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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04018560
Other study ID # TIM0026
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 7, 2017
Est. completion date February 28, 2021

Study information

Verified date May 2021
Source Palo Alto Veterans Institute for Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 402
Est. completion date February 28, 2021
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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. -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Al-Anon Intensive Referral (AIR)
AIR is intended to facilitate Al-Anon participation.

Locations

Country Name City State
United States VA Palo Alto Health Care System Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Palo Alto Veterans Institute for Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. The outcome measure will be assessed up to 1 year follow-up.
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