Clinical trial NCT02181283: MiSSION STRONG - Preventing AOS Misuse in the National Guard
Official title: Preventing Alcohol/Prescribed Drug Misuse in the National Guard: Web and Peer BI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: AOD Misuse
Keywords: alcohol
prescribed drugs
National Guard
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-07-03
Enrollment: 757
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: National Guard members, especially those who have been combat-deployed, are at high risk for developing alcohol- and prescription-related drug problems. The use of novel Web-based interventions combined with either Web-based boosters or Peer support sessions, may have a major public health impact for the National Guard by reducing hazardous use of alcohol of prescription drugs. The aims of the study are to develop, refine and test tailored motivational Brief Interventions (BIs) with varied continuing booster reinforcements (Web vs. Peer) and to conduct a randomized controlled trial comparing the efficacy of these BIs (W+W; W+P) to usual care on subsequent alcohol/drug consumption and consequences, including injury, mental and physical-health functioning, and HIV risk behaviors at 4-, 8-, and 12-months post-enrollment.

Detailed description: The proposed study will test the efficacy of an easy-to-use, \<40-minute, state-of-the-art tailored Web-based SBIRT (Screening, Brief Intervention, and Referral to Treatment) intervention combined with subsequent Web- or Peer-based boosters, compared to enhanced usual care (EUC). All participants will also receive a booklet with prevention information that includes general alcohol, opioid, and sedative use information as well as other health behaviors. The proposed study will screen \~ 4,300 unique Service Members as part of Soldier Readiness Processing in the Michigan National Guard (NG) to enroll 750 participants within 35 armories with alcohol and/or prescribed opioid or sedative misuse (AOS misuse). We will identify AOS misuse with a combination of the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and an adapted version of the Pain Medication Questionnaire (PMQ). Computerized screening with touch-screen computer tablets will be used to recruit NG Service Members with AOS misuse in the prior 4 months. Participants will be randomized to one of three conditions:1) Web-delivered alcohol/prescribed drug misuse brief intervention with Web booster sessions (1/month for 3 months; W+W; n=250); 2) Web-delivered brief intervention with Peer-delivered booster sessions (at least 1/month for 3 months; W+P; n=250); or 3) Enhanced Usual Care (EUC; n=250). Random assignment will be stratified by gender and alcohol vs. prescription opioid/sedative misuse.

Eligibility criteria: Inclusion Criteria:

Individuals will be eligible to participate if they are in the Michigan Army National Guard and their unit is selected to participate in the proposed study. Individuals will be eligible to participate in the randomized trial if they:

* have an AUDIT-C score of 5 or more for men and 4 or more for women in the prior 4 months, indicating that they meet criteria for at-risk drinking/alcohol misuse; and/or
* use of prescribed opioids or sedatives in the prior 4 months in a manner that was inconsistent with their prescribed course of treatment (medical misuse: determined by items from an adapted PMQ).

Exclusion Criteria:

* under 18 years of age
* inability to speak and understand English
* inability to give informed, voluntary consent
* do not have access to the Web (e.g. home, work, library, WiFi-enabled tablet PCs (iPad), etc.)

Primary outcomes:
measure: Alcohol use
timeFrame: change over time (4-, 8- and 12-months post baseline)
measure: Medical misuse of opioids or sedatives
timeFrame: change over time (4-, 8- and 12-months post baseline)
Secondary outcomes:
measure: Consequences of AOS use, including a) injury, b) mental and physical health functioning, and c) HIV-risk behaviors
timeFrame: 4-, 8- and 12-months post baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Frederic C Blow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coughlin LN, Blow FC, Walton M, Ignacio RV, Walters H, Massey L, Barry KL, McCormick R. Predictors of Booster Engagement Following a Web-Based Brief Intervention for Alcohol Misuse Among National Guard Members: Secondary Analysis of a Randomized Controlled Trial. JMIR Ment Health. 2021 Oct 26;8(10):e29397. doi: 10.2196/29397.