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

College Drinking Clinical Trial

— SPLASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05180539
• Other study ID #: Interventional
• Secondary ID: 5R34AA026032
• Status: Completed
• Phase: N/A
• Start date: September 23, 2021
• Est. completion date: May 8, 2022

Study information

• Verified date: August 2022
• Source: Lehigh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: May 8, 2022
• Est. primary completion date: May 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• Must be student at the site university

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Alcohol Drinking in College
• College Drinking

Intervention

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

Locations

Country	Name	City	State
United States	Lehigh University	Bethlehem	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Lehigh University	Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Program Satisfaction as assessed by the Acceptance Questionnaire	Satisfaction with the program content. Higher scores indicate more positive evaluations of the program content.	Immediate post intervention
Primary	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
Primary	Safe Sex	Frequency of alcohol use with sex and unprotected sex with casual partners	Change from baseline to 6 month follow-up
Primary	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
Primary	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	Alcohol and sex related protective behavioral strategies use	Self-reported frequency of using strategies to reduce alcohol risks and promote positive sexual experiences. Higher scores indicate more frequent use of protective strategies.	Change from baseline to 6 month follow-up
Secondary	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
Secondary	Perceived student sex norms as assessed by a Sex Norms Questionnaire	Respondents estimate the number of high-risk sex behaviors performed by other students on their campus in the past 30 days.	Change from baseline to 6 month follow-up