<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/NCT04475484</url>
  </required_header>
  <id_info>
    <org_study_id>PSICOcs_2020</org_study_id>
    <nct_id>NCT04475484</nct_id>
  </id_info>
  <brief_title>Online Survey on Psychological Impact of COVID-19 Epidemic on School-age Children</brief_title>
  <acronym>PSICOcs</acronym>
  <official_title>Online Survey on Psychological Impact of COVID-19 Epidemic on School-age Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The coronavirus outbreak is a stressful event for the whole population. Confinement measures&#xD;
      are protective against the risk of dissemination of the virus, but they can also lead to&#xD;
      several psychological symptoms. In children, a study in China has reported about 20% of&#xD;
      depressive or anxious troubles in school-age children after a 4-week period of confinement.&#xD;
&#xD;
      In France, confinement lasted about 8 weeks. School resumed on May 11th for primary school&#xD;
      children and on June 2nd for secondary school children.&#xD;
&#xD;
      In this survey, we aim at exploring the psychological status of these children and the impact&#xD;
      on their schooling, for better understanding, support and prevention. Through this online&#xD;
      questionnaire, we also aim at giving some psycho-education advices. Finally, we could&#xD;
      identify some subgroups of children particularly vulnerable, and organise some specific&#xD;
      support for them in coming months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of children presenting signs of psychological suffering during confinement.</measure>
    <time_frame>We plan to address a first online questionnaire in June 2020 (school resumption after confinement), and a follow-up questionnaire 3 months later, in September 2020.</time_frame>
    <description>We plan to assess the psychological status of children during coronavirus outbreak : negative and positive feeling during confinement, worries and expectations about school resumption.&#xD;
We also aim at correlating high stress levels with environmental or/and temperamental factors.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30000</enrollment>
  <condition>Investigating Psychological Impact</condition>
  <condition>Confinement Measures</condition>
  <condition>Coronavirus Outbreak</condition>
  <condition>School-age Children</condition>
  <arm_group>
    <arm_group_label>School-age children</arm_group_label>
    <description>School-age children from primary school to high school (about age 6 to 18) in the Academy of Lyon</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Online questionnaire</intervention_name>
    <description>Parents will receive a link to an online questionnaire through computing services of Lyon's Academy. They have to give their consent to allow their child to participate in the study. Then, children can complete the online questionnaire.&#xD;
The questionnaire starts with few explanations on the context of the study, and ends with psycho-education advices and what to do in the event of psychological distress.</description>
    <arm_group_label>School-age children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        School-age children from primary school to high school (about age 6 to 18) in the Academy&#xD;
        of Lyon&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  school-age children in the Academy of Lyon&#xD;
&#xD;
          -  parental consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Pauline Espi</last_name>
    <phone>4 72 12 95 62</phone>
    <phone_ext>+33</phone_ext>
    <email>pauline.espi@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pierre Pierre Fourneret</last_name>
    <phone>4 72 12 95 62</phone>
    <phone_ext>+33</phone_ext>
    <email>pierre.fourneret@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>hôpital Femme Mère Enfant</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pauline Espi</last_name>
      <phone>4 72 12 95 62</phone>
      <phone_ext>+33</phone_ext>
      <email>pauline.espi@chu-lyon.fr</email>
    </contact>
    <contact_backup>
      <last_name>Pierre Fourneret</last_name>
      <phone>4 72 12 95 62</phone>
      <phone_ext>+33</phone_ext>
      <email>pierre.fourneret@chu-lyon.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>coronavirus epidemic</keyword>
  <keyword>Children</keyword>
  <keyword>Schooling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</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/NCT04475484
org study id: PSICOcs_2020
nct id: NCT04475484
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The coronavirus outbreak is a stressful event for the whole population. Confinement measures
      are protective against the risk of dissemination of the virus, but they can also lead to
      several psychological symptoms. In children, a study in China has reported about 20% of
      depressive or anxious troubles in school-age children after a 4-week period of confinement.

      In France, confinement lasted about 8 weeks. School resumed on May 11th for primary school
      children and on June 2nd for secondary school children.

      In this survey, we aim at exploring the psychological status of these children and the impact
      on their schooling, for better understanding, support and prevention. Through this online
      questionnaire, we also aim at giving some psycho-education advices. Finally, we could
      identify some subgroups of children particularly vulnerable, and organise some specific
      support for them in coming months.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Proportion of children presenting signs of psychological suffering during confinement.
time frame: We plan to address a first online questionnaire in June 2020 (school resumption after confinement), and a follow-up questionnaire 3 months later, in September 2020.
description: We plan to assess the psychological status of children during coronavirus outbreak : negative and positive feeling during confinement, worries and expectations about school resumption.
We also aim at correlating high stress levels with environmental or/and temperamental factors.
arm group label: School-age children
description: School-age children from primary school to high school (about age 6 to 18) in the Academy of Lyon
intervention type: Other
intervention name: Online questionnaire
description: Parents will receive a link to an online questionnaire through computing services of Lyon's Academy. They have to give their consent to allow their child to participate in the study. Then, children can complete the online questionnaire.
The questionnaire starts with few explanations on the context of the study, and ends with psycho-education advices and what to do in the event of psychological distress.
arm group label: School-age children
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pauline Espi
phone: 4 72 12 95 62
phone ext: +33
email: pauline.espi@chu-lyon.fr
last name: Pierre Pierre Fourneret
phone: 4 72 12 95 62
phone ext: +33
email: pierre.fourneret@chu-lyon.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Coronavirus Infections