Effect of COVID-19 Related COntainment in ChildreN

NCT ID: NCT04615195

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

703 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-10

Study Completion Date

2020-09-30

Brief Summary

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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

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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

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Post Traumatic Stress Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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children between 8 and 15 years old

answer to the CRIES 13 questionnaire

cries 13 questionnaire

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle Claudet, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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UHToulouse

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 32868552 (View on PubMed)

Claudet 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.

Reference Type RESULT
PMID: 35115219 (View on PubMed)

Other Identifiers

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RC31/20/0205

Identifier Type: -

Identifier Source: org_study_id

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