search
Back to results

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

Primary Purpose

College Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPLASH Intervention Condition
Control Condition
Sponsored by
Lehigh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for College Drinking

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Must be student at the site university

Exclusion Criteria:

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

Sites / Locations

  • Lehigh University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

SPLASH Intervention Condition

Diet and Physical Activity Condition

Arm Description

Outcomes

Primary Outcome Measures

Program Satisfaction as assessed by the Acceptance Questionnaire
Satisfaction with the program content. Higher scores indicate more positive evaluations of the program content.
Heavy alcohol use
Number of standard drinks consumed in a typical week over the past 30 days
Safe Sex
Frequency of alcohol use with sex and unprotected sex with casual partners
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.
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.

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
September 9, 2021
Last Updated
August 16, 2022
Sponsor
Lehigh University
Collaborators
Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05180539
Brief Title
A Multi-Component Alcohol and Sex Risk Intervention for College Students
Acronym
SPLASH
Official Title
A Multi-Component Alcohol and Sex Risk Intervention for College Students
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
May 8, 2022 (Actual)
Study Completion Date
May 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lehigh University
Collaborators
Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
College Drinking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPLASH Intervention Condition
Arm Type
Experimental
Arm Title
Diet and Physical Activity Condition
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
SPLASH Intervention Condition
Intervention Description
Two-session in person group discussions focusing on behaviors in drinking contexts
Intervention Type
Behavioral
Intervention Name(s)
Control Condition
Intervention Description
Two-session in person group discussions focusing on college health behaviors
Primary Outcome Measure Information:
Title
Program Satisfaction as assessed by the Acceptance Questionnaire
Description
Satisfaction with the program content. Higher scores indicate more positive evaluations of the program content.
Time Frame
Immediate post intervention
Title
Heavy alcohol use
Description
Number of standard drinks consumed in a typical week over the past 30 days
Time Frame
Change from baseline to 6 month follow-up
Title
Safe Sex
Description
Frequency of alcohol use with sex and unprotected sex with casual partners
Time Frame
Change from baseline to 6 month follow-up
Title
Bystander Behaviors Willingness Questionnaire
Description
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.
Time Frame
Change from baseline to 6 month follow-up
Title
Bystander Behaviors Self-efficacy Questionnaire
Description
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.
Time Frame
Change from baseline to 6 month follow-up
Secondary Outcome Measure Information:
Title
Alcohol and sex related protective behavioral strategies use
Description
Self-reported frequency of using strategies to reduce alcohol risks and promote positive sexual experiences. Higher scores indicate more frequent use of protective strategies.
Time Frame
Change from baseline to 6 month follow-up
Title
Perceived student drinking norms as assessed by the Drinking Norms Rating Form
Description
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
Time Frame
Change from baseline to 6 month follow-up
Title
Perceived student sex norms as assessed by a Sex Norms Questionnaire
Description
Respondents estimate the number of high-risk sex behaviors performed by other students on their campus in the past 30 days.
Time Frame
Change from baseline to 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must be student at the site university Exclusion Criteria: Students who have participated in relevant site specific studies will be excluded
Facility Information:
Facility Name
Lehigh University
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs