Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0
1 other identifier
interventional
667
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2021
CompletedFirst Posted
Study publicly available on registry
June 3, 2021
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2025
CompletedFebruary 4, 2026
January 1, 2025
3.4 years
February 5, 2021
February 3, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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).
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).
Change from Baseline at 12-months
Secondary Outcomes (10)
Barriers to Sexual Assault Bystander Intervention
Change from Baseline at 6-months
Barriers to Sexual Assault Bystander Intervention
Change from Baseline at 12-months
Outcome Expectancies for Intervening
Change from Baseline at 6-months
Outcome Expectancies for Intervening
Change from Baseline at 12-months
Bystander Efficacy Scale
Change from Baseline at 6-months
- +5 more secondary outcomes
Study Arms (6)
RealConsent 1.0 with Alcohol
ACTIVE COMPARATORMen 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).
RealConsent 1.0 with Placebo
ACTIVE COMPARATORMen assigned to complete a web-based multi-media sexual violence and bystander intervention prevention program. Men assigned to a no-alcohol placebo control arm.
RealConsent2.0 with Alcohol
EXPERIMENTALMen 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).
RealConsent2.0 with Placebo
EXPERIMENTALMen 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.
Stress Management with Alcohol
ACTIVE COMPARATORMen assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08).
Stress Management with Placebo
ACTIVE COMPARATORMen assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm.
Interventions
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.
Eligibility Criteria
You may qualify if:
- identify as a man or transgender man, age (21-25)
- consume weight-based amount of alcohol at least three times during the past year
You may not qualify if:
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgia State Universitylead
- University of Nebraska Lincolncollaborator
Study Sites (2)
Georgia State University
Atlanta, Georgia, 30303, United States
University of Nebraska-Lincoln
Lincoln, Nebraska, 68588, United States
Related Publications (1)
Salazar LF, Parrott DJ, DiLillo D, Gervais S, Schipani-McLaughlin AM, Leone R, Swartout K, Simpson L, Moore R, Wilson T, Flowers N, Church H, Baildon A. Study protocol for a randomized controlled trial of RealConsent2.0: a web-based intervention to promote prosocial alcohol-involved bystander behavior in young men. Trials. 2023 Dec 12;24(1):804. doi: 10.1186/s13063-023-07797-w.
PMID: 38087306DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Salazar, Ph.D.
Georgia State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Multiple Principal Investigator
Study Record Dates
First Submitted
February 5, 2021
First Posted
June 3, 2021
Study Start
March 1, 2022
Primary Completion
July 16, 2025
Study Completion
July 16, 2025
Last Updated
February 4, 2026
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- 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.
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.