NCT04016766

Brief Summary

The primary objective of the research study is to develop and test a prepartying (aka "pregaming") specific brief mobile app intervention that is intended to help college students reduce their prepartying drinking behavior. Such behavior has been identified as a major contributor to alcohol-related negative consequences among young people. The investigators will first develop the intervention content based on theory and research supporting mechanisms of change in brief interventions with college students and document normative drinking information from 500 college students for inclusion in the intervention content. Investigators will then beta test the intervention with a sample of 14 heavy drinking college students. Focus group feasibility and acceptability feedback will inform the final intervention content. Investigators will then pilot test the mobile-based intervention in a randomized controlled trial of 500 college students who preparty frequently (n = 250 intervention, n = 250 attention control) and determine the efficacy of the intervention on (1) preventing heavy consumption levels during and after prepartying and on (2) reducing students' global levels of heavy drinking and consequences one and three months post-intervention.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
2.1 years until next milestone

Study Start

First participant enrolled

August 9, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

July 10, 2019

Last Update Submit

August 15, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • Prepartying frequency

    Number of days reported prepartying on the timeline followback

    Past month (30 days)

  • Drinks during prepartying

    Average number of drinks reported during prepartying on the timeline followback

    Past month (30 days)

  • Drinking frequency

    Number of days reported any drinking on the timeline followback

    Past month (30 days)

  • Drinks on drinking days

    Average number of drinks reported during drinking days on the timeline followback

    Past month (30 days)

  • 21-item Brief Young Adult Alcohol Consequences Questionnaire

    Number of 21 assessed alcohol consequences experienced (yes/no). Yes responses are summed to yield a score on this measure. Higher scores indicate experience of a greater number of consequences. Scores range from 0 (no consequences) to 21 (experience of all 21 consequences)

    Past month (30 days)

Study Arms (2)

Prepartying mobile app intervention

EXPERIMENTAL

Mobile app intervention

Behavioral: Mobile app prepartying intervention

Control

NO INTERVENTION

Control participants receive a personalized attention control task (i.e., listing and ranking favorite movies, music, and books), which controls for the time needed by the intervention group to view the intervention material.

Interventions

The intervention is comprised of a theoretically-informed and empirically-supported, brief, accessible, and personalized intervention to address prepartying drinking. the prepartying intervention app will be tailored toward an individual's personal goals, beliefs (perceptions, expectancies, self-efficacy), and behavior (protective strategies), and focus on the core components of brief interventions that have been cited as constructs that mediate the effects of multiple component intervention programs (e.g., correcting perceived norms, use of protective behavioral strategies, increased self-efficacy, challenging expectancies, feedback on blood alcohol level).

Prepartying mobile app intervention

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • full time undergraduate college student
  • between the ages of 18 and 24
  • report typically prepartying at least once per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

RECRUITING

Related Publications (2)

  • Pedersen ER, Hummer JF, Davis JP, Fitzke RE, Tran DD, Witkiewitz K, Clapp JD. A mobile-based pregaming drinking prevention intervention for college students: A pilot randomized controlled trial. Psychol Addict Behav. 2023 Nov;37(7):841-852. doi: 10.1037/adb0000925. Epub 2023 Apr 13.

  • Pedersen ER, Hummer JF, Davis JP, Fitzke RE, Christie NC, Witkiewitz K, Clapp JD. A mobile-based pregaming drinking prevention intervention for college students: study protocol for a randomized controlled trial. Addict Sci Clin Pract. 2022 Jun 18;17(1):31. doi: 10.1186/s13722-022-00314-5.

Central Study Contacts

Eric R Pedersen

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 11, 2019

Study Start

August 9, 2021

Primary Completion

May 31, 2022

Study Completion

August 31, 2022

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations