Alcohol DependenceCRAFTNCT02112396
Community Reinforcement and Family Training (CRAFT) for Treatment-resistant Individuals With Alcohol Use Disorders
A study testing Community Reinforcement and Family Training in people with Alcohol Dependence and Alcohol Abuse, run by University of Luebeck at 1 site in Germany.
Trial summary
The present study examines the efficacy of the Community Reinforcement and Family Training (CRAFT) for Concerned Significant Others (CSOs) of individuals with alcohol use disorders (AUDs) using a randomized waiting list (WL) control group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Dependence, Alcohol Abuse
- What is being tested?
- Community Reinforcement and Family Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2008to Jun 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CSOs of individuals with an AUD according to the Diagnostic and Statistical Manual (DSM-IV) or the International Classification of Diseases (ICD-10)
- At least 18 years old
- At least 15 hours of contact per week to the addicted individual
Who cannot join
- History of severe domestic violence
- Current diagnosis of drug- or alcohol dependence of CSO
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial Intervention for Relatives of Individuals Suffering From Chronic Alcohol Dependence
The present study examines the efficacy of the Community Reinforcement and Family Training (CRAFT) for Concerned Significant Others (CSOs) of individuals with alcohol use disorders (AUDs) using a randomized waiting list (WL) control group. It is hypothesized that after the Intervention group has received CRAFT and prior to the WL- group having received CRAFT, treatment utilization of individuals with AUDs are substantially elevated in the Intervention group.
Read the detailed description
CRAFT is an evidence-based intervention aiming to promote treatment entry by treatment refusing individuals suffering from addiction by coaching their Concerned Significant others (e.g., family members). The intervention is based on diverse elements such as communication training, contingency management, functional analysis of problem behaviors and strategies to improve the live of CSOs and aims to rearrange contingencies in the natural environment of the drinkers so that clean behavior is reinforced and drinking behavior is effectively discouraged. The intervention was developed for adult CSOs and usually consists of up to 12 weekly face-to-face sessions with a duration of one hour each.
- Conditions
- Alcohol Dependence, Alcohol Abuse
- Being tested
- Community Reinforcement and Family Training
- Keywords
- CRAFT, Concerned Significant Others, Contingency management, Reinforcement, Family Intervention
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Reinforcement and Family TrainingBehavioural
The Intervention is based on the CRAFT literature and includes Building and sustaining motivation of CSOs, functional analysis of problem behaviors, domestic violence precautions (if mandatory), improving communication skills of CSOs, use of negative consequences of drinking behavior, positive reinforcement of clean and sober behavior, strategies to enrich CSOs lives, and strategies for inviting the addicted individual to enter treatment.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Subjects receive 12 sessions of Community Reinforcement and Family Training (CRAFT) immediately after study inclusion Receives: Behavioral: Community Reinforcement and Family Training |
| Waiting list group | Other | Waiting list group members receive the Community Reinforcement and Family Training CRAFT intervention after the first follow-up (3 months post study inclusion) Receives: Behavioral: Community Reinforcement and Family Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Utilization of relative with AUD
Treatment utilization rates of the individual holding an AUD were assessed at 3-months follow-up
Measured: 3 months
Secondary outcomes (1)
Mental well-being in participating CSO
Mental health status was assessed using the Beck Depression Inventory (BDI) and the Mental Health Inventory (MHI-5)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startAug 2008
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Hans-Jürgen Rumpf, University of Luebeck
- Investigators
- Hans-Juergen Rumpf, PD Dr., Principal investigator, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112396
- Sponsor's protocol ID
- BMBF-01GX0702
- Other IDs
- 07-210
- Acronym
- CRAFT
- Status last verified
- Apr 2014
- First submitted
- 1 Apr 2014
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Iwen J, Bischof G, Reinhardt S, Grothues J, Hapke U, John U, Freyer-Adam J, Rumpf HJ. The impact of having a loved one with alcohol consumption-related problems on subjective health status and health-risk behaviors in a general hospital sample. Subst Use Misuse. 2010 Dec;45(14):2470-80. doi: 10.3109/10826084.2010.487233. Epub 2010 Jun 10.
PubMed 20536354
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Intervention for Relatives of Individuals Suffering From Chronic Alcohol Dependence
- ClinicalTrials.gov ID
- NCT02112396
- Acronym / sponsor ID
- CRAFT / BMBF-01GX0702
- Conditions
- Alcohol Dependence, Alcohol Abuse
- Keywords
- CRAFT, Concerned Significant Others, Contingency management, Reinforcement, Family Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Aug 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Apr 2014 (estimated)
- 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 examines the efficacy of the Community Reinforcement and Family Training (CRAFT) for Concerned Significant Others (CSOs) of individuals with alcohol use disorders (AUDs) using a randomized waiting list (WL) control group. It is hypothesized that after the Intervention group has received CRAFT and prior to the WL- group having received CRAFT, treatment utilization of individuals with AUDs are substantially elevated in the Intervention group.
Detailed description
CRAFT is an evidence-based intervention aiming to promote treatment entry by treatment refusing individuals suffering from addiction by coaching their Concerned Significant others (e.g., family members). The intervention is based on diverse elements such as communication training, contingency management, functional analysis of problem behaviors and strategies to improve the live of CSOs and aims to rearrange contingencies in the natural environment of the drinkers so that clean behavior is reinforced and drinking behavior is effectively discouraged. The intervention was developed for adult CSOs and usually consists of up to 12 weekly face-to-face sessions with a duration of one hour each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Community Reinforcement and Family TrainingSubjects receive 12 sessions of Community Reinforcement and Family Training (CRAFT) immediately after study inclusion |
| Waiting list group | Other | Behavioral: Community Reinforcement and Family TrainingWaiting list group members receive the Community Reinforcement and Family Training CRAFT intervention after the first follow-up (3 months post study inclusion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CSOs of individuals with an AUD according to the Diagnostic and Statistical Manual (DSM-IV) or the International Classification of Diseases (ICD-10)
- At least 18 years old
- At least 15 hours of contact per week to the addicted individual
Key exclusion criteria (2 listed)
- History of severe domestic violence
- Current diagnosis of drug- or alcohol dependence of CSO
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 |
|---|---|---|
| Community Reinforcement and Family TrainingThe Intervention is based on the CRAFT literature and includes Building and sustaining motivation of CSOs, functional analysis of problem behaviors, domestic violence precautions (if mandatory), improving communication skills of CSOs, use of negative consequences of drinking behavior, positive reinforcement of clean and sober behavior, strategies to enrich CSOs lives, and strategies for inviting the addicted individual to enter treatment. | Behavioural | Immediate Intervention, Waiting list group |
Primary outcome
Treatment Utilization of relative with AUD
Time frame: 3 months
Treatment utilization rates of the individual holding an AUD were assessed at 3-months follow-up
1 secondary outcome
Mental well-being in participating CSO
Time frame: 3 months
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 14 Apr 2014.
- Background: PubMed 20536354Iwen J, Bischof G, Reinhardt S, Grothues J, Hapke U, John U, Freyer-Adam J, Rumpf HJ. The impact of having a loved one with alcohol consumption-related problems on subjective health status and health-risk behaviors in a general hospital sample. Subst Use Misuse. 2010 Dec;45(14):2470-80. doi: 10.3109/10826084.2010.487233. Epub 2010 Jun 10.
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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.
Hans-Juergen Rumpf, PD Dr. principal investigator
University of Luebeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Reinforcement and Family Training in people with Alcohol Dependence and Alcohol Abuse, run by University of Luebeck at 1 site in Germany.
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 3 inclusion and 2 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 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Treatment Utilization of relative with AUD (time frame: 3 months). 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 NCT02112396, which also lists 1 linked publication.
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 14 Apr 2014.