Clinical trial NCT04416360: Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder in Covid-19 Outbreak
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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Attention-deficit Hyperactivity Disorder
Keywords: home confinement
Covid-19
qualitative research
Autism Spectrum Disorder
Attention-deficit Hyperactivity Disorder
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-06-04
Enrollment: 35
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Interview of the parents : contextual data
timeFrame: Baseline
measure: Interview of the children/adolescents/ parents : Experience of the confinement in general
timeFrame: Baseline
measure: Interview of the children/adolescents/ parents : Experience of the confinement in general
timeFrame: 1 month
measure: Interview of the children/adolescents/ parents : Experience of the confinement in general
timeFrame: 3 months
measure: Interview of the referring caregiver : data relating to disease and management of care
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University hospital of Toulouse
state: Occitanie
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
city: Limoges
country: France
facility: Centre Hospitalier Esquirol
city: Paris
country: France
facility: Hôpital Robert-Debré (AP-HP)
city: Paris
country: France
facility: Maison de Solenn (Hôpital Cochin AP-HP)
Study officials:
affiliation: University Hospital, Toulouse
name: Malika DELOBEL-AYOUB
role: PRINCIPAL_INVESTIGATOR
References: