A Multi-Component Alcohol and Sex Risk Intervention for College Students
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lehigh University
- Enrollment
- 274
- Locations
- 2
- Primary Endpoint
- Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 24 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Must be student at the site university
Exclusion Criteria
- •Students who have participated in relevant site specific studies will be excluded
Outcomes
Primary Outcomes
Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session
Time Frame: Immediate post intervention (same day as intervention), after first session on day 1
Satisfaction with the program content after Session 1. Percent of participants reporting they were moderately-to-very satisfied with the program.
Program Satisfaction as Assessed by the Acceptance Questionnaire After Second Session
Time Frame: Immediate post intervention (same day as intervention), after second session on ~Day 14
Satisfaction with the program content after session 2. Percent of participants reporting that they were moderately-to-very satisfied with the program. For participants who did not attend the first session this occurred on Day 1. For Participants who did attend the first session this occurred around Day 14 (range between day 12 and 17)
Heavy Alcohol Use
Time Frame: Change from baseline to 6 month follow-up
Number of standard drinks consumed in a typical week over the past 30 days
Alcohol Use Before or During Sex
Time Frame: Change from baseline to 6 month follow-up
Participants reported if they drank alcohol before or during sex in the past 30 days (code as yes = 1 or no = 0).
Bystander Behaviors Willingness Questionnaire
Time Frame: Change from baseline to 6 month follow-up
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.
Bystander Behaviors Self-efficacy Questionnaire
Time Frame: Change from baseline to 6 month follow-up
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.
Secondary Outcomes
- Alcohol and Sex Related Protective Behavioral Strategies Use(Change from baseline to 6 month follow-up)
- Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form(Change from baseline to 6 month follow-up)
- Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire(Change from baseline to 6 month follow-up)