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OpenTrials
Completed

NCT Number: NCT04615195

Effect of COVID-19 Related COntainment in ChildreN

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

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Key information

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UHToulouse

Toulouse, 31000, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cries 13 questionnaire

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: E-COCCON

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 4, 2020
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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