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Effect of COVID-19 Related COntainment in ChildreN (E-COCCON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04615195
Recruitment Status : Completed
First Posted : November 4, 2020
Last Update Posted : October 14, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief 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). 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

Condition or disease Intervention/treatment
Post Traumatic Stress Disorder Other: cries 13 questionnaire

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
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Study Type : Observational
Actual Enrollment : 703 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of COVID-19 Related COntainment in ChildreN
Actual Study Start Date : June 10, 2020
Actual Primary Completion Date : July 2, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
children between 8 and 15 years old
answer to the CRIES 13 questionnaire
 Other: cries 13 questionnaire

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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All children aged between 8 and 15 accepting to participate and whose parents accepting to particpate
Criteria

Inclusion Criteria:

  • Binomial of child (aged between 8 and 15) and one of its holders of parental authority agreeing to participate

Exclusion Criteria:

  • children aged under 8 and over 15
  • children whose parents are opposed
  • children refusing to participate
  • holders of minor parental authority
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04615195


Locations
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France
UHToulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Isabelle Claudet, Pr University Hospital, Toulouse
More Information
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Publications of Results:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04615195    
Other Study ID Numbers: RC31/20/0205
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders