Back to resultsCommunity Reinforcement and Family Training (CRAFT) for Treatment-resistant Individuals With Alcohol Use Disorders (CRAFT)
Primary Purpose
Alcohol Dependence, Alcohol Abuse
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Community Reinforcement and Family Training
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring CRAFT, Concerned Significant Others, Contingency management, Reinforcement, Family Intervention
Eligibility Criteria
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
Sites / Locations
- University of Luebeck
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Immediate Intervention
Waiting list group
Arm Description
Subjects receive 12 sessions of Community Reinforcement and Family Training (CRAFT) immediately after study inclusion
Waiting list group members receive the Community Reinforcement and Family Training CRAFT intervention after the first follow-up (3 months post study inclusion)
Outcomes
Primary Outcome Measures
Treatment Utilization of relative with AUD
Treatment utilization rates of the individual holding an AUD were assessed at 3-months follow-up
Secondary Outcome Measures
Mental well-being in participating CSO
Mental health status was assessed using the Beck Depression Inventory (BDI) and the Mental Health Inventory (MHI-5)
Full Information
NCT ID
NCT02112396
First Posted
April 1, 2014
Last Updated
April 9, 2014
Sponsor
University of Luebeck
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT02112396
Brief Title
Community Reinforcement and Family Training (CRAFT) for Treatment-resistant Individuals With Alcohol Use Disorders
Acronym
CRAFT
Official Title
Psychosocial Intervention for Relatives of Individuals Suffering From Chronic Alcohol Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Alcohol Abuse
Keywords
CRAFT, Concerned Significant Others, Contingency management, Reinforcement, Family Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Intervention
Arm Type
Experimental
Arm Description
Subjects receive 12 sessions of Community Reinforcement and Family Training (CRAFT) immediately after study inclusion
Arm Title
Waiting list group
Arm Type
Other
Arm Description
Waiting list group members receive the Community Reinforcement and Family Training CRAFT intervention after the first follow-up (3 months post study inclusion)
Intervention Type
Behavioral
Intervention Name(s)
Community Reinforcement and Family Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Utilization of relative with AUD
Description
Treatment utilization rates of the individual holding an AUD were assessed at 3-months follow-up
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mental well-being in participating CSO
Description
Mental health status was assessed using the Beck Depression Inventory (BDI) and the Mental Health Inventory (MHI-5)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Drinking behavior of relative with AUD
Description
Drinking behavior assessed by the AUDIT-C
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Juergen Rumpf, PD Dr.
Organizational Affiliation
University of Luebeck
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Luebeck
City
Luebeck
State/Province
Schl.-Holstein
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
20536354
Citation
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.
Results Reference
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Community Reinforcement and Family Training (CRAFT) for Treatment-resistant Individuals With Alcohol Use Disorders
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