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Completed

NCT Number: NCT05180539

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

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.

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Key information

Conditions

College Drinking Alcohol Drinking Alcohol Drinking in College Behavior Drinking Behavior

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lehigh University

Bethlehem, Pennsylvania, 18015, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be student at the site university

Exclusion criteria

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

Treatment and study plan

SPLASH Intervention Condition

Behavioral

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

Control condition

Behavioral

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

Primary outcomes

  1. 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.

  2. 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)

  3. 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

  4. 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).

  5. 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.

  6. 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

  1. Alcohol and Sex Related Protective Behavioral Strategies Use

    Time frame: 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.

  2. Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form

    Time frame: 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

  3. Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire

    Time frame: Change from baseline to 6 month follow-up

    Respondents estimate the percent of same-campus peers who use alcohol before or during sex

Sponsors and collaborators

Lead sponsor

Lehigh University

Other

Collaborators

  • Brown University
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: SPLASH

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2022
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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