Efficacy of a Web-based Sexual Violence Risk Reduction Program for Female College Students

Sexual Violence Clinical Trial

— RealConsent  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726437
• Other study ID #: 5R42AA025817-03
• Status: Completed
• Phase: N/A
• Start date: October 17, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: February 2023
• Source: Georgia State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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").

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 881
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Sexual Violence

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Georgia State University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Georgia State University	Behavioral Science Technologies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Sexual Violence Victimization at 6-months Follow-up	Sexual assault victimization was assessed with Revised Sexual Experience Survey. Participants were asked how often they experienced 7 unwanted sexual experiences. Also, the tactic that was used ("using force") was also noted. Response options ranged from 0 (never) to 3 (3+times). An overall score for the SES, was calculated by summing each outcome and tactic score ("SOTS") with a range from 0 to 135- with higher scores indicating more sexual violence victimization. The 2nd method combines several of the outcomes, but keeps tactics separate, resulting in a potential range of 0 to 63.	Baseline to 6-months
Secondary	Change From Baseline in Alcohol Protective Behaviors at 6 Months	Alcohol protective behaviors was measured by a scale developed by Martens et al., 2005 that included 15 protective strategies (e.g.., "alternate alcoholic and non-alcoholic drinks") that asked participants if they had engaged in within the last 3 months. with response options of Never (1) to Always (5). Responses were summed across the 15 items. Potential range was 15 to 75. Higher scores indicated MORE protective strategies were used.	Baseline to 6 months
Secondary	Change From Baseline in Dating Risk Behaviors at 6-months Follow-up	Dating Risk Behaviors were measured by the Dating Behavior Survey created by Hanson & Gidycz, 1993. The scale consists of 15 items that assess different situational variables (e.g., "consuming alcohol on the first date") that have been found to be related to sexual violence victimization. Participants are asked to respond how often they have engaged in the behavior on the first few dates with a new partner. Response options ranged from Never (1) to Always (5). Scores are summed and higher scores indicate engaging in MORE risk behaviors. Overall scores can range from 15 to 75.	Baseline to 6 months
Secondary	Change From Baseline in "Number of Times Engaged in Binge Drinking" to 6-months	Participants were asked at baseline and at 6-month follow-up, to report: "In the past 30 days, the number of times four or more drinks were consumed in one setting."	Baseline to 6-months
Secondary	Change From Baseline in "Average Number of Alcoholic Drinks Per Occasion in Last 30 Days" to 6-months	Participants were asked at baseline and at 6-month follow-up to report, "the average number of alcoholic drinks consumed per occasion in the last 30 days."	baseline to 6-months
Secondary	Change From Baseline in Bystander Behavior at 6-months	Bystander behavior was assessed using the 20-item Bystander Behavior Scale. Items assessed whether participants engaged in bystander behaviors in the past three months and included items such as, "If I saw someone taking a very intoxicated person up to their room, I said something and asked what the friend was doing." Higher scores indicate a better outcome of engaging in more prosocial behaviors. Min value=0; Max value=60.	Baseline to 6-months