- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01416103
Alcohol and Employment
Alcohol and Employment - a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and purpose: The Tryg Foundation Denmark has awarded funds for a study that tests how to most efficiently combine welfare-to-work schemes with efforts against alcoholism, in relation to a return to the labour market.
The study will be carried out in a number of Danish municipalities in the time frame 2011-2014.
The purpose of the study is to determine whether a welfare-to-work scheme combined with alcohol treatment is more efficient than a welfare-to-work scheme alone, for unemployed citizens with alcohol problems.
Design: If the welfare recipient meets the inclusion criteria, then the recipient is provided with information about the project by the caseworker. If the recipient wishes to participate in the project he/she is asked to fill out a consent form and a questionnaire regarding employment status, alcohol consumption, other habits of abuse, health status and background information.
Welfare recipients who do not wish to participate will as usual be referred to the welfare-to-work schemes deemed most appropriate by the caseworker.
The intervention is designed as a randomized controlled trial, where heavy drinkers who meet the inclusion criteria and wish to participate will be allocated to either:
A) An intervention group receiving welfare-to-work scheme combined with alcohol treatment.
or
B) A control group receiving only welfare-to-work scheme.
After 6 and 12 months there will be a follow-up where participants will be asked to answer a questionnaire with questions about their employment status, alcohol consumption, other habits of abuse, health status and background information.
In this study ANCOVA is chosen to analyses the effective of the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Copenhagen K
-
Copenhagen, Copenhagen K, Denmark, 1353
- National Institute of Public Health - University of Southern Denmark
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants must have an audit-score above 7.
- Participants must be unemployed and receive welfare-to-work schemes when included.
Exclusion Criteria:
- Participants who have an audit-score below 8.
- Participants who have a normal job.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
|
Alcohol treatment paralleling welfare-to-work participation: The participants are referred to the municipalities' outpatient alcohol treatment programmes and at the same time referred to an ordinary welfare-to-work programme.
|
Placebo Comparator: Intervention control
Control group
|
The participants will as usual be referred to the welfare-to-work schemes deemed most appropriate by the caseworker.
The intervention is no different than what the municipality would have offered if the participant was not part of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in the participant's employment status at 6 and 12 months.
Time Frame: 6 and 12 months
|
Change in the participant's employment status, i.e. a) ordinary job, b) change in the participant transfer payments or in other ways approaching the labour market. Employment status is measured with self-reported questionnaires and with a number of administrative registers connected through each participant's personal identification number. |
6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in the participant's alcohol consumption, health status and readiness for the labour market at 6 and 12 months.
Time Frame: 6 and 12 months
|
|
6 and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Morten Grønbæk, MD, PhD, Centre for Intervention Research in HEalth Promotion and Disease Prevention
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 61110- 1986 (tryg, p7)
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.
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