Community reinforcement and family training (CRAFT) - design of a cluster randomized controlled trial comparing individual, group and self-help interventions

Rikke Hellum, Anette Søgaard Nielsen, Gallus Bischof, Kjeld Andersen, Morten Hesse, Claus Thorn Ekstrøm, Randi Bilberg, Rikke Hellum, Anette Søgaard Nielsen, Gallus Bischof, Kjeld Andersen, Morten Hesse, Claus Thorn Ekstrøm, Randi Bilberg

Abstract

Background: Around 585,000 people in Denmark engage in harmful use of alcohol with 140,000 suffering from outright alcohol dependence. The concerned significant others (CSOs) are affected by the drinking, often suffering almost as much as the person with alcohol use disorder. Community Reinforcement and Family Training (CRAFT) is aimed at CSOs who struggle unsuccessfully, in an effort to motivate their loved ones to stop drinking and seek treatment. The aims of this study are 1) To implement CRAFT interventions into the daily routine of operating Danish alcohol treatment centers 2) To investigate whether 6-week-individual CRAFT, 6-week-open group-based CRAFT or CRAFT based on self-help material, is efficient in getting problem drinkers to seek treatment for their alcohol problems 3) To investigate which of the three interventions (individual, group or self-directed CRAFT) is the most effective and in which group of population.

Methods: The study is a three-arm, cluster randomized controlled trial: A: individual CRAFT, group CRAFT, and CRAFT as a self-help intervention. A total of 405 concerned significant others to persons with alcohol abuse will be recruited from 24 alcohol outpatient clinics. The participants will fill out a questionnaire regarding i.e. life quality, if the drinking person entered treatment (main outcome) and satisfaction with the intervention, at baseline and after 3 and 6 months.

Discussion: We expect to establish evidence as to whether CRAFT is efficient in a Danish treatment setting and whether CRAFT is most effective at individual, group or self-help material only.

Trial registration: Clinical trials.gov ID: NCT03281057 . Registration date: September 13th, 2017.

Keywords: Alcohol treatment; Alcohol use disorder; CRAFT; Community reinforcement and family training; Concerned significant others; Treatment engagement.

Conflict of interest statement

Ethics approval and consent to participate

This study protocol follows the Standard Protocol Items: Recommendations for interventional trials (SPIRIT) 2013 checklist for recommended items to address in a clinical trial protocol and related documents [41].

The Study is approved by the Danish Data Protection Agency (Region of Southern Denmark 2008-58-0035 project no. 17/46074). The study has been submitted for approval at the Danish Ethical Committee (Project-ID: S-20170148) but was excluded for approval on account of it being a questionnaire survey only.

All the treatment centers gave permission for the study to take place in their center.

When CSOs contact the treatment Centers, they will be informed by the therapist, both orally and in writing, about the procedures for attending the study. The CSOs must sign the informed consent document in order to participate in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Cluster-randomization of treatment institutions
Fig. 2
Fig. 2
Project time-line

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