<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/NCT04498416</url>
  </required_header>
  <id_info>
    <org_study_id>20-HPNCL-05</org_study_id>
    <nct_id>NCT04498416</nct_id>
  </id_info>
  <brief_title>CoCo-20: a Longitudinal Follow-up Study of the French Paediatric Population During and After the Coronavirus Pandemic COVID-19</brief_title>
  <acronym>CoCo-20</acronym>
  <official_title>Methodology of &quot; CoCo 20 &quot;: a Longitudinal Follow-up Study of the Paediatric Population and Their Families During and After the Coronavirus Pandemic and the Confinement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Lenval</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Lenval</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>
      In the context of a viral outbreak and of widespread quarantine measures, a significant&#xD;
      increase in psychological disorders, such as stress or fear behaviours, had previously been&#xD;
      observed. This distress has been described on adults, but no data have been collected yet for&#xD;
      paediatric populations.&#xD;
&#xD;
      After a traumatic event, children and adolescents may present several clinical consequences,&#xD;
      the most common being Post-Traumatic Stress Disorder (PTSD). Moreover, PTSD in children and&#xD;
      adolescents is often associated with comorbid disorders, such Attention Deficit Hyperactivity&#xD;
      Disorder, depression, attachment and anxiety disorders, sleep disturbances and behavior&#xD;
      problems.&#xD;
&#xD;
      The aim of this study is to present the methodology of &quot;CoCo 20&quot; : is to assess the impact of&#xD;
      the pandemic of coronavirus disease 2019 (Covid-19) and of seclusion measures on mental&#xD;
      health and on the development of psychological disorders in children in the short to medium&#xD;
      term&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the context of a viral outbreak and of widespread quarantine measures, a significant&#xD;
      increase in psychological disorders, such as stress or fear behaviours, had previously been&#xD;
      observed. This distress has been described on adults, but no data have been collected yet for&#xD;
      paediatric populations.&#xD;
&#xD;
      After a traumatic event, children and adolescents may present several clinical consequences,&#xD;
      the most common being Post-Traumatic Stress Disorder (PTSD). Moreover, PTSD in children and&#xD;
      adolescents is often associated with comorbid disorders, such Attention Deficit Hyperactivity&#xD;
      Disorder, depression, attachment and anxiety disorders, sleep disturbances and behavior&#xD;
      problems.&#xD;
&#xD;
      The aim of this study is to present the methodology of &quot;CoCo 20&quot; : is to assess the impact of&#xD;
      the pandemic of coronavirus disease (Covid-19) and of seclusion measures on mental health and&#xD;
      on the development of psychological disorders in children in the short to medium term.&#xD;
&#xD;
      The major inclusion criteria are children and adolescents under 18 years of age who have been&#xD;
      affected by the Covid 19 pandemic. Three groups were defined: children in group one had a&#xD;
      previous history of traumatic events, those in group two had a record of previous psychiatric&#xD;
      or psychological disorder with a follow-up treatment and Group three included children&#xD;
      without traumatic history nor psychiatric or psychological follow-up treatment. Participants&#xD;
      will be assessed at baseline (V0), 1 week after (V1), one month after baseline (V2), one week&#xD;
      after the end of the containment (V3) and one month after the end of the containment (V4).&#xD;
&#xD;
      Main analyses comprise analyses of variance and regression analyses of predictors of clinical&#xD;
      evolution over time&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 27, 2020</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</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>diagnosis of possible psychological and psychiatric difficulties at baseline</measure>
    <time_frame>at baseline Day 0</time_frame>
    <description>measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments :</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>follow up of psychological and psychiatric difficulties at V2</measure>
    <time_frame>at one month after baseline</time_frame>
    <description>measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>follow up of psychological and psychiatric difficulties at V3</measure>
    <time_frame>at one week after the end of the containment</time_frame>
    <description>measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>follow up of psychological and psychiatric difficulties at V4</measure>
    <time_frame>at one month after the end of the containment</time_frame>
    <description>measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>impact of traumatic history prior to confinement</measure>
    <time_frame>at one week after baseline and at one month after the end of the containment</time_frame>
    <description>measure by Post-Traumatic Stress Disorder (PTSD) scale: The frequency and intensity of PTSD symptoms will be assessed using the Young Child PTSD Checklist (YCP) for children aged 3 months to 6 years and 11 months; or the Child PTSD checklist (CPC) for children aged 7 years to 17 years and 11 months ; or with the Post-Traumatic Stress Disorder ( PTSD) checklist 5 (PCL 5 ) for adults</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>impact of other previous psychiatric disorders</measure>
    <time_frame>at one month after baseline and at one month after the end of the containment</time_frame>
    <description>measure by Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS): This is a semi-directed interview for children over the age of 7. It is done by interviewing the parent and the child. The interview covers both current issues.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>parental reaction</measure>
    <time_frame>at one week after baseline and at one week after the end of the containment</time_frame>
    <description>measure by Parenting stress index-short form (PSI-SF) that measures the extent of parental stress, as well as stress in the relationship between parent and child, and parents' difficulties in the day-to-day management of children.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Mental Health Disorder</condition>
  <arm_group>
    <arm_group_label>Group 1 Post-Traumatic Stress Disorder (PTSD)</arm_group_label>
    <description>children with an identified traumatic history</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 Pathology</arm_group_label>
    <description>children with psychological follow-up treatment for a psychiatric disorder, without traumatic history;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 Control</arm_group_label>
    <description>children without traumatic experience and without psychiatric or psychological follow-up treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Quantitative and qualitative assessments of mental health</intervention_name>
    <description>Emergency semi-directed interview; Diagnosis Infant and Preschool Assessment (DIPA); Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS); Conners Scale - short version;Weiss functional impairment rating scale - parent (WFIRS); Parenting stress index-short form (PSI-SF); Anxiety Scale</description>
    <arm_group_label>Group 1 Post-Traumatic Stress Disorder (PTSD)</arm_group_label>
    <arm_group_label>Group 2 Pathology</arm_group_label>
    <arm_group_label>Group 3 Control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Group 1 (PTSD): children with an identified traumatic history; Group 2 (Pathology):&#xD;
        children with psychological follow-up treatment for a psychiatric disorder, without&#xD;
        traumatic history; Group 3 (Control): children without traumatic experience and without&#xD;
        psychiatric or psychological follow-up treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children affected by the Coronavirus disease 2019 (Covid-19) pandemic;&#xD;
&#xD;
          -  Age between 0 and under 18 at the time of inclusion;&#xD;
&#xD;
          -  Affiliated with a social security scheme;&#xD;
&#xD;
          -  Having a good command of the French language (French);&#xD;
&#xD;
          -  Children whose parents have accepted participation in the study (collection of&#xD;
             informed consents).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children and/or young adults with a psychotic disorder or autism spectrum disorder;&#xD;
&#xD;
          -  Children and/or young adults with an average intellectual disability (&lt; to 50);&#xD;
&#xD;
          -  Person deprived of liberty by judicial or administrative decision1;&#xD;
&#xD;
          -  Person subject to a period of exclusion for another search.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Florence Gittard-Askenazy, Pr</last_name>
    <role>Study Director</role>
    <affiliation>Hôpitaux Pédiatriques de Nice CHU-LENVAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpitaux Pédiatriques de Nice CHU-Lenval</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</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>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/NCT04498416
org study id: 20-HPNCL-05
nct id: NCT04498416
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the context of a viral outbreak and of widespread quarantine measures, a significant
      increase in psychological disorders, such as stress or fear behaviours, had previously been
      observed. This distress has been described on adults, but no data have been collected yet for
      paediatric populations.

      After a traumatic event, children and adolescents may present several clinical consequences,
      the most common being Post-Traumatic Stress Disorder (PTSD). Moreover, PTSD in children and
      adolescents is often associated with comorbid disorders, such Attention Deficit Hyperactivity
      Disorder, depression, attachment and anxiety disorders, sleep disturbances and behavior
      problems.

      The aim of this study is to present the methodology of "CoCo 20" : is to assess the impact of
      the pandemic of coronavirus disease 2019 (Covid-19) and of seclusion measures on mental
      health and on the development of psychological disorders in children in the short to medium
      term
In the context of a viral outbreak and of widespread quarantine measures, a significant
      increase in psychological disorders, such as stress or fear behaviours, had previously been
      observed. This distress has been described on adults, but no data have been collected yet for
      paediatric populations.

      After a traumatic event, children and adolescents may present several clinical consequences,
      the most common being Post-Traumatic Stress Disorder (PTSD). Moreover, PTSD in children and
      adolescents is often associated with comorbid disorders, such Attention Deficit Hyperactivity
      Disorder, depression, attachment and anxiety disorders, sleep disturbances and behavior
      problems.

      The aim of this study is to present the methodology of "CoCo 20" : is to assess the impact of
      the pandemic of coronavirus disease (Covid-19) and of seclusion measures on mental health and
      on the development of psychological disorders in children in the short to medium term.

      The major inclusion criteria are children and adolescents under 18 years of age who have been
      affected by the Covid 19 pandemic. Three groups were defined: children in group one had a
      previous history of traumatic events, those in group two had a record of previous psychiatric
      or psychological disorder with a follow-up treatment and Group three included children
      without traumatic history nor psychiatric or psychological follow-up treatment. Participants
      will be assessed at baseline (V0), 1 week after (V1), one month after baseline (V2), one week
      after the end of the containment (V3) and one month after the end of the containment (V4).

      Main analyses comprise analyses of variance and regression analyses of predictors of clinical
      evolution over time
observational model: Cohort
time perspective: Prospective
measure: diagnosis of possible psychological and psychiatric difficulties at baseline
time frame: at baseline Day 0
description: measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments :
measure: follow up of psychological and psychiatric difficulties at V2
time frame: at one month after baseline
description: measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments
measure: follow up of psychological and psychiatric difficulties at V3
time frame: at one week after the end of the containment
description: measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments
measure: follow up of psychological and psychiatric difficulties at V4
time frame: at one month after the end of the containment
description: measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments
measure: impact of traumatic history prior to confinement
time frame: at one week after baseline and at one month after the end of the containment
description: measure by Post-Traumatic Stress Disorder (PTSD) scale: The frequency and intensity of PTSD symptoms will be assessed using the Young Child PTSD Checklist (YCP) for children aged 3 months to 6 years and 11 months; or the Child PTSD checklist (CPC) for children aged 7 years to 17 years and 11 months ; or with the Post-Traumatic Stress Disorder ( PTSD) checklist 5 (PCL 5 ) for adults
measure: impact of other previous psychiatric disorders
time frame: at one month after baseline and at one month after the end of the containment
description: measure by Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS): This is a semi-directed interview for children over the age of 7. It is done by interviewing the parent and the child. The interview covers both current issues.
measure: parental reaction
time frame: at one week after baseline and at one week after the end of the containment
description: measure by Parenting stress index-short form (PSI-SF) that measures the extent of parental stress, as well as stress in the relationship between parent and child, and parents' difficulties in the day-to-day management of children.
arm group label: Group 1 Post-Traumatic Stress Disorder (PTSD)
description: children with an identified traumatic history
arm group label: Group 2 Pathology
description: children with psychological follow-up treatment for a psychiatric disorder, without traumatic history;
arm group label: Group 3 Control
description: children without traumatic experience and without psychiatric or psychological follow-up treatment.
intervention type: Diagnostic Test
intervention name: Quantitative and qualitative assessments of mental health
description: Emergency semi-directed interview; Diagnosis Infant and Preschool Assessment (DIPA); Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS); Conners Scale - short version;Weiss functional impairment rating scale - parent (WFIRS); Parenting stress index-short form (PSI-SF); Anxiety Scale
arm group label: Group 1 Post-Traumatic Stress Disorder (PTSD)
arm group label: Group 2 Pathology
arm group label: Group 3 Control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Florence Gittard-Askenazy, Pr
role: Study Director
affiliation: Hôpitaux Pédiatriques de Nice CHU-LENVAL
facility: 
country: France
responsible party type: Sponsor
mesh term: Mental Disorders