on strategies for supporting students in the classroom following concussion (e.g., designing reduced school schedules, monitoring school performance following concussion).', 'armGroupLabels': ['Brain 101 website']}, {'name': 'Control', 'type': 'OTHER', 'description': 'At control schools, parents viewed Centers for Disease Control materials on safe teen drivers. Athletes viewed web-based materials about teens staying safe on the job.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Center for Applied Science', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Ann E Glang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Center for Applied Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Center for Applied Science, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Ann Glang', 'investigatorAffiliation': 'Oregon Center for Applied Science, Inc.'}}}}