- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04141839
Evaluation of the Safer Bars Prevention Program for Sexual Assault
April 9, 2025 updated by: Mary Koss
Safer Bars: A Cluster-Randomized Effectiveness Evaluation of Alcohol-related Sexual Violence Prevention Through Bar Staff Bystander Training
The goal is to evaluate at three sites the implementation of the Safer Bars sexual assault prevention program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Sexual violence perpetration is robustly associated with social contexts that support high levels of alcohol consumption.
Beginning in 2007, the Arizona Department of Health Services (ADHS) developed and field-tested the Safer Bars curriculum with support from the CDC Rape Prevention and Education (RPE) funding program.
Safer Bars is a bystander prevention training for staff of alcohol serving establishments.
This application proposes a theory-driven, quasi-experimental effectiveness evaluation based at The University of Arizona.
Our approach is significant because few evaluations have measured behavioral outcomes as well as the mediators that explain the observed changes in bystander behavior, or community-level outcomes associated with such interventions.
Specific Aims: the specific aims are to: (1) Test a hypothesized mediational model of individual-level behavioral outcomes based on the Theory of Planned Behavior; (2) assess the effect of the program on bar-level risk management safety policies; and (3) examine the community-level impact of the Safer Bars program on reducing the number of police dispatches in areas with high densities of alcohol-serving establishments.
Methods: A cluster-randomized trial design with crossover to randomize participants at the bar level into intervention and delayed intervention arms is proposed.
Assessments are at baseline, completion of training, and at three and six months post-training.
The sample bars will be selected within a three-mile radius of the three major Arizona universities, all of which have a high density of alcohol-serving establishments adjacent to campus.
Our analytical model will assess a hypothesized moderated mediational model based in the Theory of Planned Behavior (TPB).
Outcomes of interest include: (a) the extent to which Behavioral Intent, the central construct of TPB, mediates bar staff performance of intended bystander behaviors at three-month follow-up and the extent to which this relationship is moderated by personal characteristics and bar environment; (b) the effects of the program on bar-level risk management patron safety policies; and, (c) the community-level effects as demonstrated by number of police dispatches in areas with a high density of alcohol-serving establishments at baseline and at the end of the project using GIS data.
With evidence of efficacy, Safer Bars is feasible for scale-up without excessive financial burden in other states, which all receive RPE funding.
Study Type
Interventional
Enrollment (Actual)
681
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Tucson, Arizona, United States, 85724
- University of Arizona
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Both an employee and a liquor server, security official, or owner/manager of a bar randomly selected to receive Safer Bars training immediately or after an assessment only phase of 4 months and that has not participated in the Safe Bars training in the past 12 months. Accepts healthy volunteers as defined by holding active employment. Employees may opt out of training and/or assessment.
Exclusion Criteria:
- None. No liquor servers are allowed by law to be younger than 19 years old.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control
Delayed intervention: baseline and 3-month assessment prior to receiving the Safer Bars training.
|
Safer Bars, a primary perpetration prevention program based on a bystander intervention model and the theory of planned behavior.
Bar staff are trained to recognize and respond to sexual aggression and its precursors among patrons.
|
|
Experimental: Intervention
This arm with consist of bars randomized to have the Safer Bars training on their premises attended by all their liquor serving staff with assessment directly before and after training (pre/post), and at 3 and 6 months post-training follow-up.
|
Safer Bars, a primary perpetration prevention program based on a bystander intervention model and the theory of planned behavior.
Bar staff are trained to recognize and respond to sexual aggression and its precursors among patrons.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Reported Always Intervening Behavior at 6 Months
Time Frame: at baseline and up to 6 months
|
Self-reported survey items measuring actual behavior (action taken) in response to observation of sexual aggression in the bar environment will be analyzed to identify significant differences post-intervention.
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at baseline and up to 6 months
|
|
Did Not Offer Promotions Aimed at Attracting Female Patrons Post-intervention
Time Frame: at baseline and up to 3 months
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Self-reported survey items completed by bar owners/managers regarding promotions aimed at attracting female patrons
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at baseline and up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean change from baseline in regional rates of sexual assault reported to law enforcement at 5 years.
Time Frame: at baseline and up to 5 years
|
Geographic information system (GIS) mapping will be used to identify the number of police calls to areas with a concentration of trained bars compared to areas that did not receive training.
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at baseline and up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary P Koss, PhD, University of Arizona
- Principal Investigator: Kelly C Davis, MSW, PhD, Arizona State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Davis KC, Koss MP, Lopez EC, Roberts K. Safer Bars: A cluster-randomized effectiveness evaluation of alcohol-related sexual violence prevention through bar staff bystander training. Contemp Clin Trials. 2024 May;140:107488. doi: 10.1016/j.cct.2024.107488. Epub 2024 Mar 6.
- Roberts K, Davis KC, Koss MP, Lopez EC. Feasibility and Acceptability of a Bar-Staff Bystander Intervention Training Program for Reducing Sexual Aggression. J Stud Alcohol Drugs. 2025 Mar;86(2):238-245. doi: 10.15288/jsad.24-00031. Epub 2024 Oct 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 16, 2020
Primary Completion (Actual)
November 1, 2023
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
October 22, 2019
First Submitted That Met QC Criteria
October 24, 2019
First Posted (Actual)
October 28, 2019
Study Record Updates
Last Update Posted (Actual)
April 27, 2025
Last Update Submitted That Met QC Criteria
April 9, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 1R01AA027263-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified responses to survey questions will be provided to qualified investigators upon request with the time frame conditions described below.
Any measures used that were developed or modified by the investigators will be provided as will the study protocol, SAP, and analytic code will be provided at any point after study completion to facilitate replication studies.
IPD Sharing Time Frame
Five years after study completion, or sooner if requested by journal reviewers or colleagues for purposes of writing comments or critiques.
IPD Sharing Access Criteria
Research institution
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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