Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04016766
Other study ID # R34AA025968
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 9, 2021
Est. completion date August 31, 2022

Study information

Verified date August 2021
Source RAND
Contact Eric R Pedersen
Phone 310-393-0411
Email ericp@rand.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date August 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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).

Locations

Country Name City State
United States University of Southern California Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
RAND University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prepartying frequency Number of days reported prepartying on the timeline followback Past month (30 days)
Primary Drinks during prepartying Average number of drinks reported during prepartying on the timeline followback Past month (30 days)
Primary Drinking frequency Number of days reported any drinking on the timeline followback Past month (30 days)
Primary Drinks on drinking days Average number of drinks reported during drinking days on the timeline followback Past month (30 days)
Primary 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)
See also
  Status Clinical Trial Phase
Completed NCT04075773 - Brief Religious Alcohol Intervention N/A
Recruiting NCT04244461 - Brief Online Intervention for Veterans N/A
Recruiting NCT05414344 - A Brief Intervention for Alcohol Users With Interpersonal Trauma N/A
Recruiting NCT05491551 - Alcohol-ROC-Training N/A
Completed NCT04639882 - Motivating Recruitment and Efficacy in Normative Feedback Interventions N/A
Completed NCT01694082 - Brief Web-Based Alcohol Reduction Intervention for Undergraduates N/A
Completed NCT00860028 - Varenicline for Smoking Cessation in Heavy Drinking Smokers Phase 2
Recruiting NCT05443555 - Gabapentin to Reduce Alcohol and Improve Viral Load Suppression Phase 2
Completed NCT04710095 - Perceived Alcohol Rewards and Risks Study N/A
Completed NCT02071836 - A Web Application to Reduce Heavy Drinking in First-time DWI Offenders N/A
Not yet recruiting NCT06420050 - Testing a Novel Instagram Intervention for Heavy Alcohol Use N/A
Recruiting NCT04450966 - Adolescent Substance Use Prevention Intervention Research Study in Pediatric Primary Care N/A
Completed NCT05189379 - Targeted Extinction of Drug Cues During Sleep - Olfactory Cue Reactivity Task N/A
Completed NCT02151591 - New Approaches to Smoking Cessation in Heavy Drinkers Phase 1
Completed NCT02478489 - Alcohol Disorder hOsPital Treatment Trial Phase 4
Recruiting NCT03235531 - Assessment of Valproate on Ethanol Withdrawal Phase 4
Completed NCT05398315 - Interactive Alcohol Decision-Making Programs N/A
Recruiting NCT05630118 - Online Insomnia Intervention to Reduce Alcohol Use N/A
Completed NCT03111056 - Web-Based Treatment of Heavy Drinking Among Women With a History of Sexual Trauma N/A
Completed NCT02664727 - Effects of Acute Exercise on Various Parameters in Individuals With Alcohol Use Disorders N/A