Alcohol AbuseAFIVNCT01398319
Prevention of Alcohol Related Incidents in the US Air Force
A study testing Group Brief Alcohol Intervention, Group Brief Alcohol Intervention Booster and Bystander Intervention in people with Alcohol Abuse, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Group Brief Alcohol Intervention, Group Brief Alcohol Intervention Booster and Bystander Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26,231 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
37th Training Group
Lackland Air Force Base, Texas, 78236
About this study
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.
- Conditions
- Alcohol Abuse
- Being tested
- Group Brief Alcohol Intervention, Group Brief Alcohol Intervention Booster, Bystander Intervention
- Keywords
- prevention, alcohol abuse
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Brief Alcohol InterventionBehavioural
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.
Group Brief Alcohol Intervention BoosterBehavioural
Also called Making Responsible Choices
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.
Bystander InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Brief Alcohol Booster Intervention | Experimental | 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. Receives: Behavioral: Group Brief Alcohol Intervention; Behavioral: Group Brief Alcohol Intervention Booster |
| Bystander Intervention | Active comparator | 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. Receives: Behavioral: Group Brief Alcohol Intervention; Behavioral: Bystander Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Article 15s
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study start1 Mar 2016
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26,231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), United States Air Force
- Responsible party
- Principal investigator, Melissa Little, PhD, MPH, University of Virginia
- Investigators
- Robert C. Klesges, Ph.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398319
- Sponsor's protocol ID
- FWH20140105H
- Acronym
- AFIV
- Status last verified
- May 2022
- First submitted
- 11 Jul 2011
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Alcohol Related Incidents in the US Air Force
- ClinicalTrials.gov ID
- NCT01398319
- Acronym / sponsor ID
- AFIV / FWH20140105H
- Conditions
- Alcohol Abuse
- Keywords
- prevention, alcohol abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26,231 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), United States Air Force
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Brief Alcohol Booster Intervention | Experimental | Behavioral: Group Brief Alcohol Intervention, Behavioral: Group Brief Alcohol Intervention BoosterThe 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. |
| Bystander Intervention | Active comparator | Behavioral: Group Brief Alcohol Intervention, Behavioral: Bystander InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Brief Alcohol InterventionThe 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. | Behavioural | Bystander Intervention, Group Brief Alcohol Booster Intervention |
| Group Brief Alcohol Intervention BoosterAlso: Making Responsible ChoicesThe 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. | Behavioural | Group Brief Alcohol Booster Intervention |
| Bystander InterventionThe 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. | Behavioural | Bystander Intervention |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C. Klesges, Ph.D. principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Brief Alcohol Intervention, Group Brief Alcohol Intervention Booster and Bystander Intervention in people with Alcohol Abuse, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Article 15s (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.