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Community Reinforcement and Family Training (CRAFT) (CRAFT)

Primary Purpose

CRAFT, Concern Significant Others, Alcohol Use Disorder

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CRAFT
Sponsored by
Kjeld Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CRAFT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Unit of Psychiatry, Psychiatric Unit Odense - University function
  • Unit if Clinical Alcohol Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Individual CRAFT

Group CRAFT

Self-help materials

Arm Description

Individual CRAFT is offered to 135 participants and each participants are going to get 6 sessions.

Open group CRAFT is offered to 135 participants in 6 sessions.

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

Outcomes

Primary Outcome Measures

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

Changes in the anxiety, - depression and concern symptoms of concern significant others following CRAFT intervention
Improvement in the relationship between the concern significant other and the drinker before and after CRAFT intervention
Measured by the Relationship Happiness Scale
Changes in number of sick leave days for concern significant others from 6 months before to 6 months after enrollment in the study.
Changes in quality of life among concern significant others.
Measured by WHO's quality of life scale "WHOQol-Bref - Danish version"

Full Information

First Posted
September 8, 2017
Last Updated
February 4, 2022
Sponsor
Kjeld Andersen
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1. Study Identification

Unique Protocol Identification Number
NCT03281057
Brief Title
Community Reinforcement and Family Training (CRAFT)
Acronym
CRAFT
Official Title
Community Reinforcement and Family Training (CRAFT)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kjeld Andersen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CRAFT, Concern Significant Others, Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomization Clinical trial with 3 arms - individual, group, and self-help intervention.
Masking
Participant
Allocation
Randomized
Enrollment
255 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individual CRAFT
Arm Type
Experimental
Arm Description
Individual CRAFT is offered to 135 participants and each participants are going to get 6 sessions.
Arm Title
Group CRAFT
Arm Type
Experimental
Arm Description
Open group CRAFT is offered to 135 participants in 6 sessions.
Arm Title
Self-help materials
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
CRAFT
Intervention Description
CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment
Primary Outcome Measure Information:
Title
Whether the drinker has sought treatment for her/his alcohol use disorder
Description
The proportion of problem drinkers, who enter alcohol treatment centers from baseline and until three months after their CSOs enrolled in the CRAFT study.
Time Frame
3 months after baseline
Secondary Outcome Measure Information:
Title
Changes in the anxiety, - depression and concern symptoms of concern significant others following CRAFT intervention
Time Frame
3 and 6 months after baseline
Title
Improvement in the relationship between the concern significant other and the drinker before and after CRAFT intervention
Description
Measured by the Relationship Happiness Scale
Time Frame
3 and 6 months after baseline
Title
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
Title
Changes in quality of life among concern significant others.
Description
Measured by WHO's quality of life scale "WHOQol-Bref - Danish version"
Time Frame
3 and 6 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anette Søgaard Nielsen, Ass. Prof.
Organizational Affiliation
Unit of Clinical Research, University of Southern Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Research Unit of Psychiatry, Psychiatric Unit Odense - University function
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Unit if Clinical Alcohol Research
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35538465
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.
Results Reference
derived
PubMed Identifier
30871596
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.
Results Reference
derived
Links:
URL
http://www.sdu.dk/en/om_sdu/institutter_centre/ucar
Description
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Community Reinforcement and Family Training (CRAFT)

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