An interventional study of RealConsent1.0 and RealConsent2.0 in Alcohol Intoxication, Sexual Violence and Helping Behavior, sponsored by Georgia State University. Completed at 2 sites in United States. Open to participants aged 21 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Georgia State University · Not applicable, Interventional, and Prevention
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.
76 studies on the registry are indexed under Alcoholic Intoxication; 17 are open to participants now.
This study's enrollment of 667 is above the median of 135 across 62 interventional studies indexed under Alcoholic Intoxication.
Browse Alcoholic Intoxication studies →Georgia State University is the lead sponsor of 56 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Behavioral: Alcohol intoxication
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 · Behavioral: No-Alcohol Placebo
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: RealConsent2.0 · Behavioral: Alcohol intoxication
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: RealConsent2.0 · Behavioral: No-Alcohol Placebo
Men assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08).
Behavioral: Stress Management · Behavioral: Alcohol intoxication
Men assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm.
Behavioral: Stress Management · Behavioral: No-Alcohol Placebo
A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors.
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.
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.
Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures
Men assigned to an no-alcohol placebo control condition.
Bystander behavior
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.
Time frame: One-month post-intervention
Self-Reported Bystander Behavior
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).
Time frame: Change from Baseline at 6-months
Self-Reported Bystander Behavior
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).
Time frame: Change from Baseline at 12-months
Barriers to Sexual Assault Bystander Intervention
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.
Time frame: Change from Baseline at 6-months
Barriers to Sexual Assault Bystander Intervention
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.
Time frame: Change from Baseline at 12-months
Outcome Expectancies for Intervening
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.
Time frame: Change from Baseline at 6-months
Outcome Expectancies for Intervening
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.
Time frame: Change from Baseline at 12-months
Bystander Efficacy Scale
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.
Time frame: Change from Baseline at 6-months
Bystander Efficacy Scale
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.
Time frame: Change from Baseline at 12-months
Bystander Attitude Scale
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.
Time frame: Change from Baseline at 6-months
Bystander Attitude Scale
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.
Time frame: Change from Baseline at 12-months
Sexual Violence Perpetration
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.
Time frame: Change from Baseline at 6-months
Sexual Violence Perpetration
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.
Time frame: Change from Baseline at 12-months
Plan to share: Yes — 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.
Time frame: One year after the study is completed, all data will be compiled and organized into a single repository at ICPSR.
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.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Georgia State University