RealConsent2.0 for Preventing Sexual Violence

Recruiting at 1 trial location

Overseen By Dominic Parrott, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Georgia State University

Must not be taking: Antipsychotics, Oral steroids, others

Disqualifiers: Bipolar, Schizophrenia, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

667 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using a medication that would make alcohol consumption unsafe.

What data supports the effectiveness of the RealConsent2.0 treatment for preventing sexual violence?

Research shows that web-based programs combining alcohol use reduction and sexual assault risk reduction can effectively decrease alcohol-related sexual assaults and heavy drinking among college women. RealConsent2.0 builds on this by integrating alcohol use content into bystander intervention training, potentially enhancing its effectiveness in preventing sexual violence. ^{1 2 3 4 5}

Is RealConsent2.0 safe for humans?

The studies reviewed focus on the effectiveness of interventions related to alcohol use and sexual assault risk reduction, but they do not provide specific safety data for RealConsent2.0 or related programs. However, these interventions are generally web-based and educational, which suggests they are likely safe for participants. ^{1 2 4 5 6}

How does the RealConsent2.0 treatment differ from other treatments for alcohol intoxication?

RealConsent2.0 is unique because it integrates alcohol use awareness into a prosocial bystander intervention program, using virtual reality to simulate real-life scenarios. This approach helps both sober and intoxicated individuals recognize and intervene in situations at risk for sexual violence, addressing the immediate effects of alcohol on decision-making, which is not typically covered by other programs. ^{1 2 4 7 8}

Research Team

Laura Salazar, Ph.D.

Principal Investigator

Georgia State University

Eligibility Criteria

This trial is for men aged 21-25 who have consumed alcohol in the past year. It's not suitable for those in a long-term relationship, with certain psychiatric or neurological disorders, significant hearing problems, severe asthma, legal restrictions against drinking, infrequent alcohol consumption, serious head injuries, over 250 pounds weight or seeking treatment for substance use.

Inclusion Criteria

I am a man or transgender man aged between 21 and 25.

Consume weight-based amount of alcohol at least three times during the past year

Exclusion Criteria

Current treatment-seeking for an alcohol use disorder

Significant Hearing Problems: significant hearing problems that would prevent an individual from hearing and responding to the virtual reality task (self-reported and determined)

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete a web-based program, either RealConsent2.0 or a stress management program, with or without alcohol intoxication

1 month

Virtual sessions

Primary Assessment

Bystander behavior assessed via virtual reality environment and self-report measures

1 month post-intervention

Follow-up

Participants are monitored for changes in bystander behavior and other secondary outcomes

12 months

Treatment Details

Interventions

• Alcohol intoxication
• No-Alcohol Placebo
• RealConsent1.0
• RealConsent2.0
• Stress Management

Trial Overview The study tests how alcohol affects young men's willingness to help prevent sexual violence and evaluates RealConsent2.0—a web-based program designed to promote helpful intervention by bystanders at risk situations when alcohol is involved—using VR scenarios and self-reports.

Participant Groups

Group I: RealConsent2.0 with Placebo Experimental Treatment 2 Interventions

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.

Group II: RealConsent2.0 with Alcohol Experimental Treatment 2 Interventions

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).

Group III: Stress Management with Alcohol Active Control 2 Interventions

Men assigned to complete a web-based stress management program. Men assigned to alcohol intoxication arm (target BrAC=.08).

Group IV: Stress Management with Placebo Active Control 2 Interventions

Men assigned to complete a web-based stress management program. Men assigned to a no-alcohol placebo control arm.

Group V: RealConsent 1.0 with Placebo Active Control 2 Interventions

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.

Group VI: RealConsent 1.0 with Alcohol Active Control 2 Interventions

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).

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

University of Nebraska Lincoln

Collaborator

Trials

40

Recruited

13,200+

Findings from Research

In a study involving 327 young adults, increased intoxication levels in bystanders were linked to poorer recall and risk assessment of sexual assault situations, which could hinder effective intervention.

Despite intoxication affecting situation interpretation, it did not impact feelings of personal responsibility or confidence to intervene, suggesting that bystander intervention programs should include strategies to help intoxicated individuals recognize and respond to harmful situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol Intoxication Impairs the Bystander Intervention Process in a Hypothetical Sexual Assault: A Field Investigation. Melkonian, AJ., Ham, LS., Wiersma-Mosley, JD., et al.[2022]

The RealConsent2.0 program is designed to improve bystander intervention in sexual violence situations, specifically addressing the impact of alcohol on decision-making, and is being tested in a randomized controlled trial with 605 young men aged 21-25.

This study is unique as it uses a virtual reality environment to simulate real-life scenarios, allowing researchers to assess how intoxicated and sober bystanders respond to potential sexual violence situations, marking a significant advancement in intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomized controlled trial of RealConsent2.0: a web-based intervention to promote prosocial alcohol-involved bystander behavior in young men. Salazar, LF., Parrott, DJ., DiLillo, D., et al.[2023]

The SAFE program, designed for 25 heavy drinking college men, effectively combines personalized feedback and group workshops to educate participants about alcohol use, consent, and bystander intervention, showing promise in preventing sexual assault.

Preliminary assessments indicate that the SAFE program is feasible and acceptable, with positive feedback on its content and delivery, suggesting it could be a valuable intervention for reducing sexual aggression in high-risk drinking environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual Assault Prevention for Heavy Drinking College Men: Development and Feasibility of an Integrated Approach. Orchowski, LM., Barnett, NP., Berkowitz, A., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial targeting alcohol use and sexual assault risk among college women at high risk for victimization. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Reducing Heavy Episodic Drinking, Incapacitation, and Alcohol-Induced Blackouts: Secondary Outcomes of a Web-Based Combined Alcohol Use and Sexual Assault Risk Reduction Intervention. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Alcohol Intoxication Impairs the Bystander Intervention Process in a Hypothetical Sexual Assault: A Field Investigation. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Study protocol for a randomized controlled trial of RealConsent2.0: a web-based intervention to promote prosocial alcohol-involved bystander behavior in young men. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Scope of Rape Victimization and Perpetration Among National Samples of College Students Across 30 years. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Sexual Assault Prevention for Heavy Drinking College Men: Development and Feasibility of an Integrated Approach. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The Effects of Alcohol Intoxication on Perceptions of Consent and Refusal Indicators in a Fictional Alcohol-Involved Sexual Encounter. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Alcohol Intoxication on Bystander Intervention in a Vignette Depiction of Sexual Assault. [2020]