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

NCT ID: NCT05180539

Last Updated: 2025-04-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-23

Study Completion Date

2022-05-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

College Drinking

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SPLASH Intervention Condition

Two in-person group sessions addressing alcohol harm reduction and intervening to reduce sexual violence in drinking contexts

Group Type EXPERIMENTAL

SPLASH Intervention Condition

Intervention Type BEHAVIORAL

Two-session in person group discussions focusing on behaviors in drinking contexts

Diet and Physical Activity Condition

Two in-person group sessions addressing increasing healthy eating and physical activity

Group Type OTHER

Control Condition

Intervention Type BEHAVIORAL

Two-session in person group discussions focusing on college health behaviors

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SPLASH Intervention Condition

Two-session in person group discussions focusing on behaviors in drinking contexts

Intervention Type BEHAVIORAL

Control Condition

Two-session in person group discussions focusing on college health behaviors

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Must be student at the site university

Exclusion Criteria

* Students who have participated in relevant site specific studies will be excluded
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brown University

OTHER

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Lehigh University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lucy Napper, PhD

Role: PRINCIPAL_INVESTIGATOR

Lehigh University

Shannon Kenney, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lehigh University

Bethlehem, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5R34AA026032

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Interventional

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Multi-Component Breath Alcohol Intervention
NCT06124898 ACTIVE_NOT_RECRUITING NA
Alcohol Use and Relationships - III
NCT01753986 UNKNOWN PHASE2
Substance Use in Assault-Injured Young Adults
NCT07070414 NOT_YET_RECRUITING NA