Recruiting

PBS Intervention

Sponsor:

James M. Henson

Code:

NCT03510728

Conditions

College Student Drinking

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

Interventions

college drinker's check up

Protective Behavioral Strategies Intervention

Ecological Momentary Intervention

Study Details

Brief summary:

Large scale surveys indicate that approximately 68% of college students drink alcohol every month and 40% of college students engage in heavy episodic drinking. Despite prevention/intervention efforts, problematic alcohol consumption among college students continues to result in an estimated 1,800 deaths and 600,000 injuries annually, and epidemiological studies demonstrate no appreciable decrease in risk among college students. The purpose of the proposed research is to improve extant college-drinking interventions by advancing the dissemination methodology and the intervention content (Specific Aim 1). As a methodological improvement, rapid advances in mobile computing makes ecological momentary interventions (EMIs) increasingly feasible. EMIs refer to interventions that can be delivered multiple times and "in the moment". EMIs can optimize the timing and location of the intervention while also increasing the dose of the intervention. To improve the intervention content, the researchers will examine protective behavioral strategies (PBS) to reduce alcohol problems, not just alcohol use. PBS are behaviors that one can engage in immediately prior to, during, and immediately following alcohol use that limit alcohol use and/or alcohol-related harm. Research suggests that PBS use can protect individuals from alcohol problems above and beyond its effect on reducing alcohol use. The primary purpose of this research is to provide a more powerful test of a PBS intervention's effects on alcohol-related consequences by using a technology-based intervention methodology (i.e., EMI). Participants will be randomized into to a fully crossed, 3 (Standard BMI, BMI with a PBS component, control) X 2 (PBS-based EMI, Ecological Assessment Only) design. These 6 conditions will answer several critically important research questions (Specific Aim 2): a) does the addition of a PBS component improve the efficacy of a standard BMI, b) does a PBS-based EMI improve efficacy over the standard, single session BMI, c) does the combination of motivation-based intervention (BMI) with a skills-based intervention (EMI) yield even greater decreases in consequences (i.e., moderation). A final purpose of this research is to examine PBS norms, PBS perceived effectiveness, and motivation to change PBS use as novel mediators of the improved interventions. Results can be used to disseminate more effective college drinking interventions that are cheaper and more efficacious.

Conditions

College Student Drinking

Study ID

NCT03510728

Start date

Nov 15, 2017

Status verified date

Mar, 2021

Completion date

May, 2022

Anticipated

Primary completion date

May, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Current college students at the sponsor institution at the time of enrollment
  • Between the ages of 18 and 25
  • Consumed at least standard drink of alcohol in the past 4 weeks

Exclusion Criteria:

  • Under age of 18 or older than 25
  • Not a college student
  • Did not drink alcohol in the past 4 weeks

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: No single-session intervention-EMA

Participants will be assessed both using a computer and using their phone. However, they will not receive an intervention at the start of the study and will only be using their phone for ecological assessment only data collection.

active comparator: Standard single-session intervention-EMA

Participants will take a computerized BMI with known efficacy, the college drinker's check up, and will be followed up. Participants in this condition will interact with their phone only for assessment purposes.

experimental: Augment single-session intervention-EMA

Participants will take a computerized BMI with known efficacy, the college drinker's check up, and will also take a computerized intervention developed to increase the use of protective behavioral strategies during drinking (Protective Behavioral Strategies Intervention). Participants in this condition will interact with their phone only for assessment purposes.

experimental: No single-session intervention-EMI

Participants in this group will not take a single-session intervention at baseline, but will be interacting with their phones during drinking occasions to promote protective behavioral strategy use (Ecological Momentary Intervention).

experimental: Standard single-session intervention-EMI

Participants will take a computerized BMI with known efficacy, the college drinker's check up, and will be followed up. Participants in this condition will be interacting with their phones during drinking occasions to promote protective behavioral strategy use (Ecological Momentary Intervention).

experimental: Augment single-session intervention-EMI

Participants will take a computerized BMI with known efficacy, the college drinker's check up, and will also take a computerized intervention developed to increase the use of protective behavioral strategies during drinking (Protective Behavioral Strategies Intervention). Participants in this condition will be interacting with their phones during drinking occasions to promote protective behavioral strategy use (Ecological Momentary Intervention).

Interventions

college drinker's check up

The College Drinker's Check-up (CDCU) is a single session, computer-based brief motivational intervention for heavy drinking college students. It takes a student about 45 minutes to go through it.

Protective Behavioral Strategies Intervention

This intervention component focuses on educating and promoting PBS activities in future college drinking situations

Ecological Momentary Intervention

This EMI is delivered during drinking situations and focuses on promoting PBS use during that particular drinking situation.

Primary outcome measure

  • Alcohol Consumption [ Time Frame: 6-months ]
  • Alcohol Consumption [ Time Frame: 6-months ]

Central Contacts and Locations

Central contacts

James M Henson, Ph.D.

757-683-5761jhenson@odu.edu

Locations

California State University Dominguez Hills

Recruiting

Carson, California, United States, 90747

Contacts

James M Henson, PHD

757-683-5761jhenson@odu.edu

Colorado State University

Recruiting

Fort Collins, Colorado, United States, 80523

Contacts

James M Henson, PHD

757-683-5761jhenson@odu.edu

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

Old Dominion University

Recruiting

Norfolk, Virginia, United States, 23529

William and Mary

Recruiting

Williamsburg, Virginia, United States, 23187

Contacts

James M Henson, PHD

757-683-5761jhenson@odu.edu

More Information

Sponsor

James M. Henson

Last update posted

Mar 23, 2021

Last verified

Mar, 2021

Keywords

  • Protective Behavioral Strategies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by James M. Henson on 2021-03-23.