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

May 22, 2023 updated by: University Hospital, Toulouse

Clinical Evolution and Parenting in Children and Adolescents With Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder Quarantined Because of Covid-19 Outbreak

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.).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Chesnay, France, 78157
        • Centre Hospitalier de Versailles
      • Limoges, France, 87025
        • Centre Hospitalier Esquirol
      • Paris, France, 75019
        • Hôpital Robert-Debré (AP-HP)
      • Paris, France, 75679
        • Maison de Solenn (Hôpital Cochin AP-HP)
    • Occitanie
      • Toulouse, Occitanie, France, 31059
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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)
Baseline
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)
1 month
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)
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Malika DELOBEL-AYOUB, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2020

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/20/0151

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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