- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07527988
Safer Drinking Spaces Study (SDSS)
Rigorous Evaluation of Training in Alcohol-Serving Venues for Sexual Violence Prevention
The goal of this study is to evaluate the active bystander training provided by Safe Bars, Inc. and their local chapter organizations to staff at alcohol-serving establishments (e.g., bars). The training aims to improve norms about violence, create safer environments by teaching staff to intervene in potentially harmful situations, and help prevent sexual violence in the venue community. The study will examine the implementation and effectiveness of the training. The main questions it aims to answer are:
- Do staff and patrons at venues that have received Safe Bars training experience lower rates of sexual violence at the venue than staff and patrons at venues that have not received the training?
- Are staff at venues that have received Safe Bars training more likely to intervene in potentially risky situations than staff at venues that have not received the training?
- What characteristics of venue environments and staff and patron beliefs and perceptions are responsible for effects of the training on sexual violence and bystander behavior outcomes?
- What characteristics and conditions are necessary for effective Safe Bars implementation and improved staff and patron outcomes?
Researchers will compare staff and patron experiences at venues that have received the training with venues that are offered a delayed training. Staff and patron participants will be asked to complete surveys over about 12 months, research staff will conduct observations of training and observations in the venues, and selected venue managers and staff will be asked to complete individual interviews.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The prevalence of sexual violence (SV) is still unacceptably high in the United States and alcohol-serving venues (e.g., bars, nightclubs) are the most common public setting where SV occurs. Extensive research confirms that the venue environment, coupled with alcohol consumption, is associated with increased rates of SV. Trainings for venue staff, which combine bystander intervention skill-building with discussion of organization-level changes to policies, norms, and environmental characteristics, are a promising approach to prevent SV because they address both individual and community (i.e., venue)-level risk and protective factors. To date, these trainings have not been rigorously evaluated in terms of SV outcomes. There is a critical need to test the effectiveness of prevention approaches that change both individual behavior in venues and characteristics of venue settings to reduce SV among staff and patrons.
The proposed study will assess the effectiveness of Safe Bars active bystander training, which involves training and support for alcohol-serving venues, for primary prevention of SV. Safe Bars, Inc. has implemented trainings for venue staff since 2013, with 135 venues in 15 states trained either directly by Safe Bars, Inc. or by one of their trained chapter organizations since 2022. Grounded in established theories of behavior change, Safe Bars promotes anti-violence norms and creates safer environments by increasing bystander intervention among venue staff and generating venue-level solutions to preventing SV (such as improving policies or increasing anti-violence messaging in the venue).
In a prior study, the research team established the feasibility of evaluating venue-based SV prevention by conducting an evaluability assessment, including formative research and pilot testing of procedures. Informed by the results, the proposed evaluation uses a Hybrid Type 1 effectiveness-implementation design to assess the impact of Safe Bars training on SV among venue staff and patrons (Aim 1); examine venue environment characteristics, staff and patron psychosocial factors, and staff bystander intervention behaviors as mediators of Safe Bars training effects on SV outcomes (Aim 2); and examine potential moderating characteristics necessary for effective Safe Bars implementation and improved staff and patron outcomes (Aim 3). The study will use repeated surveys of patrons and staff at 15 intervention and 15 waitlist control venues, semi-structured interviews with managers and staff, training observations, venue observations, and Safe Bars implementation records to evaluate effectiveness and implementation and measure costs.
Safe Bars training is manualized for dissemination and has shown strong community acceptability. The outcomes of this study are expected to have an important positive impact by expanding the evidence base for community-level SV prevention and informing future implementation of venue-focused interventions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marni Kan
- Phone Number: 919-485-2756
- Email: mkan@rti.org
Study Contact Backup
- Name: Nichole Scaglione
- Phone Number: (352) 294-0548
- Email: nscaglione@ufl.edu
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- University of Florida
-
Contact:
- Nichole Scaglione
- Phone Number: (352) 294-0548
- Email: nscaglione@ufl.edu
-
-
Georgia
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Atlanta, Georgia, United States, 30302
- Georgia State University
-
Contact:
- Andrew Rizzo
- Phone Number: 999-999-9999
- Email: drewrizzo@outlook.com
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North Carolina
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Durham, North Carolina, United States, 27713
- RTI International
-
Contact:
- Marni Kan
- Phone Number: 9194852756
- Email: mkan@rti.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 18 years old
- Able to read and speak English
- Employee or patron of participating venues
Exclusion Criteria:
- Has any condition that, in the opinion of the PI or their designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Safe Bars Training
Venues assigned to this arm will receive the Safe Bars active bystander training for their staff after baseline data collection for the study.
|
Safe Bars, Inc. (SBI)'s active bystander training is a primary prevention approach with three main components designed to (1) educate venue staff about the associations between alcohol and SV, (2) build bystander intervention skills and self-efficacy among venue staff, and (3) generate venue-level solutions to SV prevention.
The 2.5-hour initial training combines didactic teaching with group brainstorming and practice-based role plays to teach staff actions they can take in response to risky scenarios observed in venue settings.
Beyond increasing staff knowledge and skill, the training is also designed to spur venues' plans to support long-term culture change that reflects their local context and needs.
After the initial training, SBI maintains a regular schedule of follow-up with trained venues to offer implementation support and access to SBI's other trainings in de-escalation and allyship.
|
|
Other: Wait-List Control
Venues assigned to this arm will be offered the Safe Bars active bystander training for their staff after the 6-month follow-up data collection for the study.
They will not receive an intervention during the first 6 months of the study.
|
Safe Bars, Inc. (SBI)'s active bystander training is a primary prevention approach with three main components designed to (1) educate venue staff about the associations between alcohol and SV, (2) build bystander intervention skills and self-efficacy among venue staff, and (3) generate venue-level solutions to SV prevention.
The 2.5-hour initial training combines didactic teaching with group brainstorming and practice-based role plays to teach staff actions they can take in response to risky scenarios observed in venue settings.
Beyond increasing staff knowledge and skill, the training is also designed to spur venues' plans to support long-term culture change that reflects their local context and needs.
After the initial training, SBI maintains a regular schedule of follow-up with trained venues to offer implementation support and access to SBI's other trainings in de-escalation and allyship.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual assault victimization among patrons
Time Frame: Baseline to 12 months
|
Endorsement (yes) to any of 5 items asking about experiences in the past month at the venue
|
Baseline to 12 months
|
|
Sexual harassment victimization among patrons
Time Frame: Baseline to 12 months
|
Endorsement (yes) of any of 8 items asking about experiences in the past month at the venue
|
Baseline to 12 months
|
|
Sexual assault victimization among staff
Time Frame: Baseline to 12 months
|
Endorsement (yes) to any of 5 items asking about experiences in the past month at the venue
|
Baseline to 12 months
|
|
Sexual harassment victimization among staff
Time Frame: Baseline to 12 months
|
Endorsement (yes) of any of 8 items asking about experiences in the past month at the venue
|
Baseline to 12 months
|
|
Staff bystander behavior
Time Frame: Baseline to 6 months
|
Proportion of opportunities (out of 17 possible) in which staff reported that they intervened in a risky situation
|
Baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Staff acceptance of sexual violence
Time Frame: Baseline to 6 months
|
Average of 6 items on a 1-5 scale; higher scores indicate more acceptance
|
Baseline to 6 months
|
|
Staff self-efficacy to intervene
Time Frame: Baseline to 6 months
|
Average of 17 items on a 1-5 scale; higher scores indicate more self-efficacy
|
Baseline to 6 months
|
|
Staff perceived safety of the venue
Time Frame: Baseline to 6 months
|
Average of 5 items on a 1-5 scale; higher scores indicate less perceived safety
|
Baseline to 6 months
|
|
Patron perceived safety of the venue
Time Frame: Baseline to 6 months
|
Average of 5 items on a 1-5 scale; higher scores indicate less perceived safety
|
Baseline to 6 months
|
|
Patron witnessing venue staff intervention
Time Frame: Baseline to 6 months
|
Proportion of opportunities (out of 17 possible) in which patrons reported that they saw staff intervene in a risky situation
|
Baseline to 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- U01CE003755 (U.S. NIH Grant/Contract)
- 1U01CE003755-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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