Effect of COVID-19 Related COntainment in ChildreN

Post Traumatic Stress Disorder Clinical Trial

— E-COCCON  

Official title:

Effect of COVID-19 Related COntainment in ChildreN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04615195
• Other study ID #: RC31/20/0205
• Status: Completed
• Start date: June 10, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 703
• Est. completion date: September 30, 2020
• Est. primary completion date: July 2, 2020
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
France	UHToulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (2)

Claudet I, Marchand-Tonel C, Kelly-Irving M, Gaudron CZ, Raynaud JP, Delpierre C, Bréhin 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. — View Citation

Claudet I, Marchand-Tonel C, Ricco L, Houzé-Cerfon CH, Lang T, Bréhin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signs of post traumatic stress disorder	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	1 month