- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05180539
A Multi-Component Alcohol and Sex Risk Intervention for College Students (SPLASH)
August 16, 2022 updated by: Lehigh University
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
217
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, United States, 18015
- Lehigh University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SPLASH Intervention Condition
|
Two-session in person group discussions focusing on behaviors in drinking contexts
|
Other: Diet and Physical Activity 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 |
---|---|---|
Program Satisfaction as assessed by the Acceptance Questionnaire
Time Frame: Immediate post intervention
|
Satisfaction with the program content.
Higher scores indicate more positive evaluations of the program content.
|
Immediate post intervention
|
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
|
Change from baseline to 6 month follow-up
|
Safe Sex
Time Frame: Change from baseline to 6 month follow-up
|
Frequency of alcohol use with sex and unprotected sex with casual partners
|
Change from baseline to 6 month follow-up
|
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.
|
Change from baseline to 6 month follow-up
|
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.
|
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
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.
Higher scores indicate more frequent use of protective strategies.
|
Change from baseline to 6 month follow-up
|
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
|
Change from baseline to 6 month follow-up
|
Perceived student sex norms as assessed by a Sex Norms Questionnaire
Time Frame: 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.
|
Change from baseline to 6 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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)
August 17, 2022
Last Update Submitted That Met QC Criteria
August 16, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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