Community Reinforcement and Family Training (CRAFT) (CRAFT)

The present study is dedicated to empowering individuals close to an addicted person (i.e. concerned significant others, CSOs) to create changes in their family environment: changes that increase the likelihood of the addicted person seeking treatment.

The Danish National Clinical Guideline for the treatment of alcohol dependence recommends that alcohol treatment centers offer interventions aimed at CSOs, providing them with the support and empowerment that will enable them to motivate the problem drinker to enter treatment. In the US, the Community Reinforcement and Family Training (CRAFT) intervention has been shown to offer the most effective support to CSOs. CRAFT has consistently demonstrated a two to three times' higher impact on getting individual with an alcohol use disorder (AUD) to attend treatment, compared to other kinds of interventions. Studies of the intervention so far have, however, been small, and the format used in the delivery of CRAFT has not been fully investigated.

The aim of the present cluster randomized controlled trial is to implement and investigate CRAFT in a Danish context and with sufficient sample size. Consecutive CSOs will through cluster randomization be randomized to receive either CRAFT in a group format, CRAFT in an individual format, or a control condition, consisting of self-help material only. The primary outcome of the study will be the rate of individuals with AUD entering treatment following the intervention targeted at the CSOs within three months from its initiation. Data will be collected from all CSOs at baseline, three, and six months after baseline.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder; CRAFT; Concern Significant Others
• Intervention / Treatment: Behavioral: CRAFT

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Unit if Clinical Alcohol Research
  • Odense C, Denmark, 5000
    • Research Unit of Psychiatry, Psychiatric Unit Odense - University function

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 18 years and older
• Being a CSO to a person with AUD who is not currently in treatment for alcohol problems
• Having the intention to maintain the contact during the next 90 days
• Having had regular contact with the problem drinker for the last 90 days (face-to-face contact for several hours on at least a weekly basis) and having the intention to maintain the contact during the next 90 days.
• Being prepared support the problem drinker if he/she chooses to seek treatment, at least to some extent.

Exclusion Criteria:

• Suffering from dementia or other cognitive disorders
• Not speaking Danish
• Being psychotic or otherwise severely mentally ill
• Suffering from AUD in the last three months
• Being concerned about a person who, according to the CSO, mainly use illegal substances

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individual CRAFT; Individual CRAFT is offered to 135 participants and each participants are going to get 6 sessions.	Behavioral: CRAFT; CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment
Experimental: Group CRAFT; Open group CRAFT is offered to 135 participants in 6 sessions.	Behavioral: CRAFT; CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment
Experimental: Self-help materials; Self-help materials (control group) are going to be offered a self-help book, because it is unethically not to offer any intervention, as the CRAFT intervention in early studies have shown to be very effectful	Behavioral: CRAFT; CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whether the drinker has sought treatment for her/his alcohol use disorder	The proportion of problem drinkers, who enter alcohol treatment centers from baseline and until three months after their CSOs enrolled in the CRAFT study.	3 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the anxiety, - depression and concern symptoms of concern significant others following CRAFT intervention		3 and 6 months after baseline
Improvement in the relationship between the concern significant other and the drinker before and after CRAFT intervention	Measured by the Relationship Happiness Scale	3 and 6 months after baseline
Changes in number of sick leave days for concern significant others from 6 months before to 6 months after enrollment in the study.		6 months after baseline
Changes in quality of life among concern significant others.	Measured by WHO's quality of life scale "WHOQol-Bref - Danish version"	3 and 6 months after baseline

Collaborators and Investigators

• Sponsor: Kjeld Andersen
• Investigators: Study Chair: Anette Søgaard Nielsen, Ass. Prof., Unit of Clinical Research, University of Southern Denmark

Publications and helpful links

General Publications

• Hellum R, Bilberg R, Andersen K, Bischof G, Hesse M, Nielsen AS. Primary Outcome from a cluster-randomized trial of three formats for delivering Community Reinforcement and Family Training (CRAFT) to the significant others of problem drinkers. BMC Public Health. 2022 May 10;22(1):928. doi: 10.1186/s12889-022-13293-8.
• Hellum R, Nielsen AS, Bischof G, Andersen K, Hesse M, Ekstrom CT, Bilberg R. Community reinforcement and family training (CRAFT) - design of a cluster randomized controlled trial comparing individual, group and self-help interventions. BMC Public Health. 2019 Mar 14;19(1):307. doi: 10.1186/s12889-019-6632-5.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: CRAFT112018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No