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Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder in Covid-19 Outbreak (CLIECO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04416360
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
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 (Brooks et al, 2020; Wang et al, 2020; Sprang et al, 2013). These problematic effects could be modulated by social factors (housing in urban or rural areas, availability of personal space at home, parenting stress, etc.) (Cluver et al, 2020; Liu et al, 2020).

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Attention-deficit Hyperactivity Disorder Other: Interview by psychologists Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : May 5, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Experimental: Interview by psychologists
Children and adolescent interview Parents interview Referring caregiver interview
Other: Interview by psychologists

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





Primary Outcome Measures :
  1. Interview of the parents : contextual data [ Time Frame: Baseline ]
    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.

  2. Interview of the children/adolescents/ parents : Experience of the confinement in general [ Time Frame: Baseline ]
    related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)

  3. Interview of the children/adolescents/ parents : Experience of the confinement in general [ Time Frame: 1 month ]
    related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)

  4. Interview of the children/adolescents/ parents : Experience of the confinement in general [ Time Frame: 3 months ]
    related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)

  5. Interview of the referring caregiver : data relating to disease and management of care [ Time Frame: 3 months ]
    Data relating to disease and management of care. Experience of the referring caregiver.



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Inclusion Criteria:

    Children / adolescents:

    • autism spectrum disorder (ASD) w/wo co-morbidities and/or attention-deficit - hyperactivity disorder (ADHD)
    • aged 6 to 17 years (developmental age)
    • cared by child psychiatry services involved in the study with continuing care (teleconsultations) during home confinement
    • at least one parent consent to participate in the study
    • child benefiting from a social security

    Parents: one or both parents depending on availability and confinement configurations (childcare)

    Referring caregivers: the referring caregiver will be identified at the time of the child's inclusion in the study

  2. Exclusion Criteria:

    • Parents subject to a judicial safeguard order, guardianship or trusteeship
    • Parents or children/adolescents who refuse to participate
    • Parents unable to comply with the study requirements because of language or because of lack of access to visio or telephone conference facilities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04416360


Contacts
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Contact: Malika DELOBEL-AYOUB 05 67 77 12 87 delobel.m@chu-toulouse.fr

Locations
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France
University hospital of Toulouse Recruiting
Toulouse, Occitanie, France, 31059
Contact: Malika DELOBEL-AYOUB       delobel.m@chu-toulouse.fr   
Principal Investigator: Malika DELOBEL-AYOUB         
Sub-Investigator: Jean-Philippe RAYNAUD         
Sub-Investigator: Thierry MAFFRE         
Centre Hospitalier de Versailles Recruiting
Le Chesnay, France, 78157
Contact: Mario SPERANZA       msperanza@ch-versailles.fr   
Principal Investigator: Mario SPERANZA         
Centre Hospitalier Esquirol Recruiting
Limoges, France, 87025
Contact: Bertrand OLLIAC       bertrand.olliac@ch-esquirol-limoges.fr   
Principal Investigator: Bertrand OLLIAC         
Hôpital Robert-Debré (AP-HP) Recruiting
Paris, France, 75019
Contact: Bruno FALISSARD       bruno.falissard@aphp.fr   
Principal Investigator: Bruno FALISSARD         
Maison de Solenn (Hôpital Cochin AP-HP) Recruiting
Paris, France, 75679
Contact: Laelia BENOIT       laelia.benoit@aphp.fr   
Principal Investigator: Laelia BENOIT         
Sponsors and Collaborators
University Hospital, Toulouse
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Malika DELOBEL-AYOUB University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04416360    
Other Study ID Numbers: RC31/20/0151
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
home confinement
Covid-19
qualitative research
Autism Spectrum Disorder
Attention-deficit Hyperactivity Disorder
Additional relevant MeSH terms:
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Hyperkinesis
Disease
Autistic Disorder
Attention Deficit Disorder with Hyperactivity
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases