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Not yet recruiting NCT07527988

Safer Drinking Spaces Study

No phase Interventional Sexual Violence Bystander Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Safe Bars active bystander training.
Who it may be relevant to
Registry conditions: Sexual Violence, Bystander Intervention. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Rigorous Evaluation of Training in Alcohol-Serving Venues for Sexual Violence Prevention

Overview

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: 1. 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? 2. 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? 3. 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? 4. 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.

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.

Interventions

  • Behavioral Safe Bars active bystander training
    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 sce

Primary outcome measures

  • Sexual assault victimization among patrons [Time frame: Baseline to 12 months]
  • Sexual harassment victimization among patrons [Time frame: Baseline to 12 months]
  • Sexual assault victimization among staff [Time frame: Baseline to 12 months]
  • Sexual harassment victimization among staff [Time frame: Baseline to 12 months]
  • Staff bystander behavior [Time frame: Baseline to 6 months]
Secondary outcome measures (5)
  • Staff acceptance of sexual violence [Time frame: Baseline to 6 months]
  • Staff self-efficacy to intervene [Time frame: Baseline to 6 months]
  • Staff perceived safety of the venue [Time frame: Baseline to 6 months]
  • Patron perceived safety of the venue [Time frame: Baseline to 6 months]
  • Patron witnessing venue staff intervention [Time frame: Baseline to 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 3 centers
  • University of Florida — Gainesville
  • Georgia State University — Atlanta
  • RTI International — Durham

Identifiers

NCT: NCT07527988 · U01CE003755 · 1U01CE003755-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗