Sexual AssaultNCT05892692
Nexus of Risk: Sexual Assault, Alcohol Use, and Risky Sex Among College Women
A study testing Ecological Momentary Intervention in people with Sexual Assault and Substance Use, run by University of New Mexico at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Assault, Substance Use, Risky Health Behavior
- What is being tested?
- Ecological Momentary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- (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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nexus of Risk: Examining Sexual Assault, Alcohol Use, and Risky Sex Among College Women Through a Smartphone Application
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.
- Conditions
- Sexual Assault, Substance Use, Risky Health Behavior, Ema
- Being tested
- Ecological Momentary Intervention
- Keywords
- Sexual Assault, Intervention, Ecological Momentary Assessment, Substance Use
- Medical subject headings
- Substance-Related Disorders, Health Risk Behaviors, Multiple Acyl Coenzyme A Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological Momentary InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Ecological Momentary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Experiences Survey
Measures victimization at a six month follow-up
Measured: 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.
Measured: 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.
Measured: Six Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Oct 2018
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual AssaultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Elizabeth Yeater, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892692
- Sponsor's protocol ID
- YeaterLab2020
- Status last verified
- Apr 2024
- First submitted
- 26 May 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nexus of Risk: Examining Sexual Assault, Alcohol Use, and Risky Sex Among College Women Through a Smartphone Application
- ClinicalTrials.gov ID
- NCT05892692
- Acronym / sponsor ID
- YeaterLab2020
- Conditions
- Sexual Assault, Substance Use, Risky Health Behavior, Ema
- Keywords
- Sexual Assault, Intervention, Ecological Momentary Assessment, Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Ecological Momentary InterventionTo 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. |
| EMA/EMI Condition | Experimental | Behavioral: Ecological Momentary InterventionTo 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological Momentary InterventionParticipants 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. | Behavioural | EMA/EMI Condition, Focus Group |
Primary outcome
Sexual Experiences Survey
Time frame: Six Weeks
Measures victimization at a six month follow-up
The Rutgers Alcohol Problem Index
Time frame: Six Weeks
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Sexual Assault
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Study of Cross-Cutting E-Health Prevention Approaches
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Post-traumatic Estradiol Administration and Care Evaluation (PEACE)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological Momentary Intervention in people with Sexual Assault and Substance Use, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Experiences Survey (time frame: Six Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.