NCT02181283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
757

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

3.2 years

First QC Date

June 26, 2014

Last Update Submit

May 31, 2018

Conditions

AOD Misuse

Keywords

alcoholprescribed drugsNational Guard

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (1)

  • Consequences of AOS use, including a) injury, b) mental and physical health functioning, and c) HIV-risk behaviors

    4-, 8- and 12-months post baseline

Study Arms (3)

W+W

ACTIVE COMPARATOR

Web-delivered alcohol/prescribed drug misuse brief intervention with Web booster sessions (W+W).

Behavioral: W+W

W+P

ACTIVE COMPARATOR

Web-delivered brief intervention with Peer-delivered booster sessions (W+P).

Behavioral: W+P

Enhanced Usual Care

NO INTERVENTION

Enhanced usual care.

Interventions

W+WBEHAVIORAL

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.

Also known as: Web-delivered brief intervention with Web booster sessions
W+W
W+PBEHAVIORAL

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.

Also known as: Web-delivered brief intervention with Peer-delivered booster sessions
W+P

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

  • Blow FC, Walton M, Ilgen M, Ignacio RV, Walters H, Massey L, Barry KL, McCormick R, Coughlin LN. Peer- and web-based interventions for risky drinking among US National Guard members: Mission Strong randomized controlled trial. Addiction. 2023 Jul;118(7):1246-1257. doi: 10.1111/add.16172. Epub 2023 Apr 11.

    PMID: 37041669DERIVED

  • 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.

    PMID: 34698652DERIVED

Study Officials

  • Frederic C Blow, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2014

First Posted

July 3, 2014

Study Start

April 1, 2015

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

June 1, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)