Clinical trial NCT03281057: Community Reinforcement and Family Training (CRAFT)
Official title: Community Reinforcement and Family Training (CRAFT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CRAFT
Concern Significant Others
Alcohol Use Disorder
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomization Clinical trial with 3 arms - individual, group, and self-help intervention.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Whether the drinker has sought treatment for her/his alcohol use disorder
timeFrame: 3 months after baseline
Secondary outcomes:
measure: Changes in the anxiety, - depression and concern symptoms of concern significant others following CRAFT intervention
timeFrame: 3 and 6 months after baseline
measure: Improvement in the relationship between the concern significant other and the drinker before and after CRAFT intervention
timeFrame: 3 and 6 months after baseline
measure: Changes in number of sick leave days for concern significant others from 6 months before to 6 months after enrollment in the study.
timeFrame: 6 months after baseline
measure: Changes in quality of life among concern significant others.
timeFrame: 3 and 6 months after baseline
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Research Unit of Psychiatry, Psychiatric Unit Odense - University function
city: Odense
country: Denmark
facility: Unit if Clinical Alcohol Research
Study officials:
affiliation: Unit of Clinical Research, University of Southern Denmark
name: Anette Søgaard Nielsen, Ass. Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.