- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04912492
Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0
August 28, 2023 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
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
605
Phase
- 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
- Name: Laura Salazar, Ph.D.
- Phone Number: 404-413-1396
- Email: lsalazar1@gsu.edu
Study Contact Backup
- Name: Dominic Parrott, Ph.D.
- Phone Number: 404-413-6287
- Email: parrott@gsu.edu
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- Recruiting
- Georgia State University
-
Contact:
- Laura F Salazar, PhD
- Phone Number: 404-413-1396
- Email: lsalazar1@gsu.edu
-
Contact:
- Dominic Parrott, PhD
- Phone Number: 4044136287
- Email: Parrott@gsu.edu
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68588
- Recruiting
- University of Nebraska-Lincoln
-
Contact:
- David DiLillo, PhD
- Phone Number: 402-472-3297
- Email: ddilillo2@unl.edu
-
Contact:
- Sarah Gervais, PhD
- Phone Number: 4024723721
- Email: sgervais2@unl.edu
-
-
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
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 |
Intervention / Treatment |
---|---|
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).
|
A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors.
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.
|
A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors.
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).
|
Men assigned to moderate alcohol dose condition (target BrAC .08%)
with NIAAA approved alcohol administration procedures
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.
|
Men assigned to an no-alcohol placebo control condition.
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).
|
Men assigned to moderate alcohol dose condition (target BrAC .08%)
with NIAAA approved alcohol administration procedures
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.
|
Men assigned to an no-alcohol placebo control condition.
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
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
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
Collaborators
Investigators
- Principal Investigator: Laura Salazar, Ph.D., Georgia State University
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)
March 1, 2022
Primary Completion (Estimated)
August 31, 2025
Study Completion (Estimated)
February 28, 2026
Study Registration Dates
First Submitted
February 5, 2021
First Submitted That Met QC Criteria
June 2, 2021
First Posted (Actual)
June 3, 2021
Study Record Updates
Last Update Posted (Actual)
August 29, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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