Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0

February 3, 2026 updated by: Laura F Salazar, Georgia State University
Sexual violence (SV) is a significant public health problem particularly among 18-24 year old populations. A major risk factor for SV is alcohol use, which via its negative impact on cognitive abilities and decision-making acts as a barrier to intervening in situations at-risk for a SV. This study has two main goals: (1) to determine the effects of proximal alcohol use on young (age 21 to 25) men's prosocial bystander behavior in situations considered at-risk for SV, and (2) to determine the efficacy of an evidence-based, web-based program called RealConsent, which has been augmented to include alcohol-specific content within the context of bystander SV ("RealConsent2.0"), on men's prosocial bystander behavior. The primary study endpoint is prosocial bystander behavior and will be assessed via two modes: (1) a virtual reality (VR) environment ("B-SAVE") and (2) a validated self-report measure of bystander behavior that has been modified to include assessment of proximal alcohol use and presence of alcohol within the context.

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.

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.
667

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

  • Name: Dominic Parrott, Ph.D.
  • Phone Number: 404-413-6287
  • Email: parrott@gsu.edu

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Georgia State University
    • Nebraska
      • Lincoln, Nebraska, United States, 68588
        • University of Nebraska-Lincoln

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

21 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • identify as a man or transgender man, age (21-25)
  • consume weight-based amount of alcohol at least three times during the past year

Exclusion Criteria:

  • weight over 250 pounds
  • current treatment-seeking for an alcohol use disorder
  • any medical or psychiatric condition, as well as current use of a medication, that would contraindicate alcohol administration.
  • in a relationship over 6 months
  • married/living together
  • Neurological Disorder: diagnosis of a neurological disorder
  • Psychiatric Disorder: past or current diagnosis of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, or any other psychotic disorder
  • Treatment for Alcohol or Drug Use: currently being treated for alcohol, or drug problems; currently interested in seeking treatment for drinking or drug use
  • Physical disability: anh physical disability that would prevent an individual from participating in the virtual reality task (self-report and determined)
  • Significant Hearing Problems: significant hearing problems that would prevent an individual from hearing and responding to the virtual reality task (self-reported and determined)
  • Cardiac Pacemaker
  • Asthma: emergency room visit related to asthma in the past year; use of inhaler more frequently when drinking alcohol; use of oral steroid treatments for asthma in the past year;
  • Legal: any legal restrictions against drinking (e.g., as a condition of probation or parole)
  • Alcohol Abstinence: individuals who consume alcohol monthly or less; individuals who have consumed the amount of alcohol they would be expected to drink during the lab session (determined by their weight) less than 3 times in the last year
  • Head Injury: any past serious head injuries (as indicated by HELPS Brain Injury Screening Tool)
  • Acute Psychiatric Symptomatology: elevated psychological distress as indicated by a score greater than 65 on the Brief Symptom Inventory

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: Parallel Assignment
  • Masking: Double

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.
Active Comparator: RealConsent 1.0 with Alcohol
Men assigned to complete a web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to alcohol intoxication arm (target breath alcohol concentration (BrAC=.08).
Behavioral: RealConsent1.0
A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors.
Behavioral: Alcohol intoxication
Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures
Active Comparator: RealConsent 1.0 with Placebo
Men assigned to complete a web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to a no-alcohol placebo control arm.
Behavioral: RealConsent1.0
A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors.
Behavioral: No-Alcohol Placebo
Men assigned to an no-alcohol placebo control condition.
Experimental: RealConsent2.0 with Alcohol
Men assigned to complete a revised web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to alcohol intoxication arm (target BrAC=.08).
Behavioral: Alcohol intoxication
Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures
Behavioral: RealConsent2.0
A revised and updated web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors, but also integrates new program segments into RealConsent 1.0 specific to how alcohol use can inhibit SV intervention at multiple steps of the decision-making process.
Experimental: RealConsent2.0 with Placebo
Men assigned to complete a revised web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to a no-alcohol placebo control arm.
Behavioral: No-Alcohol Placebo
Men assigned to an no-alcohol placebo control condition.
Behavioral: RealConsent2.0
A revised and updated web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors, but also integrates new program segments into RealConsent 1.0 specific to how alcohol use can inhibit SV intervention at multiple steps of the decision-making process.
Active Comparator: Stress Management with Alcohol
Men assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08).
Behavioral: Alcohol intoxication
Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures
Behavioral: Stress Management
A web-based multimedia program designed to help individuals recognize the symptoms and sources of stress and provide them with a wide variety of powerful tools for managing stress.
Active Comparator: Stress Management with Placebo
Men assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm.
Behavioral: No-Alcohol Placebo
Men assigned to an no-alcohol placebo control condition.
Behavioral: Stress Management
A web-based multimedia program designed to help individuals recognize the symptoms and sources of stress and provide them with a wide variety of powerful tools for managing stress.

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
Bystander behavior
Time Frame: One-month post-intervention
Bystander behavior will be assessed by a virtual reality (VR) environment titled, Bystanders in Sexual Assault Virtual Environments (B-SAVE). Participants experience a virtual "house party" and are exposed to 5 situations in which they can either intervene or not. Participants are prompted at two points (with a flashing microphone icon) to verbalize their response in that situation - thus providing 10 opportunities to intervene in sexual risk situations. Verbal responses to each situation are recorded and coded to assess for bystander behavior.
One-month post-intervention
Self-Reported Bystander Behavior
Time Frame: Change from Baseline at 6-months
The 44-item Bystander Behavior Scale involves a description of a scenario in which participants are asked if they were exposed to the scenario, did they engage in the behavior (yes/no), if they had been drinking alcohol (yes/no) and if alcohol was present (yes/ no). Response options range from 0 (no) to 1 (yes) for each of the items. A total score for bystander behavior is calculated ranging from 0 (minimum) to 30 (maximum), with higher scores indicating greater bystander behavior in the last three-months. alcohol (yes/no) and if alcohol was present (yes/ no).
Change from Baseline at 6-months
Self-Reported Bystander Behavior
Time Frame: Change from Baseline at 12-months
The 44-item Bystander Behavior Scale involves a description of a scenario in which participants are asked if they were exposed to the scenario, did they engage in the behavior (yes/no), if they had been drinking alcohol (yes/no) and if alcohol was present (yes/ no). Response options range from 0 (no) to 1 (yes) for each of the items. A total score for bystander behavior is calculated ranging from 0 (minimum) to 30 (maximum), with higher scores indicating greater bystander behavior in the last three-months. alcohol (yes/no) and if alcohol was present (yes/ no).
Change from Baseline at 12-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
Outcome Expectancies for Intervening
Time Frame: Change from Baseline at 6-months
The 17-item Outcome Expectancies for Intervening Scale assess outcome expectancies for intervening. Mean scores ranging from 1 (minimum) to 7 (maximum). Higher scores indicate greater positive expectancies for intervening.
Change from Baseline at 6-months
Outcome Expectancies for Intervening
Time Frame: Change from Baseline at 12-months
The 17-item Outcome Expectancies for Intervening Scale assess outcome expectancies for intervening. Mean scores ranging from 1 (minimum) to 7 (maximum). Higher scores indicate greater positive expectancies for intervening.
Change from Baseline at 12-months
Bystander Efficacy Scale
Time Frame: Change from Baseline at 6-months
14-item Bystander Efficacy Scale assess bystander confidence to intervene, with response options ranging from 0 % (minimum) to 100% (maximum). A score is created by subtracting the mean of these 14 items from 100 to create a scale of perceived efficacy. Higher scores indicate greater bystander efficacy.
Change from Baseline at 6-months
Bystander Efficacy Scale
Time Frame: Change from Baseline at 12-months
14-item Bystander Efficacy Scale assess bystander confidence to intervene, with response options ranging from 0 % (minimum) to 100% (maximum). A score is created by subtracting the mean of these 14 items from 100 to create a scale of perceived efficacy. Higher scores indicate greater bystander efficacy.
Change from Baseline at 12-months
Sexual Violence Perpetration
Time Frame: Change from Baseline at 6-months
The 35 items Sexual Experience Survey will be used to assess sexual violence perpetration. Participants indicate the number of times that they did each act ranging from 0 (never) to 3 (3 or more times), with total scores ranging from 0 to 105 with greater scores indicating more perpetration. The mutually exclusive scoring system will be used. The goal is to count people only once according to the most severe act perpetrated.
Change from Baseline at 6-months
Sexual Violence Perpetration
Time Frame: Change from Baseline at 12-months
The 35 items Sexual Experience Survey will be used to assess sexual violence perpetration. Participants indicate the number of times that they did each act ranging from 0 (never) to 3 (3 or more times), with total scores ranging from 0 to 105 with greater scores indicating more perpetration. The mutually exclusive scoring system will be used. The goal is to count people only once according to the most severe act perpetrated.
Change from Baseline at 12-months
Barriers to Sexual Assault Bystander Intervention
Time Frame: Change from Baseline at 6-months
The 16-item Barriers to Sexual Assault Bystander Intervention Scale assess barriers to intervention. Mean scores range from 1 (minimum) to 7 (maximum), with higher scores indicate more barriers to intervention.
Change from Baseline at 6-months
Barriers to Sexual Assault Bystander Intervention
Time Frame: Change from Baseline at 12-months
The 16-item Barriers to Sexual Assault Bystander Intervention Scale assess barriers to intervention. Mean scores range from 1 (minimum) to 7 (maximum), with higher scores indicate more barriers to intervention.
Change from Baseline at 12-months
Bystander Attitude Scale
Time Frame: Change from Baseline at 6-months
The 12-item Bystander Attitudes Scale assesses bystander intentions. Response options ranging from 1 (minimum) to 5 (maximum), with greater mean scores indicate higher intentions of intervening.
Change from Baseline at 6-months
Bystander Attitude Scale
Time Frame: Change from Baseline at 12-months
The 12-item Bystander Attitudes Scale assesses bystander intentions. Response options ranging from 1 (minimum) to 5 (maximum), with greater mean scores indicate higher intentions of intervening.
Change from Baseline at 12-months

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.
Georgia State University

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.
University of Nebraska Lincoln

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: Laura Salazar, Ph.D., Georgia 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.
March 1, 2022

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.
July 16, 2025

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.
July 16, 2025

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).
February 5, 2021

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.
June 2, 2021

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.
June 3, 2021

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.
February 4, 2026

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.
February 3, 2026

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.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • R01AA027517 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the grant period, access to the data will be provided through the Inter- University Consortium for Political and Social Research (ICPSR). Users will be required to agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data source and funders. One year after the study is completed, all data will be compiled and organized into a single repository at ICPSR. Data will be made publicly available through ICPSR's website.

IPD Sharing Time Frame

One year after the study is completed, all data will be compiled and organized into a single repository at ICPSR.

IPD Sharing Access Criteria

Users will be required to agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgment of the data source and funders.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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