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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02112396
Other study ID # BMBF-01GX0702
Secondary ID 07-210
Status Completed
Phase N/A
First received April 1, 2014
Last updated April 9, 2014
Start date August 2008
Est. completion date June 2011

Study information

Verified date April 2014
Source University of Luebeck
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date June 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Community Reinforcement and Family Training
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.

Locations

Country Name City State
Germany University of Luebeck Luebeck Schl.-Holstein

Sponsors (2)

Lead Sponsor Collaborator
University of Luebeck German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Drinking behavior of relative with AUD Drinking behavior assessed by the AUDIT-C 3 months No
Primary Treatment Utilization of relative with AUD Treatment utilization rates of the individual holding an AUD were assessed at 3-months follow-up 3 months No
Secondary Mental well-being in participating CSO Mental health status was assessed using the Beck Depression Inventory (BDI) and the Mental Health Inventory (MHI-5) 3 months No
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