NCT04615195

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
703

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2020

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

22 days

First QC Date

November 3, 2020

Last Update Submit

October 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

children between 8 and 15 years old

answer to the CRIES 13 questionnaire

Other: cries 13 questionnaire

Interventions

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.

children between 8 and 15 years old

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All children aged between 8 and 15 accepting to participate and whose parents accepting to particpate

You may qualify if:

  • Binomial of child (aged between 8 and 15) and one of its holders of parental authority agreeing to participate

You may not qualify if:

  • children aged under 8 and over 15
  • children whose parents are opposed
  • children refusing to participate
  • holders of minor parental authority

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHToulouse

Toulouse, 31000, France

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Isabelle Claudet, Pr

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 4, 2020

Study Start

June 10, 2020

Primary Completion

July 2, 2020

Study Completion

September 30, 2020

Last Updated

October 14, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations