A Multi-Component Alcohol and Sex Risk Intervention for College Students

Study Overview
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Brief Summary
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Hazardous alcohol use, sexually transmitted infections, and sexual violence are interrelated and highly prevalent public health concerns in college student populations. The current study seeks to develop a tri-pronged sex-positive intervention that addresses risky alcohol use, unsafe sex, and sexual violence for college men and women (ages 18-24). The study involves a small randomized pilot trial to demonstrate the feasibility and acceptability of the recruitment methods and research design. Preliminary evidence of intervention efficacy will also be evaluated.

Official Title
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A Multi-Component Alcohol and Sex Risk Intervention for College Students

Conditions
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College Drinking

Intervention / Treatment
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* Behavioral: SPLASH Intervention Condition
* Behavioral: Control Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be student at the site university Exclusion Criteria: Students who have participated in relevant site specific studies will be excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPLASH Intervention Condition<br> | Behavioral: SPLASH Intervention Condition<br>* Two-session in person group discussions focusing on behaviors in drinking contexts<br>|
| Other: Diet and Physical Activity Condition<br> | Behavioral: Control Condition<br>* Two-session in person group discussions focusing on college health behaviors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program Satisfaction as assessed by the Acceptance Questionnaire | Satisfaction with the program content. Higher scores indicate more positive evaluations of the program content. | Immediate post intervention | 
| Heavy alcohol use | Number of standard drinks consumed in a typical week over the past 30 days | Change from baseline to 6 month follow-up | 
| Safe Sex | Frequency of alcohol use with sex and unprotected sex with casual partners | Change from baseline to 6 month follow-up | 
| Bystander Behaviors Willingness Questionnaire | Willingness to engage in bystander behaviors. Mean scale scores range from 1 to 7. Higher scores indicate more greater willingness to engage in bystander behaviors. | Change from baseline to 6 month follow-up | 
| Bystander Behaviors Self-efficacy Questionnaire | Confidence to engage in bystander behaviors. Higher scores indicate more greater confidence in ability to engage in bystander behaviors. Mean scale scores range from 1 to 5. | Change from baseline to 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol and sex related protective behavioral strategies use | Self-reported frequency of using strategies to reduce alcohol risks and promote positive sexual experiences. Higher scores indicate more frequent use of protective strategies. | Change from baseline to 6 month follow-up | 
| Perceived student drinking norms as assessed by the Drinking Norms Rating Form | Perceived descriptive norms are assessed using a variation on the Drinking Norms Rating Form. Respondents estimate the number of standard drinks consumed by other students on their campus for each day in a typical week in the past 30 days; daily estimates are summed to yield perceived number of drinks per week for student peers; range of scores can go from zero to no upper limit | Change from baseline to 6 month follow-up | 
| Perceived student sex norms as assessed by a Sex Norms Questionnaire | Respondents estimate the number of high-risk sex behaviors performed by other students on their campus in the past 30 days. | Change from baseline to 6 month follow-up |