NCT05473962

Brief Summary

The present study proposes to carry out an evaluation of the children of adolescents who were seen by the teams of the Cellules d'Urgence Médico-Psychologique (CUMP) following the Alex storm in October 2020. A clinical child psychiatric and psychological evaluation will be carried out, with collection of socio-demographic data

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 12, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
Last Updated

September 29, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

July 22, 2022

Last Update Submit

September 28, 2023

Conditions

Keywords

Post-traumatic stress disorder (PTSD)

Outcome Measures

Primary Outcomes (1)

  • diagnostic criteria for post-traumatic stress disorder

    Semi-structured interview based on the Clinician-Administered PTSD scale for DSM-5 Child/Adolescent -CAPS-CA-5. This instrument allows for the This instrument is validated in English, and a French translation was carried out by the investigators (translation/back-translation method). The instrument uses the DSM-5 diagnostic criteria for post-traumatic stress disorder (PTSD). This tool as 517 items. This scale doesn't work on numerical values (there is no min, max or cut scores), this scale makes it possible to confirm or invalidate the presence of symptoms necessary for establishing diagnoses on Diagnosis and Statistical Manual of Mental Disorders (DSMV) criteria

    at inclusion

Secondary Outcomes (3)

  • intensity of the symptoms

    at inclusion

  • assessment of somatization

    at inclusion

  • Parental Stress

    at inclusion

Study Arms (1)

exposed to Alex storm

Child and/or young adult aged under 18 at the time of exposure having been assessed by the CUMPS teams during the "ALEX Storm" interventions of October 2020

Diagnostic Test: assessment and quantification of symptoms related to post-traumatic stress.

Interventions

Semi-structured interview based on the Clinician-Administered PTSD scale for DSM-5 Child/Adolescent -CAPS-CA-5. This instrument allows for the This instrument is validated in English, and a French translation was carried out by the investigators (translation/back-translation method). The instrument uses the DSM-5 diagnostic criteria for post-traumatic stress disorder (PTSD).

exposed to Alex storm

Eligibility Criteria

AgeUp to 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children of adolescents who were seen by the teams of the Cellules d'Urgence Médico-Psychologique (CUMP) following the Alex storm in October 2020.

You may qualify if:

  • Child and/or young adult aged under 18 at the time of exposure having been assessed by the CUMPS teams during the "ALEX Storm" interventions of October 2020
  • Affiliated to a social security scheme
  • Children whose parents have accepted participation in the study and/or young adults who have accepted participation in the study (collection of non-objection

You may not qualify if:

  • Children and/or young adults with a severe somatic and/or psychiatric disorder that makes assessment impossible or may alter emotional regulation behavior.
  • Non-participation in a parallel study that could modify emotional regulation behavior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopitaux Pediatriques de Nice Chu-Lenval

Nice, France

Location

MeSH Terms

Conditions

Mental DisordersStress Disorders, Post-Traumatic

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

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

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 26, 2022

Study Start

October 12, 2022

Primary Completion

May 20, 2023

Study Completion

May 20, 2023

Last Updated

September 29, 2023

Record last verified: 2023-03

Locations