NCT04018560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

May 5, 2021

Status Verified

May 1, 2021

Enrollment Period

2.6 years

First QC Date

July 8, 2019

Last Update Submit

May 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Al-Anon Intensive Referral (AIR)

Usual care

NO INTERVENTION

Interventions

AIR is intended to facilitate Al-Anon participation.

Intervention

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (2)

  • Timko C, Cucciare MA, Lor MC, Stein M, Vest N. Patient-Concerned Other Dyads' 12-Step Involvement and Patients' Substance Use: A Latent Class Growth Model Analysis. J Stud Alcohol Drugs. 2023 Sep;84(5):762-771. doi: 10.15288/jsad.22-00378. Epub 2023 May 18.

  • 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.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 12, 2019

Study Start

March 7, 2017

Primary Completion

October 1, 2019

Study Completion

February 28, 2021

Last Updated

May 5, 2021

Record last verified: 2021-05

Locations