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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
Sponsor:
Collaborator:
Behavioral Science Technologies, LLC
Information provided by (Responsible Party):
Laura F Salazar, Georgia State University

Brief Summary:
This study evaluates the efficacy of a web-based program for female college freshmen ("RealConsent") in reducing their risk of sexual violence victimization. Half the participants will receive RealConsent-F and half will receive an attention-placebo control ("Stress and Mood Management").

Condition or disease Intervention/treatment Phase
Sexual Violence Behavioral: RealConsent Behavioral: Stress and Mood Management Not Applicable

Detailed Description:
Sexual assault of college women is a serious and complex public health problem: one in five college women report being sexually assaulted. The purpose of this study is to conduct a randomized controlled trial study with 750 female college students from three universities to test the efficacy of RealConsent, a sexual violence risk reduction program for college women, compared to an attention-placebo control. RealConsent is a multi-media 3-hour program based on social cognitive theory and alcohol myopia theory. The primary outcome will be self-reported sexual violence victimization and the secondary outcomes will be alcohol and dating protective- and risk-related behaviors and resistance strategies. The investigators expect that women in the treatment group will report less sexual violence victimization than women in the control group. Expected outcomes are demonstrated feasibility and efficacy of a technologically novel risk reduction program for female college students.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 880 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: RealConsent
A 3-hour web-based program designed to teach female college freshmen strategies to reduce their risk of sexual violence victimization.
Behavioral: RealConsent
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.




Primary Outcome Measures :
  1. 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" ).


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 20 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female, aged 18-20 years, full-time freshmen, matriculated at Georgia State University, Emory University, or University of Georgia, and single (i.e., not in a committed dating relationship).

Exclusion Criteria:

  • other education levels, married, and/or graduate status

Information from the National Library of Medicine

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


Locations
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United States, Georgia
Georgia State University
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Georgia State University
Behavioral Science Technologies, LLC
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Laura F Salazar, Georgia State University:
Informed Consent Form  [PDF] July 31, 2018


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Responsible Party: Laura F Salazar, Professor, Georgia State University
ClinicalTrials.gov Identifier: NCT03726437     History of Changes
Other Study ID Numbers: 5R42AA025817-03 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data from approximately 750 female freshmen participating in this study will be made available. The final dataset will include self-reported sexual violence victimization experiences, risk behaviors and scale measures of secondary outcomes.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: The study principal investigator will review all data requests. Requestors will be required to sign a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No