Nexus of Risk: Sexual Assault, Alcohol Use, and Risky Sex Among College Women

Substance Use Clinical Trial

Official title:

Nexus of Risk: Examining Sexual Assault, Alcohol Use, and Risky Sex Among College Women Through a Smartphone Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05892692
• Other study ID #: YeaterLab2020
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 15, 2023

Study information

• Verified date: April 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sexual assault on college campuses has reached epidemic proportions, yet the etiological variables responsible for violence against women in these contexts remain unclear. Work on the situational precipitants of sexual assault has relied primarily on women's retrospective accounts, but research has shown that autobiographical memory is plagued by error. This study will use Ecological Momentary Assessment (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. These findings will inform the development of an Ecological Momentary Intervention (EMI) that will provide college women with personalized feedback about their level of risk for victimization and related adverse events. The effectiveness of EMA/EMI in decreasing rates of sexual assault, risky sexual behavior, and substance use then will be evaluated relative to an EMA-only and an assessment-only control group.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Risky Health Behavior
• Sexual Assault
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Ecological Momentary Intervention
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.

Locations

Country	Name	City	State
United States	Logan Hall	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Experiences Survey	Measures victimization at a six month follow-up	Six Weeks
Primary	The Rutgers Alcohol Problem Index	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
Primary	Sexual Risk Measure	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