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

Not Applicable

Completed

Conditions: College Drinking

Interventions: Behavioral: SPLASH Intervention Condition
Behavioral: Control Condition

Registration Number: NCT05180539

Lead Sponsor: Lehigh University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 274

Inclusion Criteria

Must be student at the site university

Exclusion Criteria

Students who have participated in relevant site specific studies will be excluded

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPLASH Intervention Condition	SPLASH Intervention Condition	-
Diet and Physical Activity Condition	Control Condition	-

Primary Outcome Measures

Name	Time	Method
Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Alcohol and Sex Related Protective Behavioral Strategies Use	Change from baseline to 6 month follow-up	Self-reported frequency of using strategies to reduce alcohol risks and promote positive sexual experiences \[unpublished measure\]. Higher scores indicate more frequent use of protective strategies. Scores range from 0 to 5 for both subscales.
Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form	Change from baseline to 6 month follow-up	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
Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire	Change from baseline to 6 month follow-up	Respondents estimate the percent of same-campus peers who use alcohol before or during sex