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Community Reinforcement and Family Training (CRAFT) (CRAFT)

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ClinicalTrials.gov Identifier: NCT03281057
Recruitment Status : Not yet recruiting
First Posted : September 13, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Kjeld Andersen, University of Southern Denmark

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.


Condition or disease Intervention/treatment Phase
CRAFT Concern Significant Others Alcohol Use Disorder Behavioral: CRAFT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomization Clinical trial with 3 arms - individual, group, and self-help intervention.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Community Reinforcement and Family Training (CRAFT)
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Individual CRAFT
Individual CRAFT is offered to 135 participants and each participants are going to get 6 sessions.
Behavioral: CRAFT
CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment

Experimental: Group CRAFT
Open group CRAFT is offered to 135 participants in 6 sessions.
Behavioral: CRAFT
CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment

Experimental: Self-help materials
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
CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281057


Contacts
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Contact: Anette Søgaard Nielsen, Ass. Prof. +45 2913 5825 ansnielsen@health.sdu.dk
Contact: Randi Bilberg, Ass. prof. +45 21379485 rbilberg@health.sdu.dk

Locations
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Denmark
Research Unit of Psychiatry, Psychiatric Unit Odense - University function
Odense C, Denmark, 5000
Unit if Clinical Alcohol Research
Odense, Denmark, 5000
Sponsors and Collaborators
Kjeld Andersen
Investigators
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Study Chair: Anette Søgaard Nielsen, Ass. Prof. Unit of Clinical Research, University of Southern Denmark

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kjeld Andersen, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03281057     History of Changes
Other Study ID Numbers: CRAFT112018
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders