Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0 (NCT04912492) | Clinical Trial Compass
CompletedNot Applicable
Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0
United States667 participantsStarted 2022-03-01
Plain-language 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.
Who can participate
Age range
21 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 consu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.