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

Primary Purpose

Autism Spectrum Disorder, Attention-deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interview by psychologists
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring home confinement, Covid-19, qualitative research, Autism Spectrum Disorder, Attention-deficit Hyperactivity Disorder

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers
  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

Sites / Locations

  • University hospital of Toulouse
  • Centre Hospitalier de Versailles
  • Centre Hospitalier Esquirol
  • Hôpital Robert-Debré (AP-HP)
  • Maison de Solenn (Hôpital Cochin AP-HP)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interview by psychologists

Arm Description

Children and adolescent interview Parents interview Referring caregiver interview

Outcomes

Primary Outcome Measures

Interview of the parents : contextual data
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.
Interview of the children/adolescents/ parents : Experience of the confinement in general
related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Interview of the children/adolescents/ parents : Experience of the confinement in general
related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Interview of the children/adolescents/ parents : Experience of the confinement in general
related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Interview of the referring caregiver : data relating to disease and management of care
Data relating to disease and management of care. Experience of the referring caregiver.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2020
Last Updated
May 22, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT04416360
Brief Title
Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder in Covid-19 Outbreak
Acronym
CLIECO
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. These problematic effects could be modulated by social factors (housing in urban or rural areas, availability of personal space at home, parenting stress, etc.).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Attention-deficit Hyperactivity Disorder
Keywords
home confinement, Covid-19, qualitative research, Autism Spectrum Disorder, Attention-deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interview by psychologists
Arm Type
Experimental
Arm Description
Children and adolescent interview Parents interview Referring caregiver interview
Intervention Type
Other
Intervention Name(s)
Interview by psychologists
Intervention 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
Primary Outcome Measure Information:
Title
Interview of the parents : contextual data
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.
Time Frame
Baseline
Title
Interview of the children/adolescents/ parents : Experience of the confinement in general
Description
related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Time Frame
Baseline
Title
Interview of the children/adolescents/ parents : Experience of the confinement in general
Description
related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Time Frame
1 month
Title
Interview of the children/adolescents/ parents : Experience of the confinement in general
Description
related to education; related to daily family life; related to leisure, related to care (children/adolescents, parents)
Time Frame
3 months
Title
Interview of the referring caregiver : data relating to disease and management of care
Description
Data relating to disease and management of care. Experience of the referring caregiver.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malika DELOBEL-AYOUB
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Toulouse
City
Toulouse
State/Province
Occitanie
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Hospitalier de Versailles
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Centre Hospitalier Esquirol
City
Limoges
ZIP/Postal Code
87025
Country
France
Facility Name
Hôpital Robert-Debré (AP-HP)
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Maison de Solenn (Hôpital Cochin AP-HP)
City
Paris
ZIP/Postal Code
75679
Country
France

12. IPD Sharing Statement

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

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