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

Sponsor
Lehigh University (Other)
Overall Status
Completed
CT.gov ID
NCT05180539
Collaborator
Brown University (Other), National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
217
1
2
7.5
29.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SPLASH Intervention Condition
  • Behavioral: Control Condition
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
217 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
A Multi-Component Alcohol and Sex Risk Intervention for College Students
Actual Study Start Date :
Sep 23, 2021
Actual Primary Completion Date :
May 8, 2022
Actual Study Completion Date :
May 8, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: SPLASH Intervention Condition

Behavioral: SPLASH Intervention Condition
Two-session in person group discussions focusing on behaviors in drinking contexts

Other: Diet and Physical Activity Condition

Behavioral: Control Condition
Two-session in person group discussions focusing on college health behaviors

Outcome Measures

Primary Outcome Measures

  1. Program Satisfaction as assessed by the Acceptance Questionnaire [Immediate post intervention]

    Satisfaction with the program content. Higher scores indicate more positive evaluations of the program content.

  2. 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

  3. Safe Sex [Change from baseline to 6 month follow-up]

    Frequency of alcohol use with sex and unprotected sex with casual partners

  4. 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.

  5. 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

  1. 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. Higher scores indicate more frequent use of protective strategies.

  2. 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

  3. Perceived student sex norms as assessed by a Sex Norms Questionnaire [Change from baseline to 6 month follow-up]

    Respondents estimate the number of high-risk sex behaviors performed by other students on their campus in the past 30 days.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Must be student at the site university
Exclusion Criteria:
  • Students who have participated in relevant site specific studies will be excluded

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lehigh University Bethlehem Pennsylvania United States 18015

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lehigh University
ClinicalTrials.gov Identifier:
NCT05180539
Other Study ID Numbers:
  • Interventional
  • 5R34AA026032
First Posted:
Jan 6, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022