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

NCT03726437 | Completed Results DMC

• 1 other identifier: 5R42AA025817-03
• Study Type: interventional
• Target: 881
• Locations: 1 country
• Sites: 1

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").

Conditions

Sexual Violence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change From Baseline in Alcohol Protective Behaviors at 6 Months

  Baseline to 6 months

• Change From Baseline in Dating Risk Behaviors at 6-months Follow-up

  Baseline to 6 months

• Change From Baseline in "Number of Times Engaged in Binge Drinking" to 6-months

  Baseline to 6-months

• Change From Baseline in "Average Number of Alcoholic Drinks Per Occasion in Last 30 Days" to 6-months

  baseline to 6-months

• Change From Baseline in Bystander Behavior at 6-months

  Baseline to 6-months

Study Arms (2)

RealConsent

EXPERIMENTAL

A 3-hour web-based program designed to teach female college freshmen strategies to reduce their risk of sexual violence victimization.

Behavioral: RealConsent

Stress and Mood Management

PLACEBO COMPARATOR

A 3-hour general mental health web-based program.

Behavioral: Stress and Mood Management

Interventions

RealConsent BEHAVIORAL

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.

RealConsent

Stress and Mood Management BEHAVIORAL

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.

Stress and Mood Management

Eligibility Criteria

• Age: 18 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Georgia State University: lead
• Behavioral Science Technologies, LLC: collaborator

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

• Salazar LF, Schipani-McLaughlin AM, Sebeh Y, Nizam Z, Hayat M. A Web-Based Sexual Violence, Alcohol Misuse, and Bystander Intervention Program for College Women (RealConsent): Randomized Controlled Trial. J Med Internet Res. 2023 Jun 21;25:e43740. doi: 10.2196/43740.

  PMID: 37342080 DERIVED

Results Point of Contact

• Title: Dr. Laura Salazar
• Organization: GEORGIA STATE UNIVERSITY

lsalazar1@gsu.edu

4044131396

Study Officials

• Laura F. Salazar, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

• Anne Marie Schipani-McLaughlin, PhD

  Georgia State University

  STUDY DIRECTOR

• George Cavagnaro, MBA

  Behavioral Science Technologies, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were told that study was to determine efficacy of a web-based health promotion program for female freshmen.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 31, 2018
• Study Start: October 17, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: February 13, 2023
• Results First Posted: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)