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Clinical Trials/NCT04416360
NCT04416360
Completed
Not Applicable

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

University Hospital, Toulouse5 sites in 1 country35 target enrollmentMay 5, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
University Hospital, Toulouse
Enrollment
35
Locations
5
Primary Endpoint
Interview of the referring caregiver : data relating to disease and management of care
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 5, 2020
End Date
October 30, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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)

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.

Study Sites (5)

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