Post Traumatic Stress DisorderE-COCCONNCT04615195
Effect of COVID-19 Related COntainment in ChildreN
An observational study of Post Traumatic Stress Disorder, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The current pandemic situation (SRAS COV2) is an unprecedented event and a source of stress potentially aggravated by containment. The Child Revised Impact Event Scale (CRIES-13) was evaluated in children 8 years or older in survivors of traumatic events, flood, stay in intensive care, or war (Bosnia). Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- cries 13 questionnaire
- How many people
- 703 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2020to 30 Sep 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 8 to 15 years
- All sexes
- Child
Study population: All children aged between 8 and 15 accepting to participate and whose parents accepting to particpate
Who may be able to join
- Binomial of child (aged between 8 and 15) and one of its holders of parental authority agreeing to participate
Who cannot join
- children aged under 8 and over 15
- children whose parents are opposed
- children refusing to participate
- holders of minor parental authority
Trial locations and contacts
1 site in 1 country.
About this study
The current pandemic situation (SRAS COV2) is an unprecedented event and a source of stress potentially aggravated by containment. The Child Revised Impact Event Scale (CRIES-13) was evaluated in children 8 years or older in survivors of traumatic events, flood, stay in intensive care, or war (Bosnia). In this study CRIES-13 will be used to determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020
Read the detailed description
Parents of children aged 8 to 15 will be approached from different levels / places of selection / recruitment. A clinical researcher of pediatric clinical investigation center will collect the responses.
If one of the holders of parental authority and the child agree to participate, an information notice will be sent to them, then they will be contacted by telephone by a clinical research assistant to answer the questionnaire.
In large families, the CRIES-13 of the holder of parental authority and of the child will be applied for each of them whose age corresponds to the inclusion criteria.
The duration of the study / participant call and effective response to the questionnaire by the holder of parental authority and the child will takes a maximum of 20 minutes.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- cries 13 questionnaire
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cries 13 questionnaireOther
Participant will be contacted by telephone by a clinical research assistant to answer the CRIES 13 questionnaire.
In large families, the CRIES-13 of the holder of parental authority and of the child will be applied for each of them whose age corresponds to the inclusion criteria.
| Study group | Role | What they receive |
|---|---|---|
| children between 8 and 15 years old | answer to the CRIES 13 questionnaire Receives: Other: cries 13 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs of post traumatic stress disorder
Using a simple score (Child Revised Impact of Event Scale (CRIES-13)), determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start10 Jun 2020
- Primary completion2 Jul 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 703 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Claudet, Pr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615195
- Sponsor's protocol ID
- RC31/20/0205
- Acronym
- E-COCCON
- Status last verified
- Oct 2022
- First submitted
- 3 Nov 2020
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Claudet I, Marchand-Tonel C, Ricco L, Houze-Cerfon CH, Lang T, Brehin C. During the COVID-19 Quarantine, Home Has Been More Harmful Than the Virus for Children! Pediatr Emerg Care. 2020 Sep;36(9):e538-e540. doi: 10.1097/PEC.0000000000002205. No abstract available.
PubMed 32868552Claudet I, Marchand-Tonel C, Kelly-Irving M, Gaudron CZ, Raynaud JP, Delpierre C, Brehin C. The psychological effects of COVID-19-related containment in children: The E-COCCON French study. Arch Pediatr. 2022 Apr;29(3):188-193. doi: 10.1016/j.arcped.2022.01.011. Epub 2022 Jan 19.
PubMed 35115219
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COVID-19 Related COntainment in ChildreN
- ClinicalTrials.gov ID
- NCT04615195
- Acronym / sponsor ID
- E-COCCON / RC31/20/0205
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 703 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 4 Nov 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 current pandemic situation (SRAS COV2) is an unprecedented event and a source of stress potentially aggravated by containment. The Child Revised Impact Event Scale (CRIES-13) was evaluated in children 8 years or older in survivors of traumatic events, flood, stay in intensive care, or war (Bosnia). In this study CRIES-13 will be used to determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020
Detailed description
Parents of children aged 8 to 15 will be approached from different levels / places of selection / recruitment. A clinical researcher of pediatric clinical investigation center will collect the responses.
If one of the holders of parental authority and the child agree to participate, an information notice will be sent to them, then they will be contacted by telephone by a clinical research assistant to answer the questionnaire.
In large families, the CRIES-13 of the holder of parental authority and of the child will be applied for each of them whose age corresponds to the inclusion criteria.
The duration of the study / participant call and effective response to the questionnaire by the holder of parental authority and the child will takes a maximum of 20 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children between 8 and 15 years old | – | Other: cries 13 questionnaireanswer to the CRIES 13 questionnaire |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- All children aged between 8 and 15 accepting to participate and whose parents accepting to particpate
Key inclusion criteria (1 listed)
- Binomial of child (aged between 8 and 15) and one of its holders of parental authority agreeing to participate
Key exclusion criteria (4 listed)
- children aged under 8 and over 15
- children whose parents are opposed
- children refusing to participate
- holders of minor parental authority
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 |
|---|---|---|
| cries 13 questionnaireParticipant will be contacted by telephone by a clinical research assistant to answer the CRIES 13 questionnaire. In large families, the CRIES-13 of the holder of parental authority and of the child will be applied for each of them whose age corresponds to the inclusion criteria. | Other | children between 8 and 15 years old |
Primary outcome
Signs of post traumatic stress disorder
Time frame: 1 month
Using a simple score (Child Revised Impact of Event Scale (CRIES-13)), determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020
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 14 Oct 2022.
- Results publication: PubMed 32868552Claudet I, Marchand-Tonel C, Ricco L, Houze-Cerfon CH, Lang T, Brehin C. During the COVID-19 Quarantine, Home Has Been More Harmful Than the Virus for Children! Pediatr Emerg Care. 2020 Sep;36(9):e538-e540. doi: 10.1097/PEC.0000000000002205. No abstract available.
- Results publication: PubMed 35115219Claudet I, Marchand-Tonel C, Kelly-Irving M, Gaudron CZ, Raynaud JP, Delpierre C, Brehin C. The psychological effects of COVID-19-related containment in children: The E-COCCON French study. Arch Pediatr. 2022 Apr;29(3):188-193. doi: 10.1016/j.arcped.2022.01.011. Epub 2022 Jan 19.
- 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.
Isabelle Claudet, Pr principal investigator
University Hospital, Toulouse
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 Post Traumatic Stress Disorder, run by University Hospital, Toulouse 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 1 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 14 Oct 2022. 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?
Signs of post traumatic stress disorder (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04615195, which also lists 2 linked publications.
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 14 Oct 2022.