Community Reinforcement and Family Training (CRAFT)

NCT03281057 | Completed DMC

• 1 other identifier: CRAFT112018
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

CRAFT; Concern Significant Others; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  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.

  3 and 6 months after baseline

Study Arms (3)

Individual CRAFT

EXPERIMENTAL

Individual CRAFT is offered to 135 participants and each participants are going to get 6 sessions.

Behavioral: CRAFT

Group CRAFT

EXPERIMENTAL

Open group CRAFT is offered to 135 participants in 6 sessions.

Behavioral: CRAFT

Self-help materials

EXPERIMENTAL

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

Interventions

CRAFT BEHAVIORAL

CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment

Group CRAFT; Individual CRAFT; Self-help materials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kjeld Andersen: lead

Study Sites (2)

Unit if Clinical Alcohol Research

Odense, 5000, Denmark

Location

Research Unit of Psychiatry, Psychiatric Unit Odense - University function

Odense C, 5000, Denmark

Location

Related Publications (2)

• 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.

  PMID: 35538465 DERIVED

• 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.

  PMID: 30871596 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Anette Søgaard Nielsen, Ass. Prof.

  Unit of Clinical Research, University of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Cluster randomization Clinical trial with 3 arms - individual, group, and self-help intervention.

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 13, 2017
• Study Start: January 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)