N/A
N=274
A Multi-Component Alcohol and Sex Risk Intervention for College Students
College Drinking
Bottom Line
View on ClinicalTrials.gov: NCT05180539 ↗Enrolled (actual)
274
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session — 86; 91 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SPLASH Intervention Condition (Behavioral); Control Condition (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lehigh University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session |
86; 91 | — |
| PRIMARY Program Satisfaction as Assessed by the Acceptance Questionnaire After Second Session |
83; 83 | — |
| PRIMARY Heavy Alcohol Use |
7.1; 5.6; 6.7; 5.3; 6.0; 4.7 | — |
| PRIMARY Alcohol Use Before or During Sex |
0.3; 0.3; 0.4; 0.4; 0.3; 0.3 | — |
| PRIMARY Bystander Behaviors Willingness Questionnaire |
6.0; 5.8; 5.1; 5.1; 6.0; 5.9 | — |
| PRIMARY Bystander Behaviors Self-efficacy Questionnaire |
4.1; 4.0; 4.0; 4.1; 4.1; 3.9 | — |
| SECONDARY Alcohol and Sex Related Protective Behavioral Strategies Use |
3.4; 3.4; 3.6; 3.3; 3.5; 3.5 | — |
| SECONDARY Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form |
13.1; 13.5; 10.1; 10.8; 10.4; 13.0 | — |
| SECONDARY Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire |
54.6; 56.0; 36.7; 52.9; 44.1; 54.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Must be student at the site university
Exclusion Criteria
- Students who have participated in relevant site specific studies will be excluded
Data sourced from ClinicalTrials.gov (NCT05180539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.