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Completed

NCT Number: NCT03281057

Community Reinforcement and Family Training (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit if Clinical Alcohol Research, Odense, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRAFT

Behavioral

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

Primary outcomes

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

    Time frame: 3 months after baseline

    The proportion of problem drinkers, who enter alcohol treatment centers from baseline and until three months after their CSOs enrolled in the CRAFT study.

Secondary outcomes

  1. Changes in the anxiety, - depression and concern symptoms of concern significant others following CRAFT intervention

    Time frame: 3 and 6 months after baseline

  2. Improvement in the relationship between the concern significant other and the drinker before and after CRAFT intervention

    Time frame: 3 and 6 months after baseline

    Measured by the Relationship Happiness Scale

  3. Changes in number of sick leave days for concern significant others from 6 months before to 6 months after enrollment in the study.

    Time frame: 6 months after baseline

  4. Changes in quality of life among concern significant others.

    Time frame: 3 and 6 months after baseline

    Measured by WHO's quality of life scale "WHOQol-Bref - Danish version"

Sponsors and collaborators

Lead sponsor

Kjeld Andersen

Other

Registry information

Acronym: CRAFT

Important dates

Study start
2018
Primary completion
2020
Study completion
2023
First posted
Sep 13, 2017
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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