CClinicalTrials.gg
CompletedNCT05892692Updated Apr 2, 2024

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

An interventional study of Ecological Momentary Intervention in Sexual Assault, Substance Use and Risky Health Behavior, sponsored by University of New Mexico. Completed at 1 site in United States. Open to female participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-02.

Sponsored by University of New Mexico · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 7 months after the study started (first participant enrolled Oct 2018, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
183
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Sexual Assault
  • Substance Use
  • Risky Health Behavior
  • Ema

Keywords

  • Sexual Assault
  • Intervention
  • Ecological Momentary Assessment
  • Substance Use
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 183 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
183 participants (actual)

Study arms

  • 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.

  • 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.

    Behavioral: Ecological Momentary Intervention

  • 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.

    Behavioral: Ecological Momentary Intervention

Interventions

  • BehavioralEcological 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.

06

What researchers measure

Primary outcomes

  1. Sexual Experiences Survey

    Measures victimization at a six month follow-up

    Time frame: Six Weeks

  2. 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.

    Time frame: Six Weeks

  3. 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.

    Time frame: Six Weeks

07

Study locations

1 site
  • Logan Hall
    Albuquerque, New Mexico 87106, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05892692
Lead sponsor
University of New Mexico
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Elizabeth Yeater (Dr. Elizabeth Yeater, University of New Mexico) — Principal investigator
First posted
Jun 7, 2023
Start date
Oct 1, 2018
Primary completion
Dec 15, 2023
Completion
Dec 15, 2023
Last update
Apr 2, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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