Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-03-14 @ 3:43 PM
Study NCT ID:
NCT03205059
Status:
UNKNOWN
Last Update Posted:
2019-01-07
First Post:
2017-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Evidence-based Approach for Bullying Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058445', 'term': 'Bullying'}, {'id': 'D000077224', 'term': 'Cyberbullying'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D000374', 'term': 'Aggression'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000071277', 'term': 'Harassment, Non-Sexual'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-03', 'studyFirstSubmitDate': '2017-06-28', 'studyFirstSubmitQcDate': '2017-06-28', 'lastUpdatePostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in bullying/cyberbullying perpetration in the past two years', 'timeFrame': 'Post-test (within 2 weeks of completing final session/module of the intervention), 12-month follow-up, 24-month follow-up', 'description': 'The investigators will assess (via questionnaire) key study variables regarding bullying and cyberbullying and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the active comparator group at a post-test assessment and 12-month and 24-month follow-up assessments.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bullying', 'Cyberbullying', 'Substance Use', 'Substance Abuse']}, 'descriptionModule': {'briefSummary': 'This Phase II SBIR project is designed to address the critical public health problem of bullying and cyberbullying among middle school age youth. The project involves developing and testing bullying and cyberbullying prevention materials, including interactive classroom sessions and corresponding serious games, based on the evidence-based substance abuse prevention approach called Life Skills Training. The product has the potential to fill a gap in the intervention tools currently available to schools that can be widely disseminated throughout the country using existing marketing and dissemination channels and decrease the adverse consequences of bullying and cyberbullying as well as substance abuse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Middle school aged-youth\n\nExclusion Criteria:\n\n* Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites'}, 'identificationModule': {'nctId': 'NCT03205059', 'briefTitle': 'An Evidence-based Approach for Bullying Prevention', 'organization': {'class': 'INDUSTRY', 'fullName': 'National Health Promotion Associates, Inc.'}, 'officialTitle': 'An Evidence-based Approach for Bullying Prevention', 'orgStudyIdInfo': {'id': 'R44HD074319-02', 'link': 'https://reporter.nih.gov/quickSearch/R44HD074319-02', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LST MS curriculum+ Bullying/Cyberbullying serious game', 'interventionNames': ['Behavioral: LST MS curriculum+ Bullying/Cyberbulling serious game']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LST MS curriculum', 'interventionNames': ['Behavioral: LST MS curriculum']}], 'interventions': [{'name': 'LST MS curriculum+ Bullying/Cyberbulling serious game', 'type': 'BEHAVIORAL', 'description': 'The prevention materials for middle school bullying and cyberbullying will (1) utilize both interactive classroom sessions and serious/educational games (digital games used to educate in an entertaining format); (2) positively change social norms surrounding bullying and cyberbulling; (3) challenge positive expectancies about bullying and cyberbullying; (4) enhance protective factors by building social, self-regulation, and relationship skills throughout the interactive learning and behavioral rehearsal; and (5) include booster sessions.', 'armGroupLabels': ['LST MS curriculum+ Bullying/Cyberbullying serious game']}, {'name': 'LST MS curriculum', 'type': 'BEHAVIORAL', 'description': 'The evidence-based LifeSkills Training program has been successfully used as a universal, school-based substance abuse and violence prevention program for middle school youth. The goals of the LST program are to teach youth the personal self-management skills, social skills, and other life skills needed to successfully resist drug and alcohol use, navigate developmental tasks, increase resilience, and facilitate healthy psychosocial development.', 'armGroupLabels': ['LST MS curriculum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10604', 'city': 'White Plains', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Williams', 'role': 'CONTACT', 'email': 'cwilliams@nhpamail.com', 'phone': '914-421-2525'}], 'facility': 'National Health Promotion Associates', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}], 'centralContacts': [{'name': 'Christopher Williams', 'role': 'CONTACT', 'email': 'cwilliams@nhpamail.com', 'phone': '9144212525'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Health Promotion Associates, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Vice President', 'investigatorFullName': 'Christopher Williams', 'investigatorAffiliation': 'National Health Promotion Associates, Inc.'}}}}