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

NCT05180539 | Completed Results

• 2 other identifiers: Interventional5R34AA026032
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

College Drinking

Outcome Measures

Primary Outcomes (6)

• 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

• 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 Outcomes (3)

• 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

Study Arms (2)

SPLASH Intervention Condition

EXPERIMENTAL

Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts

Behavioral: SPLASH Intervention Condition

Diet and Physical Activity Condition

OTHER

Two in-person group sessions addressing increasing healthy eating and physical activity

Behavioral: Control Condition

Interventions

SPLASH Intervention Condition BEHAVIORAL

Two-session in person group discussions focusing on behaviors in drinking contexts

SPLASH Intervention Condition

Control Condition BEHAVIORAL

Two-session in person group discussions focusing on college health behaviors

Diet and Physical Activity Condition

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be student at the site university

You may not qualify if:

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

Sponsors & Collaborators

• Lehigh University: lead
• Brown University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Lehigh University

Bethlehem, Pennsylvania, 18015, United States

Location

MeSH Terms

Conditions

Alcohol Drinking in College

Condition Hierarchy (Ancestors)

Alcohol Drinking; Drinking Behavior; Behavior

Limitations and Caveats

Trial was primarily designed to test feasibility and acceptability and not powered sufficiently to detect group differences.

Results Point of Contact

• Title: Lucy Napper
• Organization: Lehigh University

lun214@lehigh.edu

610 758 4689

Study Officials

• Lucy Napper, PhD

  Lehigh University

  PRINCIPAL INVESTIGATOR

• Shannon Kenney, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: January 6, 2022
• Study Start: September 23, 2021
• Primary Completion: May 8, 2022
• Study Completion: May 8, 2022
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)