- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01692054
Risk and Protective Factors of Children and Adolescents Who Were Hospitalized Due to Alcohol Intoxication (RiScA)
May 20, 2014 updated by: Technische Universität Dresden
Prediction and Detection of Intermediate and Long-term Developmental Hazards in Adolescents After Alcohol Intoxication
The aim of the study is to improve the prognosis of the development of alcohol consumption by considering a variety of biological, psychological and social risk and protective factors.
Therefore, young people who have been hospitalized due to acute alcohol intoxication within the past 5 to 12 years will be interviewed in order to assess aspects of healthy or impaired psychosocial development.
The study will also include a control group of young adults who were in hospital due to other medical conditions.
The identification of relevant cases will be based on medical records of several children's hospitals.
These records will be analysed with regard to potential predictors of developmental hazards and protective factors.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
394
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
-
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Saxony
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Dresden, Saxony, Germany, 01307
- Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
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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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
young adults living in Germany who were hospitalized due to alcohol intoxication (experimental group) or other medical conditions (control group) 5 to 12 years ago
Description
experimental group:
Inclusion Criteria:
- male and female volunteers who were hospitalized due to acute alcohol intoxication from January 1, 2000 to December 31, 2006
- written informed consent by the subject
- minimum age of 20 years
Exclusion Criteria:
- incapability to conduct interview
control group:
Inclusion Criteria:
- male and female volunteers who were hospitalized due to other medical conditions but not acute alcohol intoxication from January 1, 2000 to December 31, 2006
- written informed consent by the subject
- minimum age of 20 years
Exclusion Criteria:
- incapability to conduct interview
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
Cohorts and Interventions
Group / Cohort |
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Alcohol intoxicated adolescents
Adolescents who were hospitalized due to acute alcohol intoxication
|
Control group
adolescents who were hospitalized due to other medical conditions but not alcohol intoxication
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Use Disorders
Time Frame: 5 to 13 years
|
Alcohol Use Disorders as measured by the The Alcohol Use Disorders Identification Test
|
5 to 13 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-efficacy
Time Frame: 5 to 13 years
|
5 to 13 years
|
Life Satisfaction
Time Frame: 5 to 13 years
|
5 to 13 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ulrich Zimmermann, Dr, Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
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
June 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
August 21, 2012
First Submitted That Met QC Criteria
September 21, 2012
First Posted (Estimate)
September 25, 2012
Study Record Updates
Last Update Posted (Estimate)
May 21, 2014
Last Update Submitted That Met QC Criteria
May 20, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIA5-2511DSM220
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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