Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0
NCT ID: NCT04912492
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
667 participants
INTERVENTIONAL
2022-03-01
2026-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention
NCT05701865
Group Alcohol Interventions for College Men
NCT02983864
Nexus of Risk: Sexual Assault, Alcohol Use, and Risky Sex Among College Women
NCT05892692
A Multi-Component Alcohol and Sex Risk Intervention for College Students
NCT05180539
Alcohol Myopia, Objectification, and Sexual Assault
NCT03956238
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
No-Alcohol Placebo
Men assigned to an no-alcohol placebo control condition.
Stress Management with Alcohol
Men assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08).
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.
Alcohol intoxication
Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures
Stress Management with Placebo
Men assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm.
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.
No-Alcohol Placebo
Men assigned to an no-alcohol placebo control condition.
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).
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.
Alcohol intoxication
Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures
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.
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.
No-Alcohol Placebo
Men assigned to an no-alcohol placebo control condition.
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).
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.
Alcohol intoxication
Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Alcohol intoxication
Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures
No-Alcohol Placebo
Men assigned to an no-alcohol placebo control condition.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* consume weight-based amount of alcohol at least three times during the past year
Exclusion Criteria
* 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
21 Years
25 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Nebraska Lincoln
OTHER
Georgia State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Laura F Salazar
Multiple Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laura Salazar, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Georgia State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Georgia State University
Atlanta, Georgia, United States
University of Nebraska-Lincoln
Lincoln, Nebraska, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.