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

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 Overview

• Status: Completed
• Conditions: College Drinking
• Intervention / Treatment: Behavioral: SPLASH Intervention Condition; Behavioral: Control Condition

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Lehigh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Must be student at the site university

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPLASH Intervention Condition; Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts	Behavioral: SPLASH Intervention Condition; Two-session in person group discussions focusing on behaviors in drinking contexts
Other: Diet and Physical Activity Condition; Two in-person group sessions addressing increasing healthy eating and physical activity	Behavioral: Control Condition; Two-session in person group discussions focusing on college health behaviors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session	Satisfaction with the program content after Session 1. Percent of participants reporting they were moderately-to-very satisfied with the program.	Immediate post intervention (same day as intervention), after first session on day 1
Program Satisfaction as Assessed by the Acceptance Questionnaire After Second Session	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)	Immediate post intervention (same day as intervention), after second session on ~Day 14
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
Alcohol Use Before or During Sex	Participants reported if they drank alcohol before or during sex in the past 30 days (code as yes = 1 or no = 0).	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 [unpublished measure]. Higher scores indicate more frequent use of protective strategies. Scores range from 0 to 5 for both subscales.	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 percent of same-campus peers who use alcohol before or during sex	Change from baseline to 6 month follow-up

Collaborators and Investigators

• Sponsor: Lehigh University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Brown University
• Investigators: Principal Investigator: Lucy Napper, PhD, Lehigh University; Principal Investigator: Shannon Kenney, PhD, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Actual): May 8, 2022
• Study Completion (Actual): May 8, 2022

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Alcohol Drinking in College
• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc); 5R34AA026032 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No