<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/NCT04406558</url>
  </required_header>
  <id_info>
    <org_study_id>COVADO</org_study_id>
    <nct_id>NCT04406558</nct_id>
  </id_info>
  <brief_title>Psychological Impact of the Health Measures Generated by the COVID19 in Adolescents</brief_title>
  <acronym>COVADO</acronym>
  <official_title>Psychological Impact of the Health Measures Generated by the SarsCov-2 Pandemic in Adolescents (COVADO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The lockdown of the French population is a health measure put in place in response to the&#xD;
      pandemic linked to a new coronavirus, SARS-CoV-2 (Covid-19). After a health campaign to&#xD;
      recommend hygienic &quot;barrier gestures&quot; and social distancing, the decision to confine the&#xD;
      population at the national level was decided by the executive from Monday 16 March to Monday&#xD;
      11 May 2020. The national confinement implies the restriction of movement to the strict&#xD;
      necessary, outings near the home and the closure of schools and communities. These decisions&#xD;
      have led to an unprecedented state of stress for the entire French population, the&#xD;
      consequences of which are unknown in the short, medium or long term. The objectives of this&#xD;
      study are to evaluate the psychological impact of the confinement on adolescents with or&#xD;
      without chronic disease and also the difficulties and fears engendered by deconfinement .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">February 27, 2020</completion_date>
  <primary_completion_date type="Actual">January 27, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety score from the Generalized Anxiety Disorder 7 (GAD-7) questionnaire</measure>
    <time_frame>At inclusion</time_frame>
    <description>Scale 0-21</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression score from the Adolescent Depression Rating Scale (ADRS) questionnaire</measure>
    <time_frame>At inclusion</time_frame>
    <description>Scale 0-60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post traumatic score questionnaire: Children's Revised Impact of Events Scales -CRIES13</measure>
    <time_frame>At inclusion</time_frame>
    <description>8 items that are scored on a four-point scale and 3 sub scales: intrusion (4 items); avoidance (4 items) and arousal (5 items)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence or absence of difficulty in falling asleep, sleeping</measure>
    <time_frame>At inclusion</time_frame>
    <description>a question on the quality and quantity of sleep will be asked to the teenager on a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence or absence of feeding difficulty</measure>
    <time_frame>At inclusion</time_frame>
    <description>a question on the presence or absence of feeding difficulty will be asked to the teenager on a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence or absence of difficulty performing physical activity</measure>
    <time_frame>At inclusion</time_frame>
    <description>a question on the presence or absence of difficulty performing physical activity will be asked to the teenager on a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence or absence of toxic consomption (drug, acohol) during the lockdown</measure>
    <time_frame>At inclusion</time_frame>
    <description>a question on the presence or absence of toxic consomption will be asked to the teenager on a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean duration time in front of screen (hours per day)</measure>
    <time_frame>At inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence or absence of difficulties with social interactions</measure>
    <time_frame>At inclusion</time_frame>
    <description>A question on the presence or absence of difficulties with social interactions will be asked to the teenager on a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence or absence of difficulties with familial interactions</measure>
    <time_frame>At inclusion</time_frame>
    <description>Presence or absence of difficulties with familial interactions</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Psychological Adaptation</condition>
  <condition>Psychology, Social</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>An online questionnaire on the experience of the period of confinement and deconfinement will be sent to the cohort of adolescents followed at the CHI Creteil for a chronic disease or not. Forty adolescents will be randomly selected for a remote interview on the experience and memorization of the period of confinement and deconfinement.</description>
    <other_name>Interview</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be proposed to all the adolescents followed in the Centre hospitalier&#xD;
        Intercommunal de Creteil for a chronic disease or not.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents aged 11 to 18 years old&#xD;
&#xD;
          -  Previous consultation in the Centre Hospitalier intercommunal de Creteil&#xD;
&#xD;
          -  Agree to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of computer equipment or internet connection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Camille JUNG</name>
      <address>
        <city>Creteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>January 10, 2023</last_update_submitted>
  <last_update_submitted_qc>January 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04406558
org study id: COVADO
nct id: NCT04406558
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The lockdown of the French population is a health measure put in place in response to the
      pandemic linked to a new coronavirus, SARS-CoV-2 (Covid-19). After a health campaign to
      recommend hygienic "barrier gestures" and social distancing, the decision to confine the
      population at the national level was decided by the executive from Monday 16 March to Monday
      11 May 2020. The national confinement implies the restriction of movement to the strict
      necessary, outings near the home and the closure of schools and communities. These decisions
      have led to an unprecedented state of stress for the entire French population, the
      consequences of which are unknown in the short, medium or long term. The objectives of this
      study are to evaluate the psychological impact of the confinement on adolescents with or
      without chronic disease and also the difficulties and fears engendered by deconfinement .
observational model: Cohort
time perspective: Prospective
measure: Anxiety score from the Generalized Anxiety Disorder 7 (GAD-7) questionnaire
time frame: At inclusion
description: Scale 0-21
measure: Depression score from the Adolescent Depression Rating Scale (ADRS) questionnaire
time frame: At inclusion
description: Scale 0-60
measure: Post traumatic score questionnaire: Children's Revised Impact of Events Scales -CRIES13
time frame: At inclusion
description: 8 items that are scored on a four-point scale and 3 sub scales: intrusion (4 items); avoidance (4 items) and arousal (5 items)
measure: Presence or absence of difficulty in falling asleep, sleeping
time frame: At inclusion
description: a question on the quality and quantity of sleep will be asked to the teenager on a questionnaire
measure: Presence or absence of feeding difficulty
time frame: At inclusion
description: a question on the presence or absence of feeding difficulty will be asked to the teenager on a questionnaire
measure: Presence or absence of difficulty performing physical activity
time frame: At inclusion
description: a question on the presence or absence of difficulty performing physical activity will be asked to the teenager on a questionnaire
measure: Presence or absence of toxic consomption (drug, acohol) during the lockdown
time frame: At inclusion
description: a question on the presence or absence of toxic consomption will be asked to the teenager on a questionnaire
measure: Mean duration time in front of screen (hours per day)
time frame: At inclusion
measure: Presence or absence of difficulties with social interactions
time frame: At inclusion
description: A question on the presence or absence of difficulties with social interactions will be asked to the teenager on a questionnaire
measure: Presence or absence of difficulties with familial interactions
time frame: At inclusion
description: Presence or absence of difficulties with familial interactions
intervention type: Other
intervention name: Questionnaire
description: An online questionnaire on the experience of the period of confinement and deconfinement will be sent to the cohort of adolescents followed at the CHI Creteil for a chronic disease or not. Forty adolescents will be randomly selected for a remote interview on the experience and memorization of the period of confinement and deconfinement.
other name: Interview
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 11 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor