Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT03473067
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2017-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Community Level Primary Prevention of Dating and Sexual Violence in Middle Schools
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057191', 'term': 'Capacity Building'}], 'ancestors': [{'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D000096763', 'term': 'Pandemic Preparedness'}, {'id': 'D004189', 'term': 'Disaster Planning'}, {'id': 'D004190', 'term': 'Disasters'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D003140', 'term': 'Communicable Disease Control'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4344}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2017-08-28', 'studyFirstSubmitQcDate': '2018-03-21', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Teacher Engagement in Bystander Intervention', 'timeFrame': 'Over 6 months', 'description': 'Rates of bystander intervention behavior among teachers'}, {'measure': 'Perceptions of Social Norms', 'timeFrame': 'Change from baseline to 6 months', 'description': 'A series of items were developed for the purpose of the present study to assess student perceptions of peer norms regarding dating and sexual violence. Items are scored on a range of 0% - 100% to indicate the percent of peers within the school that would endorse each item. Scores for each item will be examined individually. Positive scores on this measure are indicated when respondents perceive a greater number of their peers would endorse healthy behavior.'}], 'primaryOutcomes': [{'measure': 'Sexual Violence Victimization', 'timeFrame': 'Over 6 months', 'description': 'Rates of sexual violence victimization'}, {'measure': 'Dating Violence Victimization', 'timeFrame': 'Over 6 months', 'description': 'Rates of dating violence victimization'}, {'measure': 'Sexual Violence Perpetration', 'timeFrame': 'Over 6 months', 'description': 'Rates of sexual violence perpetration'}, {'measure': 'Dating Violence Perpetration', 'timeFrame': 'Over 6 months', 'description': 'Rates of dating violence perpeptration'}], 'secondaryOutcomes': [{'measure': 'Bystander Intervention', 'timeFrame': 'Over 6 months', 'description': 'Rates of bystander intervention'}, {'measure': 'Attitudes Towards Violence', 'timeFrame': 'Change from baseline to 6 months', 'description': 'Attitudes towards violence scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Violence']}, 'descriptionModule': {'briefSummary': 'Dating and sexual violence are significant public health concerns occurring on a continuum of severity across the lifespan, with serious consequences to victims and society. The present research advances the science of prevention by rigorously evaluating a comprehensive social norms marketing campaign to promote community-level change in dating and sexual violence in middle schools. Partnership between researchers and a CDC Rape Prevention and Education Program (RPE) funded agency is a core feature of this work, and aims to build community capacity to implement and evaluate violence prevention efforts, and promote the subsequent uptake of social norms marketing campaigns as a strategy for reducing dating and sexual violence among youth.', 'detailedDescription': 'In a group cluster trial, a comprehensive, tailored, data-based social norms marketing campaign that addresses misperceptions of: 1) the acceptability of dating and sexual violence; 2) gender roles; 3) sexual activity; 4) sexual communication/consent; 5) support for victims; and 6) bystander intervention will be evaluated among middle schools. Poster messaging will be paired with several systematic efforts to diffuse program content through the community, including a Lunch and Learn Teacher Training, Social Norms Video, Teacher Workbook, Parent Mailing, and Parent Information Session. A member of the researcher-practitioner team, designated as a School Resource Provider, will oversee campaign implementation in partnership with a teacher champion. The Resource Provider will also track campaign intensity, assess campaign credibility through intercept interviews with teachers and students, work with teachers to infuse messaging into classroom activities, and assist the teacher champion with addressing "kick-back" to the campaign. Outcome assessments will be completed by teachers, administrators and students. Towards the goal of exploring the role of other environmental factors as moderators of program effects, school administrators will assess their community readiness to develop and implement school dating and sexual violence prevention policy, in general, and social norms marketing, in particular. A neighborhood scan will also be conducted to estimate the density of nearby outlets associated with gender-based personal violence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Student at a middle school or teacher/administrator at a middle school\n* Provide student assent and parental consent as specified in protocol or provide adult consent for study participation\n\nExclusion Criteria:\n\n• None'}, 'identificationModule': {'nctId': 'NCT03473067', 'briefTitle': 'Community Level Primary Prevention of Dating and Sexual Violence in Middle Schools', 'organization': {'class': 'OTHER', 'fullName': 'Lifespan'}, 'officialTitle': 'Community Level Primary Prevention of Dating and Sexual Violence in Middle Schools', 'orgStudyIdInfo': {'id': '1U01CE002651', 'link': 'https://reporter.nih.gov/quickSearch/1U01CE002651', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Social Norms Marketing', 'description': 'This arm includes a social norms marketing campaign tailored to the school.', 'interventionNames': ['Behavioral: Social Norms Marketing Campaign']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Capacity Building', 'description': 'This arm includes a series of teacher training, and parent engagement meetings, with the goal of building capacity to address violence in the school.', 'interventionNames': ['Other: Capacity Building']}], 'interventions': [{'name': 'Social Norms Marketing Campaign', 'type': 'BEHAVIORAL', 'otherNames': ['Your Voice Your Data'], 'description': 'This poster based marketing campaign is designed to correct inaccurate perceptions of norms regarding violence.', 'armGroupLabels': ['Social Norms Marketing']}, {'name': 'Capacity Building', 'type': 'OTHER', 'description': 'Schools will participate in teacher training and parent training.', 'armGroupLabels': ['Capacity Building']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02904', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Lindsay M. Orchowski, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rhode Island Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lifespan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brown University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Psychologist', 'investigatorFullName': 'Lindsay Orchowski Ph.D.', 'investigatorAffiliation': 'Lifespan'}}}}