MiSSION STRONG - Preventing AOS Misuse in the National Guard

AOD Misuse Clinical Trial

Official title:

Preventing Alcohol/Prescribed Drug Misuse in the National Guard: Web and Peer BI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181283
• Other study ID #: AA023122
• Secondary ID: 1R01AA023122-01
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: May 31, 2018

Study information

• Verified date: May 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 757
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• AOD Misuse

Intervention

Behavioral:
• W+W
Web-delivered brief intervention: Participants receive a 30-40 minute Web-based intervention which includes a tailored review of participants' goals/values, feedback regarding their present alcohol/prescribed opioid/sedative use patterns and consequences, developing a discrepancy between their alcohol or prescribed drug use, ability to meet goals and values through a decisional balance exercise, and formulation of a tailored "change plan". Web booster sessions: Web boosters will be completed at 1, 2 and 3 months post-BI. Content is tailored to the individual based on answers to baseline questions and responses during Web-based BI. Web-based Booster will: 1) briefly ascertain current AOS use, 2) changes in AOS since completing Web BI, 3) progress toward goals, and 4) plans and encouragement for next steps.
• W+P
Web-delivered brief intervention: Participants receive a 30-40 minute Web-based intervention which includes a tailored review of participants' goals/values, feedback regarding their present alcohol/prescribed opioid/sedative use patterns and consequences, developing a discrepancy between their alcohol or prescribed drug use, ability to meet goals and values through a decisional balance exercise, and formulation of a tailored "change plan". Peer booster sessions: The peer supporter will work with participants at 1, 2, and 3 months post-Web-based BI. Peer supports will address Service Members' own goals and will provide emotional and informational support.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol use	The full AUDIT which includes the AUDIT-C, will be used to assess alcohol use. Quantity and frequency is measured by number of drinking days, number of drinks per day and number of binge drinking days. Alcohol related consequences are measured using the modified SIP.	change over time (4-, 8- and 12-months post baseline)
Primary	Medical misuse of opioids or sedatives	Quantity and frequency is measured by number of days misused, and the NIDA-Modified ASSIST and adapted Pain Medication Questionnaire (PMQ) are used to assess medical misuse of prescribed opioids and medical misuse of prescribed sedatives. Consequences are measured using the modified SIP.	change over time (4-, 8- and 12-months post baseline)
Secondary	Consequences of AOS use, including a) injury, b) mental and physical health functioning, and c) HIV-risk behaviors	3a) Injury is measured using the Revised Injury Behavior Checklist (RIBC). 3b) Mental and physical health functioning is measured using a brief version of the Short Form Health Survey (SF-12), the Generalized Anxiety Disorder (GAD-7) questionnaire, the Patient Health Questionnaire (PHQ), the Post-Traumatic Disorder Checklist-Military Version (PCL-5) and items from the Unit Risk Inventory, developed by the Army Substance Abuse Program.; 3c) HIV-risk behaviors are measured using questions from the HIV Risk-Taking Behavior Scale (HRBS).	4-, 8- and 12-months post baseline