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Completed

NCT Number: NCT04018560

Intensive Referral to Al-Anon: Benefits to Concerned Others and Their Drinkers

This study is examining the effectiveness of Al-Anon Intensive Referral (AIR) with Concerned Others (COs) of individuals in treatment for alcohol use disorders ("drinkers"). AIR's goal is to facilitate Al-Anon participation and positive outcomes among COs.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

About this study

In a randomized controlled trial, this 4-year project is evaluating AIR's effectiveness for COs. COs and their drinkers are assessed at baseline and 3-month, 6-month, and 1-year follow-ups. Hypotheses are that, compared to usual care, AIR will increase Al-Anon participation and improve CO outcomes. We will examine hypotheses using generalized mixed-effects regression models (GLMM). This project is built on the foundation that it is essential to help COs because of their own suffering.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the drinker is an adult (≥19 years old) entering a treatment episode for the primary substance of alcohol;
  • the drinker signs a release for researchers to contact a CO (also an adult) he or she identifies as a family member or close friend who has had contact with the drinker on at least 12 (40%) of the past 30 days; and
  • the drinker and CO can communicate in English. -

Exclusion criteria

  • the drinker is <19 years old, not entering a treatment episode for alcohol use disorder;
  • the drinker does not sign a release for researchers to contact a CO;
  • the drinker and CO cannot communicate in English. -

Treatment and study plan

Al-Anon Intensive Referral (AIR)

Behavioral

AIR is intended to facilitate Al-Anon participation.

Primary outcomes

  1. Mental Health

    Time frame: The outcome measure will be assessed up to 1 year follow-up.

    Items are rated on a 5-point scale (0=never, 4=very often). Mental Health is the mean of 10 items (e.g., How often have you experienced feeling hopeful); negative symptoms (e.g., anxious) are reverse scored.

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Jul 12, 2019
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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