Prevention of Alcohol Related Incidents in the US Air Force (AFIV)

May 20, 2022 updated by: Melissa Little, PhD, MPH, University of Virginia
Alcohol misuse poses significant public health concerns in the U.S. military. A Brief Alcohol Intervention (BAI) have been shown to reduce alcohol related incidents among Airmen undergoing training. The current study sought to examine whether a booster BAI administered at the end of an Airmen's training reduced alcohol related incidents out to a one-year follow-up. Participants were 26,231 US Air Force Technical Trainees recruited between March 2016 and July 2018. Participants were cluster randomized by cohort to two conditions: BAI + BAI Booster or BAI + Bystander Intervention. The primary analysis was a comparison of the interventions' efficacies in preventing Article 15 alcohol related incidents at a one-year follow-up, conducted using a generalized estimating equations logistic regression model controlling for covariates.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26231

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • United States
    • Texas
      • Lackland Air Force Base, Texas, United States, 78236
        • 37th Training Group

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Participants were Airmen undergoing Technical Training at five military bases (Lackland Air Force Base, Keesler Air Force Base, Sheppard Air Force Base, Goodfellow Air Force Base and Fort Sam Houston) in Texas and Mississippi from March 2016 through July 2018. Eligibility criteria included being at least 18 years of age and understanding the consent process in English.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group Brief Alcohol Booster Intervention
The 1-hour booster intervention was delivered using MI to extend the effective elements found in the original BAI intervention with elements from behavioral economic theory. A behavioral economic approach to alcohol use suggests that decisions to drink are more likely when 1) there is a lack of access to or engagement in alternative alcohol-free reinforcing activities, and 2) there is a greater relative focus on immediate, relative to delayed, rewards (i.e., steep delayed reward discounting). The intent of the intervention is to bring important long-term goals into the present so that the immediate awareness of this goal might diminish the relative benefit of drinking. Another goal was to have the Airmen identify enjoyable and goal-consistent alcohol-free activities they could engage in during their free time. The booster also included a reminder of the U.S. Air Forces rules and policies on alcohol use and harm reduction drinking strategies.
Behavioral: Group Brief Alcohol Intervention
The BAI contained components of effective interventions developed for young adult drinkers both in health care and educational settings and was specifically tailored to the unique needs and risk factors of Airmen. The 1-hour group intervention was administered using the principles of motivational interviewing (MI) in an interactive Socratic style to generate feedback and discussion. Open-ended questions, reflections, as well as the decisional balance scale were used to increase Airmen's motivation to remain alcohol free.
Behavioral: Group Brief Alcohol Intervention Booster
The 1-hour booster intervention was delivered using MI to extend the effective elements found in the original BAI intervention with elements from behavioral economic theory. A behavioral economic approach to alcohol use suggests that decisions to drink are more likely when 1) there is a lack of access to or engagement in alternative alcohol-free reinforcing activities, and 2) there is a greater relative focus on immediate, relative to delayed, rewards (i.e., steep delayed reward discounting). The intent of the intervention is to bring important long-term goals into the present so that the immediate awareness of this goal might diminish the relative benefit of drinking. Another goal was to have the Airmen identify enjoyable and goal-consistent alcohol-free activities they could engage in during their free time. The booster also included a reminder of the U.S. Air Forces rules and policies on alcohol use and harm reduction drinking strategies.
Other Names:
  • Making Responsible Choices
Active Comparator: Bystander Intervention
The 1-hour Bystander intervention was a non-alcohol related briefing that served as the control condition. The intervention focused on increasing Airmen's awareness of the qualities of being a good "wingman" (e.g., watching for their peers) and how those are tied to the Air Force Core Values. It aimed to increase participants' perceived responsibility to act in certain situations. The intervention draws on the philosophy that members in a community have a role in shifting social norms to prevent violence. While the intervention did not directly discuss alcohol use, the focus on military values and taking responsibility for one's self and others could contribute to healthier drinking-related choices.
Behavioral: Group Brief Alcohol Intervention
The BAI contained components of effective interventions developed for young adult drinkers both in health care and educational settings and was specifically tailored to the unique needs and risk factors of Airmen. The 1-hour group intervention was administered using the principles of motivational interviewing (MI) in an interactive Socratic style to generate feedback and discussion. Open-ended questions, reflections, as well as the decisional balance scale were used to increase Airmen's motivation to remain alcohol free.
Behavioral: Bystander Intervention
The 1-hour Bystander intervention was a non-alcohol related briefing that served as the control condition. The intervention focused on increasing Airmen's awareness of the qualities of being a good "wingman" (e.g., watching for their peers) and how those are tied to the Air Force Core Values. It aimed to increase participants' perceived responsibility to act in certain situations. The intervention draws on the philosophy that members in a community have a role in shifting social norms to prevent violence (Coker et al., 2011). While the intervention did not directly discuss alcohol use, the focus on military values and taking responsibility for one's self and others could contribute to healthier drinking-related choices.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Article 15s
Time Frame: 12 months
Adjudicated alcohol related incident in the United States Air Force (Article 15). We determined if an Airmen had received an Article 15 in the year following Technical Training by searching the Automated Military Justice Analysis and Management System (AMJAMS).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
United States Air Force

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert C. Klesges, Ph.D., University of Virginia

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FWH20140105H

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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