<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/NCT04416360</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/20/0151</org_study_id>
    <nct_id>NCT04416360</nct_id>
  </id_info>
  <brief_title>Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder in Covid-19 Outbreak</brief_title>
  <acronym>CLIECO</acronym>
  <official_title>Clinical Evolution and Parenting in Children and Adolescents With Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder Quarantined Because of Covid-19 Outbreak</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Toulouse</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 response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the&#xD;
      population ordered by governments in many countries raise questions about its impact on&#xD;
      individuals' physical and mental health in the short and longer term. In children, reduced&#xD;
      physical activity, changes in lifestyle, disturbances in sleep patterns, lack of in-person&#xD;
      contact with peers, poor or inadequate understanding of health risks may be risk factors of&#xD;
      anxiety, stress, fatigue, sleep disorders. These problematic effects could be modulated by&#xD;
      social factors (housing in urban or rural areas, availability of personal space at home,&#xD;
      parenting stress, etc.).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children with Autism Spectrum Disorder (ASD) and/or hyperactive children (ADHD) usually have&#xD;
      behavioral and emotional difficulties. The disorders they suffer from, which considerably&#xD;
      disturb family life, the therapies they benefit from, which help to organize and structure&#xD;
      their daily lives, make them a coherent study group whose observation during home confinement&#xD;
      is particularly relevant. Therefore, it is especially interesting to explore the impact of&#xD;
      quarantine on the evolution of clinical symptoms and family dynamic.&#xD;
&#xD;
      There is little evidence about the impact of prolonged confinement in these children. The&#xD;
      first clinical observations, at the beginning of confinement, reported various situations.&#xD;
      Some children showed marked emotional disturbances, whereas others seem to be happy with less&#xD;
      social pressure. For ASDs, the ritualization can be a stabilizing factor. For ADHDs, the&#xD;
      decrease in school pressure is undoubtedly a positive factor. The availability of parents to&#xD;
      create a suitable environment could play a major role. In all cases, changes in care&#xD;
      management (teleconsultations for most of them), disruption in routines and lack of points of&#xD;
      reference, adjustment in parenting and caring for children for the parents (with difficulties&#xD;
      that could increase with prolonged duration of confinement), could have serious long-term&#xD;
      effects, but also create opportunities.&#xD;
&#xD;
      So, the present study aim to document the experience of home confinement in children and&#xD;
      adolescents with ASD and/or ADHD quarantined because of covid-19 outbreak in various&#xD;
      socio-cultural contexts. The experiences reported by the children, their parents and their&#xD;
      caregivers will help understand the psychological impact of quarantine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interview of the parents : contextual data</measure>
    <time_frame>Baseline</time_frame>
    <description>composition, home confinement, change in the environment, personal room at home, screens with internet access, parents' current professional status, teleworking, care, family concerns related to Covid-19, parenting stress, schooling, recurrent complaints.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interview of the children/adolescents/ parents : Experience of the confinement in general</measure>
    <time_frame>Baseline</time_frame>
    <description>related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interview of the children/adolescents/ parents : Experience of the confinement in general</measure>
    <time_frame>1 month</time_frame>
    <description>related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interview of the children/adolescents/ parents : Experience of the confinement in general</measure>
    <time_frame>3 months</time_frame>
    <description>related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interview of the referring caregiver : data relating to disease and management of care</measure>
    <time_frame>3 months</time_frame>
    <description>Data relating to disease and management of care. Experience of the referring caregiver.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Attention-deficit Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>Interview by psychologists</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children and adolescent interview Parents interview Referring caregiver interview</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview by psychologists</intervention_name>
    <description>Interviews for children / teenagers and parents :&#xD;
The questions encourage a narrative&#xD;
Repeated interviews: during confinement, at the end of confinement, and 3 months after the end of confinement&#xD;
Interviews carried out by videoconference, by trained psychologists not involved in the care process&#xD;
Interview for referring caregivers: a single interview of approximately 45 minutes, 3 months post-confinement</description>
    <arm_group_label>Interview by psychologists</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Inclusion Criteria:&#xD;
&#xD;
             Children / adolescents:&#xD;
&#xD;
               -  autism spectrum disorder (ASD) w/wo co-morbidities and/or attention-deficit -&#xD;
                  hyperactivity disorder (ADHD)&#xD;
&#xD;
               -  aged 6 to 17 years (developmental age)&#xD;
&#xD;
               -  cared by child psychiatry services involved in the study with continuing care&#xD;
                  (teleconsultations) during home confinement&#xD;
&#xD;
               -  at least one parent consent to participate in the study&#xD;
&#xD;
               -  child benefiting from a social security&#xD;
&#xD;
             Parents: one or both parents depending on availability and confinement configurations&#xD;
             (childcare)&#xD;
&#xD;
             Referring caregivers: the referring caregiver will be identified at the time of the&#xD;
             child's inclusion in the study&#xD;
&#xD;
          2. Exclusion Criteria:&#xD;
&#xD;
               -  Parents subject to a judicial safeguard order, guardianship or trusteeship&#xD;
&#xD;
               -  Parents or children/adolescents who refuse to participate&#xD;
&#xD;
               -  Parents unable to comply with the study requirements because of language or&#xD;
                  because of lack of access to visio or telephone conference facilities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Malika DELOBEL-AYOUB</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University hospital of Toulouse</name>
      <address>
        <city>Toulouse</city>
        <state>Occitanie</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Versailles</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78157</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Esquirol</name>
      <address>
        <city>Limoges</city>
        <zip>87025</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Robert-Debré (AP-HP)</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maison de Solenn (Hôpital Cochin AP-HP)</name>
      <address>
        <city>Paris</city>
        <zip>75679</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>home confinement</keyword>
  <keyword>Covid-19</keyword>
  <keyword>qualitative research</keyword>
  <keyword>Autism Spectrum Disorder</keyword>
  <keyword>Attention-deficit Hyperactivity Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</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/NCT04416360
org study id: RC31/20/0151
nct id: NCT04416360
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In response to the coronavirus disease 2019 (covid-19) outbreak, the home confinement of the
      population ordered by governments in many countries raise questions about its impact on
      individuals' physical and mental health in the short and longer term. In children, reduced
      physical activity, changes in lifestyle, disturbances in sleep patterns, lack of in-person
      contact with peers, poor or inadequate understanding of health risks may be risk factors of
      anxiety, stress, fatigue, sleep disorders. These problematic effects could be modulated by
      social factors (housing in urban or rural areas, availability of personal space at home,
      parenting stress, etc.).
Children with Autism Spectrum Disorder (ASD) and/or hyperactive children (ADHD) usually have
      behavioral and emotional difficulties. The disorders they suffer from, which considerably
      disturb family life, the therapies they benefit from, which help to organize and structure
      their daily lives, make them a coherent study group whose observation during home confinement
      is particularly relevant. Therefore, it is especially interesting to explore the impact of
      quarantine on the evolution of clinical symptoms and family dynamic.

      There is little evidence about the impact of prolonged confinement in these children. The
      first clinical observations, at the beginning of confinement, reported various situations.
      Some children showed marked emotional disturbances, whereas others seem to be happy with less
      social pressure. For ASDs, the ritualization can be a stabilizing factor. For ADHDs, the
      decrease in school pressure is undoubtedly a positive factor. The availability of parents to
      create a suitable environment could play a major role. In all cases, changes in care
      management (teleconsultations for most of them), disruption in routines and lack of points of
      reference, adjustment in parenting and caring for children for the parents (with difficulties
      that could increase with prolonged duration of confinement), could have serious long-term
      effects, but also create opportunities.

      So, the present study aim to document the experience of home confinement in children and
      adolescents with ASD and/or ADHD quarantined because of covid-19 outbreak in various
      socio-cultural contexts. The experiences reported by the children, their parents and their
      caregivers will help understand the psychological impact of quarantine.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Interview of the parents : contextual data
time frame: Baseline
description: composition, home confinement, change in the environment, personal room at home, screens with internet access, parents' current professional status, teleworking, care, family concerns related to Covid-19, parenting stress, schooling, recurrent complaints.
measure: Interview of the children/adolescents/ parents : Experience of the confinement in general
time frame: Baseline
description: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
measure: Interview of the children/adolescents/ parents : Experience of the confinement in general
time frame: 1 month
description: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
measure: Interview of the children/adolescents/ parents : Experience of the confinement in general
time frame: 3 months
description: related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
measure: Interview of the referring caregiver : data relating to disease and management of care
time frame: 3 months
description: Data relating to disease and management of care. Experience of the referring caregiver.
arm group label: Interview by psychologists
arm group type: Experimental
description: Children and adolescent interview Parents interview Referring caregiver interview
intervention type: Other
intervention name: Interview by psychologists
description: Interviews for children / teenagers and parents :
The questions encourage a narrative
Repeated interviews: during confinement, at the end of confinement, and 3 months after the end of confinement
Interviews carried out by videoconference, by trained psychologists not involved in the care process
Interview for referring caregivers: a single interview of approximately 45 minutes, 3 months post-confinement
arm group label: Interview by psychologists
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Malika DELOBEL-AYOUB
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Hyperkinesis
mesh term: Autistic Disorder
mesh term: Attention Deficit Disorder with Hyperactivity
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive