Investigating Psychological ImpactPSICOcsNCT04475484
Online Survey on Psychological Impact of COVID-19 Epidemic on School-age Children
An observational study of Investigating Psychological Impact and Confinement Measures, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The coronavirus outbreak is a stressful event for the whole population. Confinement measures are protective against the risk of dissemination of the virus, but they can also lead to several psychological symptoms. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Investigating Psychological Impact, Confinement Measures, Coronavirus Outbreak
- What is being tested?
- Online questionnaire
- How many people
- 30,000 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2020to 31 Dec 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: School-age children from primary school to high school (about age 6 to 18) in the Academy of Lyon
Who may be able to join
- school-age children in the Academy of Lyon
- parental consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
hôpital Femme Mère Enfant
Bron, 69500
Pauline Espi, 4 72 12 95 62 ext. +33, pauline.espi@chu-lyon.fr
Pierre Fourneret, 4 72 12 95 62 ext. +33, pierre.fourneret@chu-lyon.fr
About this study
The coronavirus outbreak is a stressful event for the whole population. Confinement measures are protective against the risk of dissemination of the virus, but they can also lead to several psychological symptoms. In children, a study in China has reported about 20% of depressive or anxious troubles in school-age children after a 4-week period of confinement.
In France, confinement lasted about 8 weeks. School resumed on May 11th for primary school children and on June 2nd for secondary school children.
In this survey, we aim at exploring the psychological status of these children and the impact on their schooling, for better understanding, support and prevention. Through this online questionnaire, we also aim at giving some psycho-education advices. Finally, we could identify some subgroups of children particularly vulnerable, and organise some specific support for them in coming months.
- Conditions
- Investigating Psychological Impact, Confinement Measures, Coronavirus Outbreak, School-age Children
- Being tested
- Online questionnaire
- Keywords
- coronavirus epidemic, Children, Schooling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online questionnaireOther
Parents will receive a link to an online questionnaire through computing services of Lyon's Academy. They have to give their consent to allow their child to participate in the study. Then, children can complete the online questionnaire.
The questionnaire starts with few explanations on the context of the study, and ends with psycho-education advices and what to do in the event of psychological distress.
| Study group | Role | What they receive |
|---|---|---|
| School-age children | School-age children from primary school to high school (about age 6 to 18) in the Academy of Lyon Receives: Other: Online questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children presenting signs of psychological suffering during confinement.
We plan to assess the psychological status of children during coronavirus outbreak : negative and positive feeling during confinement, worries and expectations about school resumption.
We also aim at correlating high stress levels with environmental or/and temperamental factors.
Measured: We plan to address a first online questionnaire in June 2020 (school resumption after confinement), and a follow-up questionnaire 3 months later, in September 2020.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start10 Jun 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Investigating Psychological ImpactStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475484
- Sponsor's protocol ID
- PSICOcs_2020
- Acronym
- PSICOcs
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Survey on Psychological Impact of COVID-19 Epidemic on School-age Children
- ClinicalTrials.gov ID
- NCT04475484
- Acronym / sponsor ID
- PSICOcs / PSICOcs_2020
- Conditions
- Investigating Psychological Impact, Confinement Measures, Coronavirus Outbreak, School-age Children
- Keywords
- coronavirus epidemic, Children, Schooling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Jul 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 coronavirus outbreak is a stressful event for the whole population. Confinement measures are protective against the risk of dissemination of the virus, but they can also lead to several psychological symptoms. In children, a study in China has reported about 20% of depressive or anxious troubles in school-age children after a 4-week period of confinement.
In France, confinement lasted about 8 weeks. School resumed on May 11th for primary school children and on June 2nd for secondary school children.
In this survey, we aim at exploring the psychological status of these children and the impact on their schooling, for better understanding, support and prevention. Through this online questionnaire, we also aim at giving some psycho-education advices. Finally, we could identify some subgroups of children particularly vulnerable, and organise some specific support for them in coming months.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| School-age children | – | Other: Online questionnaireSchool-age children from primary school to high school (about age 6 to 18) in the Academy of Lyon |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- School-age children from primary school to high school (about age 6 to 18) in the Academy of Lyon
Key inclusion criteria (2 listed)
- school-age children in the Academy of Lyon
- parental consent
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Online questionnaireParents will receive a link to an online questionnaire through computing services of Lyon's Academy. They have to give their consent to allow their child to participate in the study. Then, children can complete the online questionnaire. The questionnaire starts with few explanations on the context of the study, and ends with psycho-education advices and what to do in the event of psychological distress. | Other | School-age children |
Primary outcome
Proportion of children presenting signs of psychological suffering during confinement.
Time frame: We plan to address a first online questionnaire in June 2020 (school resumption after confinement), and a follow-up questionnaire 3 months later, in September 2020.
We plan to assess the psychological status of children during coronavirus outbreak : negative and positive feeling during confinement, worries and expectations about school resumption. We also aim at correlating high stress levels with environmental or/and temperamental factors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
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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.
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 Investigating Psychological Impact and Confinement Measures, run by Hospices Civils de Lyon 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauline Espi (4 72 12 95 62 ext. +33, pauline.espi@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children presenting signs of psychological suffering during confinement. (time frame: We plan to address a first online questionnaire in June 2020 (school resumption after confinement), and a follow-up questionnaire 3 months later, in September 2020.). 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 17 Jul 2020.