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

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Al-Anon Intensive Referral (AIR)
Sponsored by
Palo Alto Veterans Institute for Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Use Disorder

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. the drinker is an adult (≥19 years old) entering a treatment episode for the primary substance of alcohol;
  2. 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
  3. the drinker and CO can communicate in English. -

Exclusion Criteria:

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

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Mental Health
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.

Secondary Outcome Measures

Full Information

First Posted
July 8, 2019
Last Updated
May 4, 2021
Sponsor
Palo Alto Veterans Institute for Research
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1. Study Identification

Unique Protocol Identification Number
NCT04018560
Brief Title
Intensive Referral to Al-Anon: Benefits to Concerned Others and Their Drinkers
Official Title
Intensive Referral to Al-Anon: Benefits to Concerned Others and Their Drinkers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto Veterans Institute for Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Al-Anon Intensive Referral (AIR)
Intervention Description
AIR is intended to facilitate Al-Anon participation.
Primary Outcome Measure Information:
Title
Mental Health
Description
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.
Time Frame
The outcome measure will be assessed up to 1 year follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34427006
Citation
Timko C, Grant KM, Han X, Young LB, Cucciare MA. Al-Anon Intensive Referral to facilitate concerned others' participation in Al-Anon Family Groups: a randomized controlled trial. Addiction. 2022 Mar;117(3):590-599. doi: 10.1111/add.15670. Epub 2021 Oct 3.
Results Reference
derived

Learn more about this trial

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

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