Sleep DisturbanceCONFIDODONCT04370210
Sleep Quality During COVID-19 Containment in Children Whether or Not Usually Followed in Child Psychiatry
An observational study of Sleep Disturbance, run by Hôpital NOVO at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 247 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2020to 4 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Quality During COVID-19 Containment in Children 7 to 12 Years Old, Whether or Not Usually Followed in Child Psychiatry
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.
Read the 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.
- Conditions
- Sleep Disturbance
- Being tested
- Questionnaires
- Keywords
- Children, Sleep Disturbance scale for children, Containment, COVID-19, Anxiety, Psychological Distress, Sleep Wake Disorders, Child Psychiatry, Mental Health
- Medical subject headings
- Parasomnias, COVID-19, Anxiety Disorders, Sleep Wake Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Child of both groups enrolled, and their parents, must complete online questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Child without follow-up in child psychiatry | Child enrolled, and their parents, must complete online questionnaires Receives: Behavioral: Questionnaires | |
| Child with follow-up in child psychiatry | Child enrolled, and their parents, must complete online questionnaires Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: An average of 1 day
Secondary outcomes (7)
Assessment of child depression in both groups
Child depression is measured using Child Depression Inventory Scale (CDI scale). For each item the score is graded by severity from 0 (normal behavior) to 2 (severe).
Measured: An average of 1 day
Assessment of child anxiety in both groups
Child anxiety is measured using Revised Children's Manifest Anxiety Scale (RCMAS). For each item, child answer by Yes or No. The total score is interpreted using the correspondence tables in function of sex and age
Measured: An average of 1 day
Assessment of the influence of socio-demographic factors on sleep in both groups
Sleep quality is assessed with the Sleep Disturbance Scale for Children (SDSC scale). The score obtained is interpreted in function of socio-demographic factors (age, sex, lifestyle, couple status, profession and socio-professional category, education)
Measured: An average of 1 day
Measure of the correlation between child sleep quality and parents sleep quality (anxiety level) in both groups
Sleep quality is assessed with the Sleep Disturbance Scale for Children (SDSC scale). For their parents, sleep quality and anxiety level are measured with a numerical scale between 0 and 10. For sleep quality, 0 correspond to a very poor quality and 10 to a very good quality. For anxiety level, 0 correspond to no anxiety and 10 to a severe anxiety. The score obtained for child is interpreted in function of their parents score.
Measured: An average of 1 day
Assessment of sleep disturbance based on psychiatry diagnoses in the group of children usually followed in child psychiatry
Sleep quality is assessed with the Sleep Disturbance Scale for Children (SDSC scale). The score obtained is interpreted in function of child psychiatry diagnoses coded with Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Measured: An average of 1 day
Assessment of child anxiety based on psychiatry diagnoses in the group of children usually followed in child psychiatry
Child anxiety is measured using Revised Children's Manifest Anxiety Scale (RCMAS). For each item, child answer by Yes or No.
The score obtained is interpreted in function of child psychiatry diagnoses coded with Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Measured: An average of 1 day
Assessment of child depression based on psychiatry diagnoses in the group of children usually followed in child psychiatry
Child depression is measured using Child Depression Inventory Scale (CDI scale). For each item the score is graded by severity from 0 (normal behavior) to 2 (severe).
The score obtained is interpreted in function of child psychiatry diagnoses coded with Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Measured: An average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start4 May 2020
- Primary completion4 Jun 2020
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erwan VION, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370210
- Sponsor's protocol ID
- CHRD 0520
- Acronym
- CONFIDODO
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality During COVID-19 Containment in Children 7 to 12 Years Old, Whether or Not Usually Followed in Child Psychiatry
- ClinicalTrials.gov ID
- NCT04370210
- Acronym / sponsor ID
- CONFIDODO / CHRD 0520
- Conditions
- Sleep Disturbance
- Keywords
- Children, Sleep Disturbance scale for children, Containment, COVID-19, Anxiety, Psychological Distress, Sleep Wake Disorders, Child Psychiatry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child without follow-up in child psychiatry | – | Behavioral: QuestionnairesChild enrolled, and their parents, must complete online questionnaires |
| Child with follow-up in child psychiatry | – | Behavioral: QuestionnairesChild enrolled, and their parents, must complete online questionnaires |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesChild of both groups enrolled, and their parents, must complete online questionnaires | Behavioural | Child with follow-up in child psychiatry, Child without follow-up in child psychiatry |
Primary outcome
Comparison of sleep quality during COVID-19 containment between children usually followed in child psychiatry and children without follow-up
Time frame: An average of 1 day
Sleep quality is assessed in both groups with the Sleep Disturbance Scale for Children (SDSC scale). A score ≥ 45/125 is considered as pathological.
7 secondary outcomes
Assessment of child depression in both groups
Time frame: An average of 1 day
Assessment of child anxiety in both groups
Time frame: An average of 1 day
Assessment of the influence of socio-demographic factors on sleep in both groups
Time frame: An average of 1 day
Measure of the correlation between child sleep quality and parents sleep quality (anxiety level) in both groups
Time frame: An average of 1 day
Assessment of sleep disturbance based on psychiatry diagnoses in the group of children usually followed in child psychiatry
Time frame: An average of 1 day
Assessment of child anxiety based on psychiatry diagnoses in the group of children usually followed in child psychiatry
Time frame: An average of 1 day
Assessment of child depression based on psychiatry diagnoses in the group of children usually followed in child psychiatry
Time frame: An average of 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erwan VION principal investigator
Hôpital NOVO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disturbance, run by Hôpital NOVO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of sleep quality during COVID-19 containment between children usually followed in child psychiatry and children without follow-up (time frame: An average of 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.