- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03097354
Assignment of Alcohol Drinks to CIDI Drink Categories (AF-CIDI)
Validation of the Assignment of Alcoholic Drinks to Predefined Drink Groups in the Composite International Diagnostic Interview (CIDI)
Alcohol consumption is a prevalent behavior in Western societies, which may produce feelings of happiness and sociability, but also increases the risk of individual and societal detriments. A detailed knowledge about individual and region-specific alcohol consumption is crucial in many aspects of health systems, from general practitioner's diagnostic evaluation to decisions on health-care related fundings for prevention programs by legislative and executive councils.
The assessment of alcohol consumption often consists of questions like "What alcohol and in which amount did you drink lately?" which may be answered using a given list of prevalent alcoholic beverages. With this study, the investigators want to contribute to the understanding of psychological determinants in answering these questions. For example, it is not yet fully understood, to which extend and why certain beverages are assigned to one of several beverage groups. The investigators suspect that familiarity with specific beverages as well as product names may influence this assignment.
In this online survey, which is open to any German-speaking alcohol user no matter how often or how much alcohol one normally consumes, participants will be presented a list of common beverages (e.g. Cuba Libre, Prosecco, Weizen) and asked to assign these beverages to one of several beverage groups (e.g. whiskey, beer, sparkling wine).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators expect that alcohol users will assign alcoholic drinks based on the product names, which might lead to erroneous assignments to predefined drink groups in certain occasions (e.g. "Bierlikör - beer liquor"). Furthermore, it is hypothesized that this tendency is smaller the more familiar a user is with the drink. Lastly, it is hypothesized that drinks with relatively low use prevalence in the general population, e.g. sweet liquors and cocktails, and drinks that include alcohol mixed with non-alcoholic beverages (e.g. "Radler", a beer-lemonade mix), are more often subject to non-concordant assignment across participants compared to highly-prevalent drinks (e.g. "Pilsner").
Thus, the investigators expect alcohol users to:
- assign >90% of the presented beverages correctly,
- differ from the expert assignments especially in drinks they are not familiar with,
- differ from the expert assignments especially in drinks with ambiguous names,
- do not differ in their assignments based on their gender and age group.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Dresden, Germany, 01187
- Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Lifetime-consumption of any of the 60 presented alcoholic beverages,
- Consumption of 12 or more alcoholic drinks past year,
- Ability to understand and accept the informed consent, to answer the presented questions and fill out all questionnaires
Exclusion Criteria:
- Multiple participation in this study
- not answering at least one presented questionnaire (60-beverages-questionnaire, assignment-questionnaire, AUDIT questionnaire, sociodemographic questionnaire)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Non-students
Ad-hoc sample of German adults, not currently enrolled at a university, lifetime alcohol users, no intervention/observational survey study design
|
no intervention/observational survey study design
|
University students
Ad-hoc sample of German adults, currently enrolled at a university (most likely in Dresden, Germany), lifetime alcohol users, no intervention/observational survey study design
|
no intervention/observational survey study design
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beverage assignment
Time Frame: at the baseline survey
|
Actual correctness of beverage assignment for each beverage (max.
60 beverages), either correct or incorrect
|
at the baseline survey
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confidence
Time Frame: at the baseline survey
|
Self-report of confidence in the specific beverage assignment (Answer categories: sure; medium; barely)
|
at the baseline survey
|
Familiarity
Time Frame: at the baseline survey
|
Self-report of familiarity with the specific drink type (Answer categories: frequently consumed (>3 times); tried (1-3 times)
|
at the baseline survey
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Socio-demographics
Time Frame: at the baseline survey
|
Gender, year of birth, German state/region, nationality, relationship status, education level, employment status,
|
at the baseline survey
|
Risk status for Alcohol Use Disorder
Time Frame: at the baseline survey
|
Sum score of the 10-item AUDIT screening of the World Health Organization
|
at the baseline survey
|
Risky alcohol consumption
Time Frame: at the baseline survey
|
Sum score of the first three AUDIT items, i.e.
AUDIT-C score
|
at the baseline survey
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sören Kuitunen-Paul, Technische Universitat Dresden
Publications and helpful links
General Publications
- Kuitunen-Paul S, Kuitunen PT, Kadrić F, Lachenmeier DW, Čolić J, Leonhardt L, Scheffel C. Assignment of alcoholic beverages in the Munich Composite International Diagnostic Interview (M-CIDI): An online survey among German students and non-students. International Journal of Mental Health and Addiction. 2019;(ePub ahead of print). doi:10.1007/s11469-019-00074-5
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AF-CIDI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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