<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/NCT01707576</url>
  </required_header>
  <id_info>
    <org_study_id>P090103</org_study_id>
    <nct_id>NCT01707576</nct_id>
  </id_info>
  <brief_title>Screening of Adolescent Mental Suffering</brief_title>
  <acronym>DESPERADOS</acronym>
  <official_title>SCREENING OF ADOLESCENT MENTAL SUFFERING CONSULTANT TO EMERGENCIES, MANAGEMENT AND Later MONITORING</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fondation de France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose is to estimate the prevalence of depression and subsyndromal states among&#xD;
      adolescents 13 to 17 years consulting to hospital emergency rooms for any reason, for they&#xD;
      are another way of tracking this suffering, as they host many troubled teens at once for&#xD;
      health problems and accidents sometimes iterative, reflecting their risk behaviour.&#xD;
&#xD;
      Secondary purposes are to assess the feasibility and desirability of a post-emergency medical&#xD;
      consultation for adolescents who scored high on a self-administered questionnaire, and to&#xD;
      assess the impact of this approach by later monitoring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter longitudinal survey in three emergency centers in Ile-de-France, with 2&#xD;
      periods of daily collection and comprehensive three weeks spread over one year, followed by a&#xD;
      remote evaluation.&#xD;
&#xD;
      The project is as follows:&#xD;
&#xD;
      Phase A :&#xD;
&#xD;
      - Evaluation of the prevalence: systematic execution of self-administered questionnaire by&#xD;
      all adolescents consulting, night and day in each center.&#xD;
&#xD;
      Phase B :&#xD;
&#xD;
        -  For adolescents whose outcome questionnaire exceed 4, a post-emergency consultation will&#xD;
           be proposed within 15 days.&#xD;
&#xD;
        -  Telephone survey, 12 months after the passage of emergency every teenager who completed&#xD;
           self-administered questionnaire and presenting himself to the post-emergency&#xD;
           consultation. This survey will aim to assess the psychological status of adolescents and&#xD;
           the impact of any specific treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2010</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Responses to Self-reported questionnaire on risk behaviors, somatic complaints by adolescents and parents</measure>
    <time_frame>10 months</time_frame>
    <description>A self-questionnaire ADRS (Adolescent Depression Rating Scale) will be asked to all adolescents to complete. Also the other questions will be answered by them concenrning somatisations and risk behaviors. Parents respond in the same time a self questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-emergency consultation and reassessment of hetero-ADRS clinician questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>Actual presence of adolescents suspected of depression at the post-emergency consultation and reassessment of their state using the hetero-ADRS-clinician questionnaire.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Revaluation after one year</measure>
    <time_frame>6 months</time_frame>
    <description>Revaluation after 1 year of the teenagers who come back to visit.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">346</enrollment>
  <condition>Depression</condition>
  <condition>Adolescent</condition>
  <condition>Self-report Questionnaire</condition>
  <arm_group>
    <arm_group_label>screening of adolescent mental suffering. Management</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>screening of adolescent mental suffering consultant to emergencies. Management and later monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>consultation 10 days later</intervention_name>
    <description>new depression screening</description>
    <arm_group_label>screening of adolescent mental suffering. Management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents over the age of 13 to 17 years when passing emergency whatever the reason&#xD;
             for consultation (surgical or medical, including attempted suicide or psychological&#xD;
             problem)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Young people not reading French.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chantal Stheneur, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ambroise Paré University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of paediatric emergencies, Ambroise Paré universitary hospital</name>
      <address>
        <city>Boulogne Billancourt</city>
        <state>Ile de France</state>
        <zip>92100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2010</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>April 1, 2016</last_update_submitted>
  <last_update_submitted_qc>April 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Follow-Up Studies</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Depressive Disorder, Major/diagnosis</keyword>
  <keyword>Attempted/prevention &amp; control</keyword>
  <keyword>Self-report questionnaire</keyword>
  <keyword>emmergency department</keyword>
  <keyword>parental perception</keyword>
  <keyword>Emergency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT01707576
org study id: P090103
nct id: NCT01707576
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The primary purpose is to estimate the prevalence of depression and subsyndromal states among
      adolescents 13 to 17 years consulting to hospital emergency rooms for any reason, for they
      are another way of tracking this suffering, as they host many troubled teens at once for
      health problems and accidents sometimes iterative, reflecting their risk behaviour.

      Secondary purposes are to assess the feasibility and desirability of a post-emergency medical
      consultation for adolescents who scored high on a self-administered questionnaire, and to
      assess the impact of this approach by later monitoring.
This is a multicenter longitudinal survey in three emergency centers in Ile-de-France, with 2
      periods of daily collection and comprehensive three weeks spread over one year, followed by a
      remote evaluation.

      The project is as follows:

      Phase A :

      - Evaluation of the prevalence: systematic execution of self-administered questionnaire by
      all adolescents consulting, night and day in each center.

      Phase B :

        -  For adolescents whose outcome questionnaire exceed 4, a post-emergency consultation will
           be proposed within 15 days.

        -  Telephone survey, 12 months after the passage of emergency every teenager who completed
           self-administered questionnaire and presenting himself to the post-emergency
           consultation. This survey will aim to assess the psychological status of adolescents and
           the impact of any specific treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Responses to Self-reported questionnaire on risk behaviors, somatic complaints by adolescents and parents
time frame: 10 months
description: A self-questionnaire ADRS (Adolescent Depression Rating Scale) will be asked to all adolescents to complete. Also the other questions will be answered by them concenrning somatisations and risk behaviors. Parents respond in the same time a self questionnaire.
measure: Post-emergency consultation and reassessment of hetero-ADRS clinician questionnaire
time frame: 6 months
description: Actual presence of adolescents suspected of depression at the post-emergency consultation and reassessment of their state using the hetero-ADRS-clinician questionnaire.
measure: Revaluation after one year
time frame: 6 months
description: Revaluation after 1 year of the teenagers who come back to visit.
arm group label: screening of adolescent mental suffering. Management
arm group type: Other
description: screening of adolescent mental suffering consultant to emergencies. Management and later monitoring
intervention type: Behavioral
intervention name: consultation 10 days later
description: new depression screening
arm group label: screening of adolescent mental suffering. Management
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: No
last name: Chantal Stheneur, MD
role: Principal Investigator
affiliation: Ambroise Paré University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Depression