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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
681

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control
Delayed intervention: baseline and 3-month assessment prior to receiving the Safer Bars training.
Behavioral: Safer Bars
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.
Behavioral: Safer Bars
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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
Self-reported survey items completed by bar owners/managers regarding promotions aimed at attracting female patrons
at baseline and up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
at baseline and up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mary Koss

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Arizona State University
Arizona Department of Health Services

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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