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Alcohol AbusePCNCT02073825

Web Intervention for Concerned Partners to Prevent Service Member Alcohol Abuse Abuse

A study testing Web Brief Intervention (WBI) in people with Alcohol Abuse, run by RAND at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Alcohol Abuse
What is being tested?
Web Brief Intervention (WBI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
1 siteUnited States
Study dates
Nov 2014to 31 Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • if they are currently living with their partner,
  • 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),
  • if they are in a romantic relationship with the service member,
  • if they have a computer they can use in a private area,
  • if the CP and service member are at least 18 years of age,
  • if their partner is currently an active duty service member,
Show all 10Show fewer
  • if the CP or service member has not attended couples or drug/alcohol counseling in the past 60 days,
  • if the CP does not plan to separate from their partner in the next 60 days,
  • if they feel their partner has a problem with their drinking, and
  • if they do not endorse any domestic violence in the past year. -

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • RAND

    Santa Monica, California, 90407

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Alcohol Abuse
Being tested
Web Brief Intervention (WBI)
Keywords
Computer-assisted interventions, Alcohol use disorders, At-risk drinking, Spouses, Military, Brief Intervention
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web Brief Intervention (WBI)Behavioural

    4-session WBI

Study groups in NCT02073825
Study groupRoleWhat they receive
Web Brief Intervention (WBI)Experimental4-session WBI
Receives: Behavioral: Web Brief Intervention (WBI)
Delayed-WBINo intervention4-session WBI after follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceptions of Partner's Drinking

    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?"

    Measured: Three months after intervention

  2. Concern about Partner's Drinking

    Thinking about your Partner's Drinking (TPD): http://www.sciencedirect.com/science/article/pii/S0306460313002517

    Measured: Three months after intervention

  3. Partner's readiness to change

    On a scale from 0 to 10, how ready do you feel your partner is to change his/her drinking?

    Measured: Three months after intervention

  4. Partner help-seeking

    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).

    Measured: Three months after intervention

  5. Relationship Quality

    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.

    Measured: Three months after intervention

Secondary outcomes (2)

  1. CP Depression and Anxiety

    PHQ-8 and BAI

    Measured: Three months after intervention

  2. Family Environment

    Family Environment Scale (FES)

    Measured: Three months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionOct 2015
  4. Study completion31 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02073825
Sponsor's protocol ID
R34AA023123
Other IDs
R34AA023123
Acronym
PC
Status last verified
Sep 2017
First submitted
20 Feb 2014
Last updated
29 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • Osilla KC, Pedersen ER, Gore K, Trail T, Howard SS. Study design to develop and pilot-test a web intervention for partners of military service members with alcohol misuse. Addict Sci Clin Pract. 2014 Sep 2;9(1):18. doi: 10.1186/1940-0640-9-18.

    PubMed 25179672

  • Osilla KC, Pedersen ER, Tolpadi A, Howard SS, Phillips JL, Gore KL. The Feasibility of a Web Intervention for Military and Veteran Spouses Concerned About Their Partner's Alcohol Misuse. J Behav Health Serv Res. 2018 Jan;45(1):57-73. doi: 10.1007/s11414-016-9546-3.

    PubMed 28039559

  • Pedersen, E. R., Osilla, K. C., Helmuth, E. D., Tolpadi, A., & Gore, K. (2017). Reaching Concerned Partners of Heavy Drinking Service Members and Veterans through Facebook. Military Behavioral Health, 5:3, 265-273, DOI: 10.1080/21635781.2017.1316804

  • Rodriguez LM, Osilla KC, Trail TE, Gore KL, Pedersen ER. Alcohol Use Among Concerned Partners of Heavy Drinking Service Members and Veterans. J Marital Fam Ther. 2018 Apr;44(2):277-291. doi: 10.1111/jmft.12261. Epub 2017 Aug 7.

    PubMed 28782116

  • Trail TE, Osilla KC, Rodriguez LM, Pedersen ER, Gore KL. Exploring the association between changes in partner behaviors, perceived service member drinking, and relationship quality: Secondary analysis of a web-based intervention for military partners. J Subst Abuse Treat. 2019 Mar;98:66-72. doi: 10.1016/j.jsat.2019.01.002. Epub 2019 Jan 3.

    PubMed 30665606

Questions about this trial

What is this clinical trial studying?

A study testing Web Brief Intervention (WBI) in people with Alcohol Abuse, run by RAND at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceptions of Partner's Drinking (time frame: Three months after intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02073825, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.

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