- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05892692
Nexus of Risk: Sexual Assault, Alcohol Use, and Risky Sex Among College Women
Nexus of Risk: Examining Sexual Assault, Alcohol Use, and Risky Sex Among College Women Through a Smartphone Application
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sexual assault is a significant public health problem. The sequelae of victimization involve both mental and physical health problems (Bedard-Gilligan et al., 2011; Hughes et al., 2010), and once victimized, women are at significant increased risk for revictimization (Classen et al., 2005; Messman-Moore & Long, 2003). Sexual assault has reached epidemic proportions on college campuses, with undergraduate women reporting high rates of victimization (Krebs et al., 2007). Alcohol use is intimately intertwined with sexual violence (Abbey, 2011), as well as high-risk sexual behavior (Scott-Sheldon et al., 2010). Work on the situational precipitants of sexual assault has relied primarily on women's retrospective accounts, even though autobiographical memory is plagued by error (Bradburn et al., 1987).
One way to obtain ecologically valid observations of these precipitants may be through Ecological Momentary Assessment (EMA). EMA data are collected in near realtime and are considered to have greater validity than retrospective accounts (Shiffman et al., 2008). The primary aim of this study will be to use EMA to obtain a better understanding of the contextual determinants of sexual assault, as well as the co-occurrence of victimization, risky sex, and substance use. This basic work then will inform the development of an Ecological Momentary Intervention (EMI) for college women to reduce their risk. EMI would permit an opportunity to intervene prior to and during high-risk situations by providing women with personalized feedback about their level of risk for victimization and related adverse events. The secondary aim of this study will be to conduct a randomized controlled trial (RCT) comparing the effectiveness of EMA/EMI, relative to EMA-only and an assessment only control group, in decreasing rates of sexual assault, risky sexual behavior, and substance use. This RCT will be prospective in design and target women who are at increased risk for assault (freshman). If supported, this work would offer college campuses a cost-effective, easily disseminated approach to preventing assault and other adverse consequences.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elizabeth Yeater, PhD
- Phone Number: (505) 277-0632
- Email: eyeater@unm.edu
Study Contact Backup
- Name: Katie Witkiewitz, PhD
- Phone Number: 505-277-4121
- Email: katiew@unm.edu
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- Logan Hall
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- (1) being between the ages of 18-24, as women younger than 25 are at highest risk for victimization (American Academy of Pediatrics, 2001); (2) being unmarried and interested in dating opposite sex partners, as the tasks given at baseline describe situations that unmarried, heterosexual, or bisexual college women might face when interacting socially with men; (3) being a binge drinker, defined by SAMHSA as having at least 4 drinks on one occasion in the past month, since drinking heavily (Testa et al., 2010) increases women's risk for victimization; (4) having engaged in sexual intercourse at least once, as these women will likely be at increased risk relative to non-sexually active women; and (5) being able to use a smartphone.
Exclusion Criteria:
- Participants who fail to meet all eligibility requirements listed above, or who report an AUDIT score greater than 16 or elevated mood symptoms are excluded from participating.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: EMA-only Condition
To examine situational precipitants of sexual assault, risky sexual behavior, and substance-use among freshman women (N=100) using EMA for 6 weeks.
To examine within- and between-persons factors that may influence the relationships among these situational precipitants and adverse consequences.
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Other: Focus Group
To gather preliminary research about the feasibility of an EMI sexual assault intervention prior to an experimental condition.
A small group of freshman women (N=20) will participate in an EMI protocol for six weeks, followed by providing feedback about their experience, including issues with phrasing, technical issues, and convenience.
|
Participants will receive hypothetical and real-time behavioral feedback using a smartphone application which provides ecological momentary responses to their current behaviors.
By providing safety tips and advice, the intervention may decrease incidences of sexual assault and risky sex compared to a control group.
|
Experimental: EMA/EMI Condition
To examine whether an EMA/EMI condition, relative to an EMA-only and a minimal assessment-only condition, decreases incidents of sexual assault, risky sexual behavior, and alcohol use among freshman women (N=288).
It is hypothesized that the 6-week EMA/EMI condition, relative to the other conditions, will be associated with lower rates of assault, risky sexual sex, and substance use from baseline to a 6-month followup.
|
Participants will receive hypothetical and real-time behavioral feedback using a smartphone application which provides ecological momentary responses to their current behaviors.
By providing safety tips and advice, the intervention may decrease incidences of sexual assault and risky sex compared to a control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Experiences Survey
Time Frame: Six Weeks
|
Measures victimization at a six month follow-up
|
Six Weeks
|
The Rutgers Alcohol Problem Index
Time Frame: Six Weeks
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The RAPI is a 23-item questionnaire developed specifically to evaluate alcohol-related problems of adolescents.
The measure has high internal consistency, with alpha = .92 in a sample of adolescents from 12 to 21.
|
Six Weeks
|
Sexual Risk Measure
Time Frame: Six Weeks
|
The SRM was developed by Consultant Bryan (Schmiege et al., 2009) and measures condom use, frequency of intercourse, and sexual behavior under the influence of alcohol.
A risky sex index is calculated such that higher scores indicate riskier sexual behavior.
|
Six Weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YeaterLab2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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