AzTrials
AzTrials

Alcohol IntoxicationNCT04912492

Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0

A study testing RealConsent1.0, RealConsent2.0 and Stress Management in people with Alcohol Intoxication and Sexual Violence, run by Georgia State University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 to 25 yearsHealthy volunteers can take part
What is being tested?
RealConsent1.0, RealConsent2.0 and Stress Management
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
667 participants
Where
2 sitesUnited States
Study dates
1 Mar 2022to 16 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • identify as a man or transgender man, age (21-25)
  • consume weight-based amount of alcohol at least three times during the past year

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Georgia State University

    Atlanta, Georgia, 30303

  • University of Nebraska-Lincoln

    Lincoln, Nebraska, 68588

Other trials in United States

About this study

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.

Being tested
RealConsent1.0, RealConsent2.0, Stress Management, Alcohol intoxication, No-Alcohol Placebo
Medical subject headings
Alcoholic Intoxication, Helping Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RealConsent1.0Behavioural

    A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors.

  • RealConsent2.0Behavioural

    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 ManagementBehavioural

    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 intoxicationBehavioural

    Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures

  • No-Alcohol PlaceboBehavioural

    Men assigned to an no-alcohol placebo control condition.

Study groups in NCT04912492
Study groupRoleWhat they receive
RealConsent 1.0 with AlcoholActive 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).
Receives: Behavioral: RealConsent1.0; Behavioral: Alcohol intoxication
RealConsent 1.0 with PlaceboActive 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.
Receives: Behavioral: RealConsent1.0; Behavioral: No-Alcohol Placebo
RealConsent2.0 with AlcoholExperimentalMen 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).
Receives: Behavioral: RealConsent2.0; Behavioral: Alcohol intoxication
RealConsent2.0 with PlaceboExperimentalMen 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.
Receives: Behavioral: RealConsent2.0; Behavioral: No-Alcohol Placebo
Stress Management with AlcoholActive comparatorMen assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08).
Receives: Behavioral: Stress Management; Behavioral: Alcohol intoxication
Stress Management with PlaceboActive comparatorMen assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm.
Receives: Behavioral: Stress Management; Behavioral: No-Alcohol Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One-month post-intervention

  2. 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).

    Measured: Change from Baseline at 6-months

  3. 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).

    Measured: Change from Baseline at 12-months

Secondary outcomes (10)

  1. 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.

    Measured: Change from Baseline at 6-months

  2. 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.

    Measured: Change from Baseline at 12-months

  3. 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.

    Measured: Change from Baseline at 6-months

  4. 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.

    Measured: Change from Baseline at 12-months

  5. 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.

    Measured: Change from Baseline at 6-months

  6. 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.

    Measured: Change from Baseline at 12-months

  7. 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.

    Measured: Change from Baseline at 6-months

  8. 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.

    Measured: Change from Baseline at 12-months

  9. 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.

    Measured: Change from Baseline at 6-months

  10. 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.

    Measured: Change from Baseline at 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2021
  2. Study start1 Mar 2022
  3. Primary completion16 Jul 2025
  4. Study completion16 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
667 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04912492
Sponsor's protocol ID
R01AA027517
Status last verified
Jan 2025
First submitted
5 Feb 2021
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 38087306

Questions about this trial

What is this clinical trial studying?

A study testing RealConsent1.0, RealConsent2.0 and Stress Management in people with Alcohol Intoxication and Sexual Violence, run by Georgia State University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bystander behavior (time frame: One-month post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04912492, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in