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

October 11, 2022 updated by: University Hospital, Toulouse
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

703

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • UHToulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 11 years (Child)

Accepts Healthy Volunteers

N/A

Genders 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Isabelle Claudet, Pr, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Actual)

July 2, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/20/0205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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