E-COCCON: Effect of COVID-9 Related COntainment in ChildreN

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Completed

CT.gov ID

NCT04615195

Collaborator

(none)

703

Enrollment

Location

3.7

Actual Duration (Months)

191

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

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 :

Jun 10, 2020

Actual Primary Completion Date :

Jul 2, 2020

Actual Study Completion Date :

Sep 30, 2020

Arms and Interventions

Arm	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.

Arm

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

Primary Outcome Measures

Signs of post traumatic stress disorder [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

Criteria

Ages Eligible for Study:

8 Years to 15 Years

Sexes Eligible for Study:

All

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

Locations

	Site	City	State	Country	Postal Code
1	UHToulouse	Toulouse		France	31000

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Isabelle CLAUDET, Pr, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT04615195

Other Study ID Numbers:

RC31/20/0205

First Posted:

Nov 4, 2020

Last Update Posted:

Aug 27, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Aug 27, 2021