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

Autism Spectrum Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416360
• Other study ID #: RC31/20/0151
• Status: Completed
• Phase: N/A
• Start date: May 5, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: May 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-deficit Hyperactivity Disorder
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• COVID-19
• Disease
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier de Versailles	Le Chesnay
France	Centre Hospitalier Esquirol	Limoges
France	Hôpital Robert-Debré (AP-HP)	Paris
France	Maison de Solenn (Hôpital Cochin AP-HP)	Paris
France	University hospital of Toulouse	Toulouse	Occitanie

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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)	Baseline
Primary	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)	1 month
Primary	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)	3 months
Primary	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.	3 months