Sleep Quality During COVID-19 Containment in Children Whether or Not Usually Followed in Child Psychiatry
CONFIDODO
1 other identifier
observational
247
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2020
CompletedFirst Posted
Study publicly available on registry
April 30, 2020
CompletedStudy Start
First participant enrolled
May 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2020
CompletedSeptember 19, 2024
April 1, 2020
1 month
April 29, 2020
September 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of sleep quality during COVID-19 containment between children usually followed in child psychiatry and children without follow-up
Sleep quality is assessed in both groups with the Sleep Disturbance Scale for Children (SDSC scale). A score ≥ 45/125 is considered as pathological.
An average of 1 day
Secondary Outcomes (7)
Assessment of child depression in both groups
An average of 1 day
Assessment of child anxiety in both groups
An average of 1 day
Assessment of the influence of socio-demographic factors on sleep in both groups
An average of 1 day
Measure of the correlation between child sleep quality and parents sleep quality (anxiety level) in both groups
An average of 1 day
Assessment of sleep disturbance based on psychiatry diagnoses in the group of children usually followed in child psychiatry
An average of 1 day
- +2 more secondary outcomes
Study Arms (2)
Child without follow-up in child psychiatry
Child enrolled, and their parents, must complete online questionnaires
Child with follow-up in child psychiatry
Child enrolled, and their parents, must complete online questionnaires
Interventions
Child of both groups enrolled, and their parents, must complete online questionnaires
Eligibility Criteria
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
You may qualify if:
- 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)
- Child not receiving any psychiatric care and having no siblings (half-brother, half-sister) followed in child psychiatry
- No parental opposition
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hôpital NOVOlead
Study Sites (1)
Centre Hospitalier René Dubos
Pontoise, 95300, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erwan VION
Hôpital NOVO
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2020
First Posted
April 30, 2020
Study Start
May 4, 2020
Primary Completion
June 4, 2020
Study Completion
June 4, 2020
Last Updated
September 19, 2024
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share