College DrinkingSPLASHNCT05180539

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

A study testing SPLASH Intervention Condition in people with College Drinking, run by Lehigh University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for: College Drinking
What is being tested?: SPLASH Intervention Condition
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 274 participants
Where: 1 siteUnited States
Study dates: 23 Sep 2021to 8 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 24 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Must be student at the site university

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Lehigh University
Bethlehem, Pennsylvania, 18015

Other trials in United States

About this study

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.

Conditions: College Drinking
Being tested: SPLASH Intervention Condition, Control Condition
Medical subject headings: Alcohol Drinking in College

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SPLASH Intervention ConditionBehavioural
Two-session in person group discussions focusing on behaviors in drinking contexts
Control ConditionBehavioural
Two-session in person group discussions focusing on college health behaviors

Study groups in NCT05180539
Study group	Role	What they receive
SPLASH Intervention Condition	Experimental	Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts Receives: Behavioral: SPLASH Intervention Condition
Diet and Physical Activity Condition	Other	Two in-person group sessions addressing increasing healthy eating and physical activity Receives: Behavioral: Control Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session
Satisfaction with the program content after Session 1. Percent of participants reporting they were moderately-to-very satisfied with the program.
Measured: Immediate post intervention (same day as intervention), after first session on day 1
Program Satisfaction as Assessed by the Acceptance Questionnaire After Second Session
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)
Measured: Immediate post intervention (same day as intervention), after second session on ~Day 14
Heavy Alcohol Use
Number of standard drinks consumed in a typical week over the past 30 days
Measured: Change from baseline to 6 month follow-up
Alcohol Use Before or During Sex
Participants reported if they drank alcohol before or during sex in the past 30 days (code as yes = 1 or no = 0).
Measured: Change from baseline to 6 month follow-up
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.
Measured: Change from baseline to 6 month follow-up
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.
Measured: Change from baseline to 6 month follow-up

Secondary outcomes (3)

Alcohol and Sex Related Protective Behavioral Strategies Use
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.
Measured: Change from baseline to 6 month follow-up
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
Measured: Change from baseline to 6 month follow-up
Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire
Respondents estimate the percent of same-campus peers who use alcohol before or during sex
Measured: Change from baseline to 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 20218 May 2022

First posted6 Jan 2022
Study start23 Sep 2021
Primary completion8 May 2022
Study completion8 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for College DrinkingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 274 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05180539
Sponsor's protocol ID: Interventional
Other IDs: 5R34AA026032
Acronym: SPLASH
Status last verified: Apr 2025
First submitted: 9 Sep 2021
Last updated: 30 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Component Alcohol and Sex Risk Intervention for College Students
ClinicalTrials.gov ID: NCT05180539
Acronym / sponsor ID: SPLASH / Interventional
Conditions: College Drinking
Study type: Interventional
Recruitment status: Completed
Enrolment: 274 participants (actual)
Lead sponsor: Lehigh UniversityUniversity, hospital or other
Collaborators: Brown University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 23 Sep 2021 (actual)
Primary completion: 8 May 2022 (actual)
Study completion: 8 May 2022 (actual)
First posted: 6 Jan 2022 (actual)
Results: Posted 30 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
SPLASH Intervention Condition	Experimental	Behavioral: SPLASH Intervention ConditionTwo in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts
Diet and Physical Activity Condition	Other	Behavioral: Control ConditionTwo in-person group sessions addressing increasing healthy eating and physical activity

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Must be student at the site university

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SPLASH Intervention ConditionTwo-session in person group discussions focusing on behaviors in drinking contexts	Behavioural	SPLASH Intervention Condition
Control ConditionTwo-session in person group discussions focusing on college health behaviors	Behavioural	Diet and Physical Activity Condition

Primary outcome

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.
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)
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
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).
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.
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.

3 secondary outcomes

Alcohol and Sex Related Protective Behavioral Strategies Use
Time frame: 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 Student Sex Norms as Assessed by a Sex Norms Questionnaire
Time frame: Change from baseline to 6 month follow-up

Results and safety

Results posted to the registry on 30 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SPLASH Intervention Condition	134	107
Diet and Physical Activity Condition	140	110

Primary outcome: 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. Count of participants. Unit: Participants

Measure	SPLASH Intervention Condition n = 99
Overall Satisfaction (after Session 1)	86
Would recommend program to friend (after Session 1)	91

Population analysed: Program satisfaction not examined in control condition (diet and physical activity group). Missing data reflects the study design. Participants could attend 1 or 2 study sessions. Data is missing for participants who did not attend the first in-person session (follow-up data was still collected for these participants).

Primary outcome: 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. Count of participants. Unit: Participants

Measure	SPLASH Intervention Condition n = 87
Overall Satisfaction (After Session 2 [~ Day 14)	83
Would recommend program to friend (After Session 2) [~ Day 14)	83

Population analysed: Program satisfaction not examined in control condition (diet and physical activity group). Missing data reflects the study design. Participants could attend 1 or 2 study sessions. Data is missing for participants who did not attend the second in-person session (follow-up data was still collected for these participants).

Primary outcome: Heavy Alcohol Use

Time frame: Change from baseline to 6 month follow-up. Mean (Standard Error). Unit: Drinks per week

Measure	SPLASH Intervention Condition n = 106	Diet and Physical Activity Condition n = 109
Baseline	7.1 (0.8)	5.6 (0.7)
1 month	6.7 (0.7)	5.3 (0.6)
6 months	6.0 (0.7)	4.7 (0.6)

Population analysed: Participants who did not complete the 1 month follow up survey were still able to complete the 6 month follow up survey. The analysis sample reflects participants who completed the baseline survey, attended at least 1 in-person group meeting, and completed at least one follow up survey (1 month or 6 month). Adjusted means are reported from a Generalized Estimating Equations (GEE) model that accounts for missing data if participants missed a follow-up survey.

Primary outcome: Alcohol Use Before or During Sex

Time frame: Change from baseline to 6 month follow-up. Number. Unit: adjusted percentage of participants

Measure	SPLASH Intervention Condition n = 107	Diet and Physical Activity Condition n = 110
Baseline	0.3	0.3
1 month	0.4	0.4
6 months	0.3	0.3

Population analysed: Participants who did not complete the 1 month follow up survey were still able to complete the 6 month follow up survey. The analysis sample reflects participants who completed the baseline survey, attended at least 1 in-person group meeting, and completed at least one follow up survey (1 month or 6 month). Adjusted proportions are reported from a GEE model that accounts for missing data if participants missed a follow-up survey.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SPLASH Intervention Condition	0 of 107 (0%)	0 of 107 (0%)	0 of 107
Diet and Physical Activity Condition	0 of 110 (0%)	0 of 110 (0%)	0 of 110

Limitations and caveats (from the sponsor): Trial was primarily designed to test feasibility and acceptability and not powered sufficiently to detect group differences.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lucy Napper, PhD principal investigator

Lehigh University

Shannon Kenney, PhD principal investigator

Brown University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SPLASH Intervention Condition in people with College Drinking, run by Lehigh University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05180539.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.