Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse Abuse (PC)

September 27, 2017 updated by: Karen Osilla, RAND

Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse

The purpose of this study is to adapt and pilot-test a web-based intervention intended to help concerned partners provide support to service members with alcohol misuse and to begin development of a service member module based on service member's input.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

U.S. military service members engaged in alcohol misuse are a vulnerable population with high unmet need. Alcohol misuse is a stage of problem drinking that occurs before abuse and dependence, placing service members' partners and families at risk for serious consequences. Unfortunately, existing military reporting policies may discourage service members from seeking help for fear of negative career consequences. Service members report encouragement from their partners as the most prevalent facilitator of seeking care and individuals who change their drinking patterns most often cite partner support as the most helpful mechanism in supporting change. Thus, targeting service members' partners using preventive interventions can be an important vehicle for preventing the progression to abuse and dependence. A 3-year study is proposed to adapt and pilot-test a web-based intervention (WBI) intended to help concerned partners (CPs) provide support to service members with alcohol misuse and to begin development of a service member module based on service member's input. First, an evidence-based intervention known as Community Reinforcement and Family Training (CRAFT) intervention will be adapted to the web. The specific aims are as follows: Aim 1: Develop a 4-session web-based intervention (WBI) prototype and make iterative revisions based on feedback from 15-20 CPs. Aim 2: Conduct a randomized controlled pilot-test of the finalized WBI (n=50) compared to delayed WBI (n=50), and evaluate the impact of the WBI on CP's reports of service member help-seeking (e.g., counseling, self-help, primary care, treatment) and drinking, and CP well-being and relationship satisfaction three months after the intervention. Aim 3: Begin development of a follow-on WBI module for service members based on service member input and content evaluation. Service members will be asked their intervention preferences and feedback on a proposed WBI for them. This project is significant because it has the potential to benefit a large population of military service members who may be disproportionately affected by the current OEF/OIF/OND conflicts and whose drinking misuse would otherwise go undetected and untreated. It also develops a new prevention model that does not rely on service members or partners attending a hospital or clinical facility to access care. The proposed study is innovative because there are no CP-based preventive interventions addressing misuse. This pilot study will inform the development of an R01 trial that evaluates a larger randomized study of a WBI for CPs with a follow-on intervention for service members.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
312

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • California
      • Santa Monica, California, United States, 90407
        • RAND

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. if they are currently living with their partner,
  2. if they have had contact with their partner at least 40% of the time in the past 90 days (e.g., most of the evenings or most of the days in a given week),
  3. if they are in a romantic relationship with the service member,
  4. if they have a computer they can use in a private area,
  5. if the CP and service member are at least 18 years of age,
  6. if their partner is currently an active duty service member,
  7. if the CP or service member has not attended couples or drug/alcohol counseling in the past 60 days,
  8. if the CP does not plan to separate from their partner in the next 60 days,
  9. if they feel their partner has a problem with their drinking, and
  10. if they do not endorse any domestic violence in the past year. -

Exclusion Criteria:

  1. if the CP plans to seek counseling in the next 90 days, and/or
  2. reports feeling unsafe to discuss drinking with his/her partner -

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Web Brief Intervention (WBI)
4-session WBI
Behavioral: Web Brief Intervention (WBI)
4-session WBI
No Intervention: Delayed-WBI
4-session WBI after follow-up

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceptions of Partner's Drinking
Time Frame: Three months after intervention
DNRF: "Consider a typical week during the past month (30 days). How much alcohol, on average, (measured in number of drinks), do you think your partner had on each day of a typical week?"
Three months after intervention
Concern about Partner's Drinking
Time Frame: Three months after intervention
Thinking about your Partner's Drinking (TPD): http://www.sciencedirect.com/science/article/pii/S0306460313002517
Three months after intervention
Partner's readiness to change
Time Frame: Three months after intervention
On a scale from 0 to 10, how ready do you feel your partner is to change his/her drinking?
Three months after intervention
Partner help-seeking
Time Frame: Three months after intervention
On a scale from 0 to 10, how ready do you think your partner feels about seeking help for their drinking (for example, talking with a counselor or going to AA meetings regularly).
Three months after intervention
Relationship Quality
Time Frame: Three months after intervention
Quality Marriage Index (QMI): Norton, R. (1983). Measuring marital quality: A critical look at the dependent variable. Journal of Marriage and Family, 45, 141-151.
Three months after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CP Depression and Anxiety
Time Frame: Three months after intervention
PHQ-8 and BAI
Three months after intervention
Family Environment
Time Frame: Three months after intervention
Family Environment Scale (FES)
Three months after intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RAND

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen C Osilla, PhD, RAND

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34AA023123 (U.S. NIH Grant/Contract)

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings