Clinical trial NCT03726437: Efficacy of a Web-based Sexual Violence Risk Reduction Program for Female College Students
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Violence
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Behavioral Science Technologies, LLC
First posted: 2018-10-31
Enrollment: 881
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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").

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Sexual Violence Victimization at 6-months Follow-up
timeFrame: Baseline to 6-months
Secondary outcomes:
measure: Change From Baseline in Alcohol Protective Behaviors at 6 Months
timeFrame: Baseline to 6 months
measure: Change From Baseline in Dating Risk Behaviors at 6-months Follow-up
timeFrame: Baseline to 6 months
measure: Change From Baseline in "Number of Times Engaged in Binge Drinking" to 6-months
timeFrame: Baseline to 6-months
measure: Change From Baseline in "Average Number of Alcoholic Drinks Per Occasion in Last 30 Days" to 6-months
timeFrame: baseline to 6-months
measure: Change From Baseline in Bystander Behavior at 6-months
timeFrame: Baseline to 6-months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Laura F. Salazar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgia State University
name: Anne Marie Schipani-McLaughlin, PhD
role: STUDY_DIRECTOR
affiliation: Behavioral Science Technologies, LLC
name: George Cavagnaro, MBA
role: STUDY_CHAIR
References: