Clinical trial NCT04370210: Sleep Quality During COVID-19 Containment in Children Whether or Not Usually Followed in Child Psychiatry
Official title: Sleep Quality During COVID-19 Containment in Children 7 to 12 Years Old, Whether or Not Usually Followed in Child Psychiatry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disturbance
Keywords: Children
Sleep Disturbance scale for children
Containment
COVID-19
Anxiety
Psychological Distress
Sleep Wake Disorders
Child Psychiatry
Mental Health
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 247
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child aged 7 to 11 years and 11 months included on the first day of containment in France on 17 March 2020 and their parents

Brief summary: The purpose of this study is to determine whether sleep disturbances in children aged 7 to 12 during COVID-19 containment are more prevalent in children who received routine psychiatric care before containment compared to children who don't have any psychiatric care.

Detailed description: The coronavirus epidemic reached France in January 2020 and the WHO declared the COVID-19 outbreak was a pandemic on 11 March 2020. In response to this pandemic the French government announced national containment starting on 17 March 2020. Some recent studies suggest that a containment duration of more than 10 days and an extension beyond the originally announced duration would increase the psychological impact of it.

Sleep is a vital function that contributes to the proper neurophysiological and psychological development of human beings especially children. Sleep disorders can have a major impact on a child's behavior, mood, cognitive performance and metabolism. Sleep disorders are often associated with depression, anxiety and cognitive changes. Chronic sleep disorders are also risk factors for mental illness To our knowledge, no study targeting the quality of sleep in children who usually receive psychiatric care is underway or has been published. It is essential to ask what the quality of sleep in children with a psychiatric diagnosis who suddenly lose their bearings and their usual daily routine (school, therapeutic groups, day hospitals, etc.) after several weeks of containment.

This study is designed to assess different parameters in the 2 groups of children (healthy volunteers and Child with follow-up in child psychiatry) :

* the sleep quality,
* the depression level,
* the anxiety level,
* if socio-demographic factors have an influence on sleep disorders,
* if there is a correlation between children's sleep quality, and anxiety level / sleep quality in their parents.

Eligibility criteria: Inclusion Criteria:

* Child aged 7 to 11 years and 11 months included on the first day of containment in France on 17 March 2020
* Child receiving care at the CMP of Cergy-le-Haut (medico-psychological center) on the 2020 active patient population (at least one appointment with a child psychiatrist, a psychologist, a psychomotor therapist or a speech therapist or in a therapeutic group between January and March 2020)

OR

* Child not receiving any psychiatric care and having no siblings (half-brother, half-sister) followed in child psychiatry
* No parental opposition

Exclusion Criteria:

* Poor French reading comprehension by parents
* Objection of the child
* Child under guardianship, curatorship or foster care
* Child not on containment : child cared for outside his home everyday (in school and hospital daycare for example).

Primary outcomes:
measure: Comparison of sleep quality during COVID-19 containment between children usually followed in child psychiatry and children without follow-up
timeFrame: An average of 1 day
Secondary outcomes:
measure: Assessment of child depression in both groups
timeFrame: An average of 1 day
measure: Assessment of child anxiety in both groups
timeFrame: An average of 1 day
measure: Assessment of the influence of socio-demographic factors on sleep in both groups
timeFrame: An average of 1 day
measure: Measure of the correlation between child sleep quality and parents sleep quality (anxiety level) in both groups
timeFrame: An average of 1 day
measure: Assessment of sleep disturbance based on psychiatry diagnoses in the group of children usually followed in child psychiatry
timeFrame: An average of 1 day
measure: Assessment of child anxiety based on psychiatry diagnoses in the group of children usually followed in child psychiatry
timeFrame: An average of 1 day
measure: Assessment of child depression based on psychiatry diagnoses in the group of children usually followed in child psychiatry
timeFrame: An average of 1 day
Other outcomes:
Locations:
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
Study officials:
affiliation: Hôpital NOVO
name: Erwan VION
role: PRINCIPAL_INVESTIGATOR
References: