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

NCT ID: NCT03726437

Last Updated: 2023-02-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

881 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-17

Study Completion Date

2019-11-01

Brief Summary

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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").

Detailed Description

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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.

Conditions

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Sexual Violence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants were told that study was to determine efficacy of a web-based health promotion program for female freshmen.

Study Groups

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RealConsent

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

Group Type EXPERIMENTAL

RealConsent

Intervention Type 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.

Stress and Mood Management

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

Group Type PLACEBO_COMPARATOR

Stress and Mood Management

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Behavioral Science Technologies, LLC

INDUSTRY

Sponsor Role collaborator

Georgia State University

OTHER

Sponsor Role lead

Responsible Party

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Laura F Salazar

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura F. Salazar, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia State University

Anne Marie Schipani-McLaughlin, PhD

Role: STUDY_DIRECTOR

Georgia State University

George Cavagnaro, MBA

Role: STUDY_CHAIR

Behavioral Science Technologies, LLC

Locations

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Georgia State University

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37342080 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5R42AA025817-03

Identifier Type: NIH

Identifier Source: org_study_id

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