Sexual Assault Precursor BehaviorNCT04141839
Evaluation of the Safer Bars Prevention Program for Sexual Assault
A study testing Safer Bars in people with Sexual Assault Precursor Behavior, run by Mary Koss at 1 site in United States.
Trial summary
The goal is to evaluate at three sites the implementation of the Safer Bars sexual assault prevention program. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexual Assault Precursor Behavior
- What is being tested?
- Safer Bars
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 681 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None. No liquor servers are allowed by law to be younger than 19 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sexual Assault Precursor Behavior
- Being tested
- Safer Bars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safer BarsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Delayed intervention: baseline and 3-month assessment prior to receiving the Safer Bars training. Receives: Behavioral: Safer Bars |
| Intervention | Experimental | 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. Receives: Behavioral: Safer Bars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Reported Always Intervening Behavior at 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.
Measured: at baseline and up to 6 months
Did Not Offer Promotions Aimed at Attracting Female Patrons Post-intervention
Self-reported survey items completed by bar owners/managers regarding promotions aimed at attracting female patrons
Measured: at baseline and up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start16 Oct 2020
- Primary completion1 Nov 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sexual Assault Precursor BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A cluster-randomized trial design with crossover to randomize participants at the bar level into intervention and delayed intervention arms.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 681 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Koss
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, Arizona Department of Health Services
- Responsible party
- Sponsor-investigator, Mary Koss, University of Arizona
- Investigators
- Mary P Koss, PhD, Principal investigator, University of ArizonaKelly C Davis, MSW, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141839
- Sponsor's protocol ID
- 1R01AA027263-01
- Status last verified
- Apr 2025
- First submitted
- 22 Oct 2019
- Last updated
- 27 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 38458561Roberts 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.
PubMed 39404150
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safer Bars: A Cluster-Randomized Effectiveness Evaluation of Alcohol-related Sexual Violence Prevention Through Bar Staff Bystander Training
- ClinicalTrials.gov ID
- NCT04141839
- Acronym / sponsor ID
- 1R01AA027263-01
- Conditions
- Sexual Assault Precursor Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 681 participants (actual)
- Lead sponsor
- Mary KossUniversity, hospital or other
- Collaborators
- Arizona State University, Arizona Department of Health Services
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Posted 27 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to evaluate at three sites the implementation of the Safer Bars sexual assault prevention program.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A cluster-randomized trial design with crossover to randomize participants at the bar level into intervention and delayed intervention arms.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Behavioral: Safer BarsDelayed intervention: baseline and 3-month assessment prior to receiving the Safer Bars training. |
| Intervention | Experimental | Behavioral: Safer BarsThis 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None. No liquor servers are allowed by law to be younger than 19 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safer BarsSafer 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. | Behavioural | Control, Intervention |
Primary outcome
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.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38458561Davis 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.
- Results publication: PubMed 39404150Roberts 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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary P Koss, PhD principal investigator
University of Arizona
Kelly C Davis, MSW, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safer Bars in people with Sexual Assault Precursor Behavior, run by Mary Koss at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Reported Always Intervening Behavior at 6 Months (time frame: at baseline and up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04141839, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.