- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016766
Brief Mobile Intervention for Prepartying
August 15, 2021 updated by: RAND
Mobile Application Intervention Targeting the High Risk Drinking Practice of Prepartying
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eric R Pedersen
- Phone Number: 6078 310-393-0411
- Email: ericp@rand.org
Study Locations
-
-
California
-
Los Angeles, California, United States, 90089
- Recruiting
- University of Southern California
-
Contact:
- Eric Pedersen, PhD
- Phone Number: 310-694-7255
- Email: eric.pedersen@med.usc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prepartying mobile app intervention
Mobile app 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prepartying frequency
Time Frame: Past month (30 days)
|
Number of days reported prepartying on the timeline followback
|
Past month (30 days)
|
|
Drinks during prepartying
Time Frame: Past month (30 days)
|
Average number of drinks reported during prepartying on the timeline followback
|
Past month (30 days)
|
|
Drinking frequency
Time Frame: Past month (30 days)
|
Number of days reported any drinking on the timeline followback
|
Past month (30 days)
|
|
Drinks on drinking days
Time Frame: Past month (30 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
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)
|
Past month (30 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2021
Primary Completion (Anticipated)
May 31, 2022
Study Completion (Anticipated)
August 31, 2022
Study Registration Dates
First Submitted
July 10, 2019
First Submitted That Met QC Criteria
July 10, 2019
First Posted (Actual)
July 11, 2019
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 15, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- R34AA025968 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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