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Clinical Trials/NCT04615195
NCT04615195
Completed
Not Applicable

Effect of COVID-19 Related COntainment in ChildreN

University Hospital, Toulouse1 site in 1 country703 target enrollmentJune 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Traumatic Stress Disorder
Sponsor
University Hospital, Toulouse
Enrollment
703
Locations
1
Primary Endpoint
Signs of post traumatic stress disorder
Status
Completed
Last Updated
3 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2020
End Date
September 30, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (1)

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