Efficacy of a Web-based Sexual Violence Risk Reduction Program for Female College Students (RealConsent)
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|ClinicalTrials.gov Identifier: NCT03726437|
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : November 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sexual Violence||Behavioral: RealConsent Behavioral: Stress and Mood Management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||880 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Participants were told that study was to determine efficacy of a web-based health promotion program for female freshmen.|
|Official Title:||RealConsent: A Web-based Program to Reduce College Women's Risk of Sexual Violence by Targeting Alcohol Use, Communication and Consent, and Building Supportive Networks|
|Actual Study Start Date :||October 17, 2018|
|Actual Primary Completion Date :||November 1, 2019|
|Actual Study Completion Date :||November 1, 2019|
A 3-hour web-based program designed to teach female college freshmen strategies to reduce their risk of sexual violence victimization.
This 3-hour web-based program consists of four 45-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama ("Squad"), which allow for the modeling of positive behaviors and illustrate both positive and negative outcome expectations. Behaviors modeled include drinking safely (e.g., eating before drinking, pacing, and drinking water), having a game plan before going out, communicating with male sex partners, engaging in protective dating behaviors, use of resistance strategies, self-defense strategies and bystander intervention with the goal of reducing risk of being sexually assaulted.
Placebo Comparator: Stress and Mood Management
A 3-hour general mental health web-based program.
Behavioral: Stress and Mood Management
This 3-hour general health promotion web-based program consists of four 45-minute modules ("Stress Management", "Managing Depression", "Managing Anxiety", and "Treatments that work") that provide a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise.
- Sexual Violence Victimization [ Time Frame: 6 months ]Sexual Victimization will be assessed with the Sexual Experiences Survey— Short Form Victimization(SFV) (SES-SFV). The SES-SFV, a revision of the original 1982 Sexual Experiences Survey (SES), is the most widely used measure in sexual assault research and has high reliability and validity. Completed sexual assault (rape) will have occurred when a participant indicates she has had at least one experience of sexual intercourse (oral, anal, or vaginal) that was threatened, forced, or drugged (completed—not attempted). This will entail answering ' once' or more to any of 9 questions (involving oral sex, vaginal penetration, and/or anal penetration " without consent" when the woman was " too drunk or out of it to stop what was happening" , was threatened with physical harm to herself or others she cares about, and/or was forced, " for example holding me down with their body weight, pinning my arms, or having a weapon" ).
- Alcohol Protective Behaviors [ Time Frame: 6 months ]Alcohol protective behaviors (PBS) will be assessed with 15 items from the Protective Behavioral Strategies, with answer choices ranging on a 5-point scale (1) Always to (5) Never. Participants will be asked while using alcohol or "partying" whether they engaged in behaviors (e.g. "determine not to exceed a set number of drinks," "avoid mixing different types of alcohol," and "know where your drink had been at all times"). Items will be averaged for a total drinking PBS score.
- Sexual Assault Protective Behaviors [ Time Frame: 6 months ]Sexual assault protective behaviors will be assessed using a revised version of the Dating Self-Protection against Rape Scale, which consists of 15 items. Participants indicate how often they have engaged in behaviors (e.g., "provide your own transportation" and "meet in a public place instead of a private place") when they are with a date or with someone who is sexually interested in them. Answer choices range on a 5-point scale (1) Never to (5) Always.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726437
|United States, Georgia|
|Georgia State University|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Laura F. Salazar, PhD||Georgia State University|
|Study Director:||Anne Marie Schipani-McLaughlin, PhD||Georgia State University|
|Study Chair:||George Cavagnaro, MBA||Behavioral Science Technologies, LLC|