- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02112396
Community Reinforcement and Family Training (CRAFT) for Treatment-resistant Individuals With Alcohol Use Disorders (CRAFT)
April 9, 2014 updated by: Hans-Jürgen Rumpf, University of Luebeck
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Schl.-Holstein
-
Luebeck, Schl.-Holstein, Germany, 23538
- University of Luebeck
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of severe domestic violence
- Current diagnosis of drug- or alcohol dependence of CSO
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Intervention
Subjects receive 12 sessions of Community Reinforcement and Family Training (CRAFT) immediately after study inclusion
|
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.
|
Other: Waiting list group
Waiting list group members receive the Community Reinforcement and Family Training CRAFT intervention after the first follow-up (3 months post study inclusion)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental well-being in participating CSO
Time Frame: 3 months
|
Mental health status was assessed using the Beck Depression Inventory (BDI) and the Mental Health Inventory (MHI-5)
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drinking behavior of relative with AUD
Time Frame: 3 months
|
Drinking behavior assessed by the AUDIT-C
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Hans-Juergen Rumpf, PD Dr., University of Luebeck
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
April 1, 2014
First Submitted That Met QC Criteria
April 9, 2014
First Posted (Estimate)
April 14, 2014
Study Record Updates
Last Update Posted (Estimate)
April 14, 2014
Last Update Submitted That Met QC Criteria
April 9, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMBF-01GX0702
- 07-210 (Other Identifier: University of Luebeck, Ethics Committee)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Dependence
-
University Hospital, LilleCompleted
-
Tel-Aviv Sourasky Medical CenterMinistry of Health, IsraelUnknownAlcohol-dependenceIsrael
-
Pop Test Oncology LLCBaylor College of Medicine; Michael E. DeBakey VA Medical Center; Congressionally... and other collaboratorsCompletedPotential Treatment for Alcohol Dependence-Alcohol InteractionUnited States
-
DynamiCare HealthNational Institute on Alcohol Abuse and Alcoholism (NIAAA); RANDActive, not recruitingAlcohol Dependence | Alcohol Use Disorder | Drug DependenceUnited States
-
National Institute on Alcohol Abuse and Alcoholism...CompletedAlcohol Abuse | Alcohol Dependence (Primary Condition)United States
-
University Hospital, Gentofte, CopenhagenCompleted
-
Massachusetts General HospitalCompletedAlcohol Dependence | Drug Abuse | Alcohol Abuse | Drug DependenceUnited States
-
Psychiatric Centre RigshospitaletThe Novavì outpatient clinics, CopenhagenRecruitingAddiction, Alcohol | Alcohol Dependence, in RemissionDenmark
-
University of WashingtonU.S. Army Medical Research and Development CommandCompletedAlcohol Dependence | Substance Abuse | Alcohol Abuse | Substance DependenceUnited States
-
Anders Fink-Jensen, MD, DMSciThe Novavì outpatient clinics, Copenhagen; Neurobiology Research Unit, Rigshospitalet... and other collaboratorsCompletedAddiction, Alcohol | Alcohol Dependence, in RemissionDenmark
Clinical Trials on Community Reinforcement and Family Training
-
Centre for Addiction and Mental HealthMclean HospitalCompletedSchizophrenia Spectrum and Other Psychotic Disorders | Substance Use | Substance Use Disorders | Psychosis | Schizophrenia and Related DisordersCanada
-
Treatment Research InstituteNational Institute on Drug Abuse (NIDA); Robert J. Meyers PhD & AssociatesCompletedSubstance-Related Disorders | Substance Abuse | Drug AddictionUnited States
-
We The Village, Inc.National Institute on Drug Abuse (NIDA); Public Health Management CorporationRecruitingSubstance-Related Disorders | Family Health | Community Reinforcement And Family TrainingUnited States
-
We The Village, Inc.Public Health Management CorporationCompletedSubstance-Related Disorders | Family Health | Community Reinforcement And Family TrainingUnited States
-
Oregon Research InstituteCompletedSubstance Use Disorders | Treatment RefusalUnited States
-
Mclean HospitalNational Institute on Drug Abuse (NIDA)RecruitingSchizophrenia | Schizoaffective Disorder | Bipolar Disorder | Cannabis | Substance Use | Substance Use Disorders | Psychosis | Mental Disorder | Family | Marijuana | AlcoholUnited States
-
Stanford UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Southern... and other collaboratorsRecruitingAlcohol Drinking | Alcohol Use Disorder | Alcohol Abuse | Military Family | Relations, InterpersonalUnited States
-
Colchester East Hants Health AuthorityUniversity of Calgary; Dalhousie University; Pictou County Health AuthorityWithdrawnPathological GamblingCanada
-
Treatment Research InstituteCompletedAlcohol Dependence | Substance Abuse | Drug Addiction | Opiate Dependence | Stimulant DependenceUnited States
-
International Islamic University, IslamabadPakistan Institute of Living and LearningActive, not recruitingCannabis DependencePakistan