<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01692054</url>
  </required_header>
  <id_info>
    <org_study_id>IIA5-2511DSM220</org_study_id>
    <nct_id>NCT01692054</nct_id>
  </id_info>
  <brief_title>Risk and Protective Factors of Children and Adolescents Who Were Hospitalized Due to Alcohol Intoxication</brief_title>
  <acronym>RiScA</acronym>
  <official_title>Prediction and Detection of Intermediate and Long-term Developmental Hazards in Adolescents After Alcohol Intoxication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technische Universität Dresden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to improve the prognosis of the development of alcohol consumption by&#xD;
      considering a variety of biological, psychological and social risk and protective factors.&#xD;
      Therefore, young people who have been hospitalized due to acute alcohol intoxication within&#xD;
      the past 5 to 12 years will be interviewed in order to assess aspects of healthy or impaired&#xD;
      psychosocial development. The study will also include a control group of young adults who&#xD;
      were in hospital due to other medical conditions. The identification of relevant cases will&#xD;
      be based on medical records of several children's hospitals. These records will be analysed&#xD;
      with regard to potential predictors of developmental hazards and protective factors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol Use Disorders</measure>
    <time_frame>5 to 13 years</time_frame>
    <description>Alcohol Use Disorders as measured by the The Alcohol Use Disorders Identification Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>5 to 13 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life Satisfaction</measure>
    <time_frame>5 to 13 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">394</enrollment>
  <condition>Alcohol Use Disorders</condition>
  <arm_group>
    <arm_group_label>Alcohol intoxicated adolescents</arm_group_label>
    <description>Adolescents who were hospitalized due to acute alcohol intoxication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>adolescents who were hospitalized due to other medical conditions but not alcohol intoxication</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        young adults living in Germany who were hospitalized due to alcohol intoxication&#xD;
        (experimental group) or other medical conditions (control group) 5 to 12 years ago&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        experimental group:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  male and female volunteers who were hospitalized due to acute alcohol intoxication&#xD;
             from January 1, 2000 to December 31, 2006&#xD;
&#xD;
          -  written informed consent by the subject&#xD;
&#xD;
          -  minimum age of 20 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  incapability to conduct interview&#xD;
&#xD;
        control group:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  male and female volunteers who were hospitalized due to other medical conditions but&#xD;
             not acute alcohol intoxication from January 1, 2000 to December 31, 2006&#xD;
&#xD;
          -  written informed consent by the subject&#xD;
&#xD;
          -  minimum age of 20 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  incapability to conduct interview&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulrich Zimmermann, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden</name>
      <address>
        <city>Dresden</city>
        <state>Saxony</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>May 20, 2014</last_update_submitted>
  <last_update_submitted_qc>May 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcoholic Intoxication</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01692054
org study id: IIA5-2511DSM220
nct id: NCT01692054
lead sponsor: 
has dmc: No
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.
observational model: Case-Control
time perspective: Retrospective
measure: Alcohol Use Disorders
time frame: 5 to 13 years
description: Alcohol Use Disorders as measured by the The Alcohol Use Disorders Identification Test
measure: Self-efficacy
time frame: 5 to 13 years
measure: Life Satisfaction
time frame: 5 to 13 years
arm group label: Alcohol intoxicated adolescents
description: Adolescents who were hospitalized due to acute alcohol intoxication
arm group label: Control group
description: adolescents who were hospitalized due to other medical conditions but not alcohol intoxication
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ulrich Zimmermann, Dr
role: Principal Investigator
affiliation: Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Alcoholic Intoxication