<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/NCT03301077</url>
  </required_header>
  <id_info>
    <org_study_id>FA765A0303</org_study_id>
    <nct_id>NCT03301077</nct_id>
  </id_info>
  <brief_title>Mental Health in Austrian Teenagers (MHAT)</brief_title>
  <acronym>MHAT</acronym>
  <official_title>The Mental Health in Austrian Teenagers (MHAT) - Study: First Epidemiological Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ludwig Boltzmann Institute Health Promotion Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pharmig - Gesundheitsziele aus dem Rahmen-Pharmavertrag</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the Mental Health in Austrian Teenagers (MHAT) - Study is to collect the first&#xD;
      epidemiological data on mental health and psychiatric disorders in a representative sample of&#xD;
      Austrian adolescents between 10 and 18 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Knowing about the prevalence of psychiatric disorders and related risk and protective factors&#xD;
      is essential for the development of prevention programs and therapeutic approaches. Up to&#xD;
      now, no epidemiological data on prevalence rates of psychiatric disorders and related risk&#xD;
      and protective factors based on a representative sample is available for Austrian&#xD;
      adolescents.&#xD;
&#xD;
      The aim of the study is to present rates of behavioral, emotional and social problems as well&#xD;
      as prevalence rates of mental disorders. Furthermore the investigators want to examine risk&#xD;
      factors, protective factors and quality of life in a large sample of adolescents aged 10 to&#xD;
      18 years. A two step design is chosen for this purpose to obtain diagnoses based on the&#xD;
      Diagnostic and Statistical Manual of the American Psychiatric Association, Version 5 (DSM-5):&#xD;
&#xD;
        1. Phase 1 (screening) is a screening for emotional, behavioral and social problems as well&#xD;
           as social and demographic correlates, risk and protective factors and quality of life.&#xD;
&#xD;
        2. Phase 2 (interviews) includes structured diagnostic interviews to assess psychiatric&#xD;
           diagnoses according to DSM-5 criteria with adolescents above a predefined cut-off score&#xD;
           in the screening, and a random sample of adolescents scoring below the cut-off.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>psychiatric problems (diagnoses based on the Diagnostic and Statistical Manual of the American Psychiatric Association, Version 5 (DSM-5)</measure>
    <time_frame>12 months</time_frame>
    <description>Screening and interview</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rates of behavioral, emotional and social problems (representation of data collected at interview)</measure>
    <time_frame>12 months</time_frame>
    <description>YSR (Youth Self Report) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>psychiatric disorder related risks and protective factors (representation of data collected at interviews)</measure>
    <time_frame>12 months</time_frame>
    <description>Kinder-DIPS (Diagnostisches Interview psychischer Störungen) interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life (total score, self-perception, parent relation &amp; home life, social support &amp; peers, school environment and bullying)</measure>
    <time_frame>12 months</time_frame>
    <description>KIDSCREEN (Kidscreen) questionnaire</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4000</enrollment>
  <condition>Mental Disorders</condition>
  <arm_group>
    <arm_group_label>General population</arm_group_label>
    <description>recruited from schools and other institutions like job-centers or child and adolescent psychiatries</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>2-phase epidemiological study (screening, interviews)</intervention_name>
    <description>first phase is the screening phase, second phase is the interview phase</description>
    <arm_group_label>General population</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        general population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adolescents aged 10-18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no written informed consent possible due to intelligence or no willingness by parents&#xD;
             to include minor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Karwautz, MD, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Medical University Vienna</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wolfgang Dür, Phd, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Ludwig Boltzmann Institute LBIHPR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna, Dep. of Child and Adolescent Psychiatry</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <link>
    <url>http://www.ess-stoerung.eu</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Dr. Andreas Karwautz</investigator_full_name>
    <investigator_title>Univ. Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>children and adolescents</keyword>
  <keyword>mental health</keyword>
  <keyword>epidemiology</keyword>
  <keyword>psychiatric disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</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/NCT03301077
org study id: FA765A0303
nct id: NCT03301077
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of the Mental Health in Austrian Teenagers (MHAT) - Study is to collect the first
      epidemiological data on mental health and psychiatric disorders in a representative sample of
      Austrian adolescents between 10 and 18 years.
Knowing about the prevalence of psychiatric disorders and related risk and protective factors
      is essential for the development of prevention programs and therapeutic approaches. Up to
      now, no epidemiological data on prevalence rates of psychiatric disorders and related risk
      and protective factors based on a representative sample is available for Austrian
      adolescents.

      The aim of the study is to present rates of behavioral, emotional and social problems as well
      as prevalence rates of mental disorders. Furthermore the investigators want to examine risk
      factors, protective factors and quality of life in a large sample of adolescents aged 10 to
      18 years. A two step design is chosen for this purpose to obtain diagnoses based on the
      Diagnostic and Statistical Manual of the American Psychiatric Association, Version 5 (DSM-5):

        1. Phase 1 (screening) is a screening for emotional, behavioral and social problems as well
           as social and demographic correlates, risk and protective factors and quality of life.

        2. Phase 2 (interviews) includes structured diagnostic interviews to assess psychiatric
           diagnoses according to DSM-5 criteria with adolescents above a predefined cut-off score
           in the screening, and a random sample of adolescents scoring below the cut-off.
observational model: Other
time perspective: Cross-Sectional
measure: psychiatric problems (diagnoses based on the Diagnostic and Statistical Manual of the American Psychiatric Association, Version 5 (DSM-5)
time frame: 12 months
description: Screening and interview
measure: rates of behavioral, emotional and social problems (representation of data collected at interview)
time frame: 12 months
description: YSR (Youth Self Report) questionnaire
measure: psychiatric disorder related risks and protective factors (representation of data collected at interviews)
time frame: 12 months
description: Kinder-DIPS (Diagnostisches Interview psychischer Störungen) interview
measure: quality of life (total score, self-perception, parent relation & home life, social support & peers, school environment and bullying)
time frame: 12 months
description: KIDSCREEN (Kidscreen) questionnaire
arm group label: General population
description: recruited from schools and other institutions like job-centers or child and adolescent psychiatries
intervention type: Other
intervention name: 2-phase epidemiological study (screening, interviews)
description: first phase is the screening phase, second phase is the interview phase
arm group label: General population
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andreas Karwautz, MD, Prof
role: Study Director
affiliation: Medical University Vienna
last name: Wolfgang Dür, Phd, Prof
role: Study Director
affiliation: Ludwig Boltzmann Institute LBIHPR
facility: 
country: Austria
url: http://www.ess-stoerung.eu
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Dr. Andreas Karwautz
investigator title: Univ. Prof. Dr.
mesh term: Mental Disorders