NCT05892692

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

5.2 years

First QC Date

May 26, 2023

Last Update Submit

April 1, 2024

Conditions

Keywords

Sexual AssaultInterventionEcological Momentary AssessmentSubstance Use

Outcome Measures

Primary Outcomes (3)

  • Sexual Experiences Survey

    Measures victimization at a six month follow-up

    Six Weeks

  • 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

  • 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

Study Arms (3)

EMA-only Condition

NO INTERVENTION

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.

Focus Group

OTHER

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

EMA/EMI Condition

EXPERIMENTAL

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

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.

EMA/EMI ConditionFocus Group

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsTransgender women who are interested in dating men were included in gathering data.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Logan Hall

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersHealth Risk BehaviorsMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersHealth BehaviorBehaviorAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMitochondrial Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Participants in the EMA/EMI condition will complete EMA as specified in Study 1. In addition, they will receive a personalized intervention regarding their level of risk during EMA. The EMI content will include three types of targeted feedback intervention options that will be provided to participants in near real-time after random and event-contingent reports based on tailoring variables (i.e., predictors of risk taking, assault, and substance use) identified during Study 1. Participants will be given feedback about their drinking, drug use, and safe-sex practices, as well as their performance on risk judgment and response-selection tasks at baseline. They will receive behavioral comparisons to the average UNM undergraduate woman, and will be provided strategies for reducing risk for sexual assault, negative consequences of substance use, and STIs.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Elizabeth Yeater

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 7, 2023

Study Start

October 1, 2018

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

April 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations