Alcohol Use DisordersRiScANCT01692054
Risk and Protective Factors of Children and Adolescents Who Were Hospitalized Due to Alcohol Intoxication
An observational study of Alcohol Use Disorders, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Alcohol Use Disorders
- How many people
- 394 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
- 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
Who cannot join
- incapability to conduct interview
- control group:
- incapability to conduct interview
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
Dresden, Saxony, 01307
About this study
Official title: 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.
- Conditions
- Alcohol Use Disorders
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use Disorders
Alcohol Use Disorders as measured by the The Alcohol Use Disorders Identification Test
Measured: 5 to 13 years
Secondary outcomes (2)
Self-efficacy
Measured: 5 to 13 years
Life Satisfaction
Measured: 5 to 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisordersStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrich Zimmermann, Dr, Principal investigator, Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692054
- Sponsor's protocol ID
- IIA5-2511DSM220
- Acronym
- RiScA
- Status last verified
- May 2014
- First submitted
- 21 Aug 2012
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Detection of Intermediate and Long-term Developmental Hazards in Adolescents After Alcohol Intoxication
- ClinicalTrials.gov ID
- NCT01692054
- Acronym / sponsor ID
- RiScA / IIA5-2511DSM220
- Conditions
- Alcohol Use Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
- 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
Key exclusion criteria (3 listed)
- incapability to conduct interview
- incapability to conduct interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alcohol Use Disorders
Time frame: 5 to 13 years
Alcohol Use Disorders as measured by the The Alcohol Use Disorders Identification Test
2 secondary outcomes
Self-efficacy
Time frame: 5 to 13 years
Life Satisfaction
Time frame: 5 to 13 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Zimmermann, Dr principal investigator
Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorders, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use Disorders (time frame: 5 to 13 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2014; AzTrials last refreshed its copy on 8 Nov 2026.