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Sexual ViolenceRealConsentNCT03726437

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

A study testing RealConsent and Stress and Mood Management in people with Sexual Violence, run by Georgia State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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"). Read more about this study

Who is it for?
Ages 18 to 20 years, women onlyHealthy volunteers can take part
Conditions the study is for
Sexual Violence
What is being tested?
RealConsent and Stress and Mood Management
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
881 participants
Where
1 siteUnited States
Study dates
17 Oct 2018to 1 Nov 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 20 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Georgia State University

    Atlanta, Georgia, 30303

Other trials in United States

About this study

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

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").

Read the 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.

Conditions
Sexual Violence
Being tested
RealConsent, Stress and Mood Management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RealConsentBehavioural

    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 ManagementBehavioural

    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.

Study groups in NCT03726437
Study groupRoleWhat they receive
RealConsentExperimentalA 3-hour web-based program designed to teach female college freshmen strategies to reduce their risk of sexual violence victimization.
Receives: Behavioral: RealConsent
Stress and Mood ManagementPlacebo comparatorA 3-hour general mental health web-based program.
Receives: Behavioral: Stress and Mood Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 6-months

Secondary outcomes (5)

  1. 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.

    Measured: Baseline to 6 months

  2. 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.

    Measured: Baseline to 6 months

  3. 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."

    Measured: Baseline to 6-months

  4. 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."

    Measured: baseline to 6-months

  5. 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.

    Measured: Baseline to 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2018
  2. Study start17 Oct 2018
  3. Primary completion1 Nov 2019
  4. Study completion1 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
881 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03726437
Sponsor's protocol ID
5R42AA025817-03
Acronym
RealConsent
Status last verified
Feb 2023
First submitted
29 Oct 2018
Last updated
13 Feb 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37342080

Questions about this trial

What is this clinical trial studying?

A study testing RealConsent and Stress and Mood Management in people with Sexual Violence, run by Georgia State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Sexual Violence Victimization at 6-months Follow-up (time frame: Baseline to 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03726437, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.

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