CompletedNot Applicable

Community Reinforcement and Family Training (CRAFT)

Denmark255 participantsStarted 2018-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Whether the drinker has sought treatment for her/his alcohol use disorder

Timeframe: 3 months after baseline

Trial details

NCT IDNCT03281057

SponsorKjeld Andersen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-30

View on ClinicalTrials.gov More CRAFT trials