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Brief Mobile Intervention for Prepartying

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ClinicalTrials.gov Identifier: NCT04016766
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
RAND

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.

Condition or disease Intervention/treatment Phase
Heavy Drinking Behavioral: Mobile app prepartying intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mobile Application Intervention Targeting the High Risk Drinking Practice of Prepartying
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : August 31, 2021

Arm Intervention/treatment
Experimental: Prepartying mobile app intervention
Mobile app intervention
Behavioral: Mobile app prepartying intervention
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).

No Intervention: Control
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.



Primary Outcome Measures :
  1. Prepartying frequency [ Time Frame: Past month (30 days) ]
    Number of days reported prepartying on the timeline followback

  2. Drinks during prepartying [ Time Frame: Past month (30 days) ]
    Average number of drinks reported during prepartying on the timeline followback

  3. Drinking frequency [ Time Frame: Past month (30 days) ]
    Number of days reported any drinking on the timeline followback

  4. Drinks on drinking days [ Time Frame: Past month (30 days) ]
    Average number of drinks reported during drinking days on the timeline followback

  5. 21-item Brief Young Adult Alcohol Consequences Questionnaire [ Time Frame: Past month (30 days) ]
    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)



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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • not meeting inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016766


Contacts
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Contact: Eric R Pedersen 310-393-0411 ext 6078 ericp@rand.org

Sponsors and Collaborators
RAND
University of Southern California

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Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT04016766     History of Changes
Other Study ID Numbers: R34AA025968 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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