Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 5:44 PM
Study NCT ID:
NCT07434856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Sexual Violence and Intimate Partner Violence Primary Prevention Program Implemented in Drinking Establishments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 650}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual Violence Victimization', 'timeFrame': 'Past six months', 'description': 'Self-reported'}, {'measure': 'Sexual Violence Perpetration', 'timeFrame': 'Past six months', 'description': 'Self-report'}, {'measure': 'Intimate Partner Violence Victimization', 'timeFrame': 'Past six months', 'description': 'Self-report, Conflict Tactics Scale (Revised)'}, {'measure': 'Intimate Partner Violence Perpetration', 'timeFrame': 'Past six months', 'description': 'Self-report, Conflict Tactics Scale (Revised)'}], 'secondaryOutcomes': [{'measure': 'Safety Checks', 'timeFrame': 'Six-month follow-up assessments', 'description': 'Self-reported use of safety checks to prevent violence'}, {'measure': 'Bystander intervention', 'timeFrame': 'Six-month follow-up assessments', 'description': 'Self-report of number of times active intervention occurred'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sexual violence', 'intimate partner violence', 'alcohol', 'bars', 'clubs'], 'conditions': ['Intimate Partner Violence (IPV)', 'Sexual Violence', 'Alcohol', 'Safety']}, 'descriptionModule': {'briefSummary': 'The goal of this project is to evaluate the effectiveness of Safe Night Out, a community-level primary violence prevention program offered in drinking establishments in the Sacramento region of California. The main questions this project aims to answer are: 1) Does the Safe Night Out program reduce incidents of sexual violence and intimate partner violence among patrons? 2) Does the Safe Night Out program increase incidents of safety checks of patrons by staff participants? To address these questions, we will enroll 150 staff participants and 500 patron participants from 25 drinking establishments that have implemented the Safe Night Out program (\\~3 staff participants and 10 patron participants per drinking establishment) and 25 drinking establishments that have not implemented the Safe Night Out program (\\~3 staff participants and 10 patron participants per drinking establishment). Participants will complete a baseline and three 6-month follow-up assessments, until 18 month-follow-up.', 'detailedDescription': "The overarching goal of this project is to evaluate the effectiveness of Safe Night Out (SNO), a community-level primary prevention program offered in drinking establishments in the Sacramento region of California. Developed and implemented in 2019 by WEAVE, Inc., Sacramento County's primary domestic violence (DV) provider, SNO aims to train nightlife staff on how to recognize warning signs of sexual violence (SV) and intimate partner violence (IPV), and how to respond through active bystander skills to keep patrons safe. SNO has been tailored for drinking establishments in neighborhoods with high rates of SV and IPV. SNO, a single session education and bystander skills training, is to our knowledge, the only program implemented in drinking establishments in these neighborhoods. Guided by Social Cognitive Theory, Social Norms Theory, and the Bystander Education Model, and in collaboration with our Research Advisory Board, our community-academic team will conduct a quasi-experimental mixed methods evaluation study using a comparative time-interrupted series design. This study is a nonrandomized, quasi-experimental evaluation of an existing community-based violence prevention program. The research team will not prospectively assign individuals or establishments to intervention conditions; rather, outcomes are evaluated in relation to the naturalistic rollout of the Safe Night Out program implemented by a community partner. The aim of the study is to determine the effectiveness of SNO on increasing bystander intervention and reducing SV and IPV at the individual-level (e.g., patrons, staff) and population-level (e.g., census block). Individual-level primary outcomes among patrons include past 6-month SV and past 6-month IPV victimization and perpetration; secondary outcomes among staff include past 6-month increase in bystander intervention and safety checks in drinking establishments. We will also determine the effectiveness of SNO on 2-year average rates of rape, domestic violence assault and domestic violence police calls. We will enroll 25 drinking establishments in the queue at WEAVE to receive SNO training and identify 25 drinking establishments who will not receive the SNO training during the study period. This will allow for comparison between the two groups based on individual-level and staff-level outcomes, before (3 months prior) and after SNO program training (6, 12, and 18-month follow-up) using quantitative survey data (n=500 patrons, 10 per establishment and n=150 staff, 3 per establishment)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Drinking establishments will be identified from a pre-created list that identifies drinking establishments (e.g., bars, clubs) that have received SNO training in the past two years and drinking establishments that have not received SNO training. Staff and patron participants will be recruited from the identified drinking establishments in the Sacramento region of California.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 21 years or older (as required per California law for alcohol servers)\n* Employed and working as a bar owner, manager, or staff member of the drinking establishment that has been recruited for the study (for staff participants)\n* A customer or patron in the past month at the drinking establishment that has been recruited for the study (for patron participants)\n* Ability to speak and understand English\n\nExclusion Criteria:\n\n* Aged 20 years and under\n* Inability to speak and understand English\n* No current employment at a drinking establishment recruited for the study (for staff participants)\n* No history of visiting the drinking establishment in the past month (for patron participants)'}, 'identificationModule': {'nctId': 'NCT07434856', 'briefTitle': 'Evaluation of a Sexual Violence and Intimate Partner Violence Primary Prevention Program Implemented in Drinking Establishments', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'The Safe Night Out Evaluation Study: Evaluation of a Sexual Violence and Intimate Partner Violence Primary Prevention Program Implemented in Drinking Establishments', 'orgStudyIdInfo': {'id': '813932'}, 'secondaryIdInfos': [{'id': 'U01CE003735', 'link': 'https://reporter.nih.gov/quickSearch/U01CE003735', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Staff participants plus Safe Night Out', 'description': 'Staff participants from drinking establishments where Safe Night Out has been implemented', 'interventionNames': ['Behavioral: Safe Night Out Program']}, {'label': 'Staff participants no Safe Night Out', 'description': 'Staff participants from drinking establishments where Safe Night Out has not been implemented', 'interventionNames': ['Behavioral: No Safe Night Out']}, {'label': 'Patron participants plus Safe Night Out', 'description': 'Patron participants from drinking establishments where Safe Night Out has been implemented', 'interventionNames': ['Behavioral: Safe Night Out Program']}, {'label': 'Patron participants no Safe Night Out', 'description': 'Patron participants from drinking establishments where Safe Night Out has not been implemented', 'interventionNames': ['Behavioral: No Safe Night Out']}], 'interventions': [{'name': 'Safe Night Out Program', 'type': 'BEHAVIORAL', 'description': 'A community-level primary violence prevention program offered in drinking establishments.', 'armGroupLabels': ['Patron participants plus Safe Night Out', 'Staff participants plus Safe Night Out']}, {'name': 'No Safe Night Out', 'type': 'BEHAVIORAL', 'description': 'No administration of the Safe Night Out program in drinking establishments.', 'armGroupLabels': ['Patron participants no Safe Night Out', 'Staff participants no Safe Night Out']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jamila K. Stockman, PhD, MPH', 'role': 'CONTACT', 'email': 'jstockman@health.ucsd.edu', 'phone': '858-822-4652'}, {'name': 'Maryam Hussain, PhD', 'role': 'CONTACT', 'email': 'm2hussain@health.ucsd.edu'}], 'overallOfficials': [{'name': 'Jamila K. Stockman, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io/', 'infoTypes': ['SAP'], 'timeFrame': 'The grant requires all data be made publicly available within 30 months of data collection completion. Datasets will be preserved for a minimum of 3 years following project closeout to support replication and secondary use requests approved Data Use Agreements.', 'ipdSharing': 'YES', 'description': 'Although the data are sensitive in nature, as they include information on sexual and intimate partner violence, drinking behavior, and police calls, the grant requires all data be made publicly available within 30 months of data collection completion. De-identified data will be made publicly available on an appropriate data sharing repository.', 'accessCriteria': 'The Data Steward (Dr. Maryam Hussain) will oversee the Qualtrics data logs and ensure quality assurance of those data. Dr Hussain will also create an analysis plan, including all steps for data cleaning and validation, that will become part of the data repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jamila K. Stockman', 'investigatorAffiliation': 'University of California, San Diego'}}}}