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NCT03726437: RealConsent

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

Completed NA Results posted Last updated 13 February 2023
What this trial tests

NA trial testing RealConsent in Sexual Violence in 881 participants. Completed in 1 November 2019.

Timeline
17 October 2018
Primary endpoint
1 November 2019
1 November 2019

Quick facts

Lead sponsorGeorgia State University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment881
Start date17 October 2018
Primary completion1 November 2019
Estimated completion1 November 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Georgia State University

Who can join

Adults 18 to 20, female only, with Sexual Violence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Sexual Violence Victimization at 6-months Follow-up Primary · Baseline to 6-months

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 score of "SOTS"
GroupValue95% CI
RealConsent5.64± 15.67
Stress and Mood Management5.68± 17.10
6-Month score of "SOTS"
GroupValue95% CI
RealConsent5.52± 18.4
Stress and Mood Management8.15± 25.36
Baseline score of "COSTS"
GroupValue95% CI
RealConsent3.69± 8.93
Stress and Mood Management3.78± 9.77
6-Month score of "COSTS"
GroupValue95% CI
RealConsent3.52± 10.55
Stress and Mood Management4.95± 13.63
Change From Baseline in Alcohol Protective Behaviors at 6 Months Secondary · Baseline to 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
GroupValue95% CI
RealConsent53.53± 12.17
Stress and Mood Management53.97± 11.35
6 months
GroupValue95% CI
RealConsent56.8± 11.7
Stress and Mood Management55.0± 11.6
Change From Baseline in Dating Risk Behaviors at 6-months Follow-up Secondary · Baseline to 6 months

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
GroupValue95% CI
RealConsent35.16± 5.11
Stress and Mood Management35.08± 4.80
6 months
GroupValue95% CI
RealConsent36.2± 7.3
Stress and Mood Management36.1± 5.7
Change From Baseline in "Number of Times Engaged in Binge Drinking" to 6-months Secondary · Baseline 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
GroupValue95% CI
RealConsent1.71± 2.53
Stress and Mood Management1.25± 1.8
6 months
GroupValue95% CI
RealConsent1.11± 1.8
Stress and Mood Management1.05± 1.8
Change From Baseline in "Average Number of Alcoholic Drinks Per Occasion in Last 30 Days" to 6-months Secondary · baseline 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
GroupValue95% CI
RealConsent1.64± 1.3
Stress and Mood Management1.45± 1.12
6 Months
GroupValue95% CI
RealConsent1.4± 1.2
Stress and Mood Management1.3± 1.3
Change From Baseline in Bystander Behavior at 6-months Secondary · Baseline to 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
GroupValue95% CI
RealConsent7.14± 9.02
Stress and Mood Management6.58± 9.03
6 Months
GroupValue95% CI
RealConsent6.03± 8.1
Stress and Mood Management7.6± 11.14

Sponsor's own description

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").

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Web-Based Sexual Violence, Alcohol Misuse, and Bystander Intervention Program for College Women (RealConsent): Randomized Controlled Trial.
    Salazar LF, Schipani-McLaughlin AM, Sebeh Y, Nizam Z, et al · · 2023 · cited 15× · PMID 37342080 · DOI 10.2196/43740

Verify or expand the search:

Other recruiting trials for Sexual Violence

Currently open trials in the same condition.

Other Georgia State University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03726437.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing