NCT03589508

Brief Summary

The purpose of this project is to develop and test indicated prevention intervention to harness support and health promoting endeavors to address use of alcohol to cope with reintegration challenges in Massachusetts National Guard (MANG) service members.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

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

Study Start

First participant enrolled

July 1, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2019

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

2.7 years

First QC Date

June 8, 2018

Last Update Submit

May 21, 2019

Conditions

Keywords

National GuardTelehealthPrevention

Outcome Measures

Primary Outcomes (4)

  • Percent Drinking Days

    Derived from Timeline Followback (TLFB)

    Change from baseline at 2 months post session 1

  • Percent Heavy Drinking Days

    Derived from Timeline Followback (TLFB)

    Change from baseline at 2 months post session 1

  • Mean Drinks Per Drinking Day

    Derived from Timeline Followback (TLFB)

    Change from baseline at 2 months post session 1

  • Attitude Items

    6 item self-report questionnaire assessing attitudes toward drinking under different circumstances. Item scores were summed to calculate total scores, with scores ranging from 6 to 24. Higher scores indicate greater attitudes about acceptability of drinking across situations.

    Baseline and through study completion, about 8 weeks

Secondary Outcomes (10)

  • Alcohol Expectancies Questionnaire 3

    Change from baseline at 2 months post Session 1

  • Coping Strategies Scale

    Change from baseline at 2 months post Session 1

  • World Health Organization Quality of Life (WHOQOL) Questionnaire - Bref

    Change from baseline at 2 months post Session 1

  • Treatment Services Review

    Weekly for up to 8 weeks

  • Couple Satisfaction Inventory 16

    Baseline and through study completion, about 8 weeks

  • +5 more secondary outcomes

Other Outcomes (6)

  • Intimate Partner Violence (IPV)

    Change from baseline at 2 months post Session 1

  • Medical History Questionnaire

    Change from baseline at 2 months post Session 1

  • Traumatic Brain Injury (TBI)

    Baseline

  • +3 more other outcomes

Study Arms (2)

In-Person Sessions: ABCP_P

EXPERIMENTAL

In-person therapy sessions: 6 Weekly Prevention Session conducted in person (half of participants will attend alone, half of participants will attend with a significant other)

Behavioral: In-person sessions: ABCP_P

Video conference sessions: ABCP_T

EXPERIMENTAL

Video conference therapy sessions: 6 Weekly Prevention Session conducted using videoconference (half of participants will attend alone, half of participants will attend with a significant other)

Behavioral: Video conference sessions: ABCP_T

Interventions

6 weekly sessions of alcohol prevention conducted in person.

In-Person Sessions: ABCP_P

6 weekly sessions of alcohol prevention conducted by video conference.

Video conference sessions: ABCP_T

Eligibility Criteria

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

You may qualify if:

  • Age 18 and older and a member of the MANG.
  • Have a SO or trusted friend who is 18 or older
  • Service member endorsed one item on the 10-item Alcohol Use Disorders Identification Test within their lifetime

You may not qualify if:

  • unable to give consent
  • Prisoners
  • Principal Investigators determined the participant requires a higher level of care (based on unstabilized psychiatric disorder, and/or high drinking or drug use severity, and/or inability to attend to adl's and/or agitated behavior
  • Service Member is unable to read or comprehend English at the 7th grade education level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Study Officials

  • Elizabeth Epstein, PhD

    UMass Worcester

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 8, 2018

First Posted

July 18, 2018

Study Start

July 1, 2016

Primary Completion

March 25, 2019

Study Completion

March 25, 2019

Last Updated

May 23, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with researchers outside of the core study team.

Locations