Project Guard: Reducing Alcohol Misuse/Abuse in the National Guard

September 28, 2021 updated by: Keming Gao

Early Intervention to Reduce Alcohol Misuse and Abuse in the Ohio Army National Guard

The overall goal for the study is to test the efficacy of a smartphone app which includes an alcohol brief intervention (SP-BI) versus an Enhanced Usual Care (EUC) condition for National Guard members in the State of Ohio who meet criteria for at-risk drinking in the previous 4 months. The main hypothesis is that those in the SP-BI group with have reduced frequency and intensity of at-risk drinking and fewer binge drinking episodes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The project is a fully-powered randomized controlled trial of a smartphone app which includes an alcohol brief intervention (SP-BI) versus an Enhanced Usual Care (EUC) condition for National Guard members in the State of Ohio, who are already participating in the Ohio Army National Guard Mental Health Initiative (OHARNG-MHI) study, titled "Resilience and Risk Factors Associated with Deployment Related Posttraumatic Psychopathology", who meet criteria for at-risk drinking in the previous 4 months. After tailoring the content of the SP-BI intervention for NG soldiers, the study will prescreen ~ 8,500 individuals over the three year enrollment period to identify 850participants with at-risk drinking. TParticipants in this study will be randomized to either the SP-BI (n=375) or the EUC condition (n=375) and followed at 4, 8 and 12 months post-enrollment. Participants who are randomized to the SP-BI condition will receive an informational brochure with resources available to members of the military related to mental health and alcohol use and will download a free app on to their smartphones. The app will be developed to be used on both Android and iPhone platforms and will be used over 12 weeks to deliver the study intervention. Those assigned to the EUC condition will receive the informational brochure only.

The specific aims of the study are to compare SP-BI and EUC in: 1) Reducing the frequency and intensity of at-risk drinking at 4 -, 8- and 12-months; 2) Decreasing binge drinking at 4-, 8- and 12 months. The secondary aims are to: 1) Compare the SP-BI and EUC conditions in reducing the frequency of illicit drug use and depressive symptoms at 4-, 8- and 12-months; 2) Examine if deployment status moderates the effect of intervention assignment (SP-BI or EUC) on post-intervention drinking, depressed feelings, and other substance use.

Study Type

Interventional

Enrollment (Actual)

850

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 Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Toledo, Ohio, United States, 43614
        • University of Toledo

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a past 4-month AUDIT-C score of 5 or more for men and 4 or more for women indicating that they meet criteria for at-risk drinking, AND
  • Do not meet any of the exclusion criteria.
  • Must be a current or former member of the Ohio Army National Guard (OHARNG) or U.S. Army Reserve based in Ohio.

Exclusion Criteria:

  • Those who do not have access to a smart phone with either Android or iOS operating system
  • Those in active treatment for substance use disorders (i.e., report addictions treatment in past 4 months) will be excluded because the proposed SBIRT intervention is focused on early brief intervention for those with at-risk drinking and on referral to treatment for those with more serious problems

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smartphone brief intervention (SP-BI)
Behavioral: Smartphone brief intervention (SP-BI)
Participants in the SP-BI group will receive a 20-30 minute intervention through an app program based on the FRAMES format: providing personalized Feedback (regarding substance use, risk factors), emphasis on Responsibility for change, Advice, Menu of options, Empathic clinical behaviors, and support of Self-efficacy regarding making changes. The intervention is designed to address the target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a "change plan".
Placebo Comparator: Enhanced Usual Care (EUC)
Other: Enhanced Usual Care (EUC)
Those assigned to EUC will receive an informational brochure with resources available to members of the military related to mental health and alcohol use. They will be contacted to complete 4-, 8-, and 12-month follow-up assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the Number of Drinking Days as Assessed by the Audit-C
Time Frame: Change over time (Baseline, 4-, 8- and 12-months post baseline)
Change over time (Baseline, 4-, 8- and 12-months post baseline)
Change in the Number of Drinks per Day as Assessed by the Audit-C
Time Frame: Change over time (Baseline, 4-, 8- and 12-months post baseline)
Change over time (Baseline, 4-, 8- and 12-months post baseline)
Change in the Number of Binge Drinking Days as Assessed by the Audit-C
Time Frame: Change over time (Baseline, 4-, 8- and 12-months post baseline)
Change over time (Baseline, 4-, 8- and 12-months post baseline)

Collaborators and Investigators

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

Sponsor

Keming Gao

Collaborators

University of Michigan
Case Western Reserve University
University of Toledo Health Science Campus

Investigators

  • Principal Investigator: Frederic C Blow, PhD, Department of Psychiatry, University of Michigan

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)

March 1, 2017

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-16-11
  • CDMRP-13277015 (Other Grant/Funding Number: U.S. Army Medical Research and Materiel Command)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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