RealConsent2.0 for Preventing Sexual Violence

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how alcohol affects young men's ability to intervene and prevent situations that might lead to sexual violence. It also tests a new version of a web-based program called RealConsent2.0, an educational intervention, to determine if it can enhance these prosocial behaviors. Participants will encounter various scenarios, some involving alcohol, to observe their reactions in risky situations. Men aged 21-25 who frequently consume alcohol are ideal candidates for this trial. As an unphased trial, this study provides participants the opportunity to contribute to important research that could improve educational tools for preventing sexual violence.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that RealConsent2.0 is generally safe for participants. In studies, young adults found the program acceptable, indicating it is well-received and unlikely to cause harm. The program enhances understanding and skills related to sexual violence and alcohol use without major side effects.

For alcohol use, the study targets a breath alcohol concentration (BrAC) of .08. This level, considered legally intoxicated in many places, can affect judgment and memory, but the setting remains controlled. Participants receive close monitoring to ensure their safety.

Overall, based on the research, RealConsent2.0 and the associated alcohol use are considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RealConsent2.0 program because it offers a fresh approach to preventing sexual violence through an interactive, web-based format. Unlike traditional methods that often rely on in-person sessions or static materials, RealConsent2.0 uses revised multi-media content to engage participants, potentially making it more relatable and effective for today's digital-savvy audience. This program not only focuses on education but also empowers individuals with bystander intervention strategies, aiming to foster a proactive community response to sexual violence. Additionally, the study includes variations with and without alcohol intoxication to better understand how alcohol impacts the effectiveness of these interventions. By exploring these dynamics, researchers hope to gain insights that could lead to more effective prevention strategies.

What evidence suggests that this trial's treatments could be effective for preventing sexual violence?

Research has shown that the RealConsent2.0 program, one of the interventions in this trial, is designed to help young men make better choices in risky situations involving sexual violence. Early findings suggest that this program, which includes information about alcohol use, helps participants make smarter decisions even when drinking. In this trial, some participants will receive the RealConsent2.0 program with alcohol intoxication, while others will receive it with a no-alcohol placebo. Studies have found that alcohol often impairs people's ability to remember and understand these situations correctly. RealConsent2.0 uses a mix of online learning and virtual reality to teach men to act responsibly. This approach aims to increase their confidence and ability to step in and help when needed. ^{1 2 3 6 7}

Who Is on the Research Team?

Laura Salazar, Ph.D.

Principal Investigator

Georgia State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10717516/

Study protocol for a randomized controlled trial of ... RealConsent2.0 aims to facilitate bystander behavior among sober and intoxicated bystanders and uses a virtual reality (VR) environment to assess bystander ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04912492?tab=history&a=2

Record History | ver. 2: 2021-07-28 | NCT04912492 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 ...

3. withpower.com withpower.com/trial/realconsent20-for-preventing-sexual-violence-79778

RealConsent2.0 for Preventing Sexual Violence In a study involving 327 young adults, increased intoxication levels in bystanders were linked to poorer recall and risk assessment of sexual assault situations ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38087306/

a web-based intervention to promote prosocial alcohol ... Study protocol for a randomized controlled trial of RealConsent2.0: a web-based intervention to promote prosocial alcohol-involved bystander ...

5. researchgate.net researchgate.net/publication/376453308_Study_protocol_for_a_randomized_controlled_trial_of_RealConsent20_a_web-based_intervention_to_promote_prosocial_alcohol-involved_bystander_behavior_in_young_men

(PDF) Study protocol for a randomized controlled trial of ... Study protocol for a randomized controlled trial of RealConsent2.0: a web-based intervention to promote prosocial alcohol-involved bystander behavior in young ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10337467/

A Web-Based Sexual Violence, Alcohol Misuse, and ... The learning objectives of RealConsent were to (1) increase young women's awareness of the risks of alcohol use, (2) enhance the skills ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/10901981231208982

Acceptability of RealConsent: A Sexual Violence Web ... Results suggest that RealConsent is an acceptable SV risk reduction program among first-year female college students and may have advantages for ...