CRAFTCRAFTNCT03281057
Community Reinforcement and Family Training (CRAFT)
A study testing CRAFT in people with CRAFT and Concern Significant Others, run by Kjeld Andersen at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRAFT, Concern Significant Others, Alcohol Use Disorder
- What is being tested?
- CRAFT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jan 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Unit if Clinical Alcohol Research
Odense, 5000
Research Unit of Psychiatry, Psychiatric Unit Odense - University function
Odense C, 5000
About this study
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.
- Conditions
- CRAFT, Concern Significant Others, Alcohol Use Disorder
- Being tested
- CRAFT
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRAFTBehavioural
CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment
| Study group | Role | What they receive |
|---|---|---|
| Individual CRAFT | Experimental | Individual CRAFT is offered to 135 participants and each participants are going to get 6 sessions. Receives: Behavioral: CRAFT |
| Group CRAFT | Experimental | Open group CRAFT is offered to 135 participants in 6 sessions. Receives: Behavioral: CRAFT |
| Self-help materials | Experimental | 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 Receives: Behavioral: CRAFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after baseline
Secondary outcomes (4)
Changes in the anxiety, - depression and concern symptoms of concern significant others following CRAFT intervention
Measured: 3 and 6 months after baseline
Improvement in the relationship between the concern significant other and the drinker before and after CRAFT intervention
Measured by the Relationship Happiness Scale
Measured: 3 and 6 months after baseline
Changes in number of sick leave days for concern significant others from 6 months before to 6 months after enrollment in the study.
Measured: 6 months after baseline
Changes in quality of life among concern significant others.
Measured by WHO's quality of life scale "WHOQol-Bref - Danish version"
Measured: 3 and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Jan 2018
- Primary completion30 Jun 2020
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CRAFTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomization Clinical trial with 3 arms - individual, group, and self-help intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kjeld Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kjeld Andersen, University of Southern Denmark
- Investigators
- Anette Søgaard Nielsen, Ass. Prof., Study chair, Unit of Clinical Research, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281057
- Sponsor's protocol ID
- CRAFT112018
- Acronym
- CRAFT
- Status last verified
- Mar 2025
- First submitted
- 8 Sep 2017
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35538465Hellum 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.
PubMed 30871596
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Reinforcement and Family Training (CRAFT)
- ClinicalTrials.gov ID
- NCT03281057
- Acronym / sponsor ID
- CRAFT / CRAFT112018
- Conditions
- CRAFT, Concern Significant Others, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Kjeld AndersenUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Cluster randomization Clinical trial with 3 arms - individual, group, and self-help intervention.
| Arm | Type | Receives |
|---|---|---|
| Individual CRAFT | Experimental | Behavioral: CRAFTIndividual CRAFT is offered to 135 participants and each participants are going to get 6 sessions. |
| Group CRAFT | Experimental | Behavioral: CRAFTOpen group CRAFT is offered to 135 participants in 6 sessions. |
| Self-help materials | Experimental | Behavioral: CRAFTSelf-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRAFTCRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment | Behavioural | Group CRAFT, Individual CRAFT, Self-help materials |
Primary outcome
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.
4 secondary outcomes
Changes in the anxiety, - depression and concern symptoms of concern significant others following CRAFT intervention
Time frame: 3 and 6 months after baseline
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
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
Changes in quality of life among concern significant others.
Time frame: 3 and 6 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 35538465Hellum 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.
- Derived from this study: PubMed 30871596Hellum 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.
- Individual participant dataSharing planned: No
Related trials for CRAFT
Not yet recruiting
Engaging Family Members During Early SUD Treatment: A Hybrid Trial
Substance Use Disorder (SUD)
Active, not recruitingObservational study
The Euro-CRAFT Registry
Coronary Microvascular Disease
Recruiting
Phase II: Scalable Digital Delivery of CRAFT Training for Professionals to Maximize Treatment Rates of OUD in Families
Community Reinforcement And Family Training, Family Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anette Søgaard Nielsen, Ass. Prof. study chair
Unit of Clinical Research, University of Southern Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRAFT in people with CRAFT and Concern Significant Others, run by Kjeld Andersen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether the drinker has sought treatment for her/his alcohol use disorder (time frame: 3 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03281057, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.