Effect of COVID-19 Related COntainment in ChildreN

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Other: cries 13 questionnaire

• Registration Number: NCT04615195
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2020-06-10
• Primary Completion: 2020-07-02
• Study Completion: 2020-09-30
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-11
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 703

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
children between 8 and 15 years old	cries 13 questionnaire	answer to the CRIES 13 questionnaire

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UHToulouse; 🇫🇷 Toulouse, France