Clinical trial NCT05473962: Mid-Term Follow-up Assessment After Exposure to Natural Disaster
Official title: Mid-Term Follow-up Assessment After Exposure to Natural Disaster
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Disorder
Keywords: Post-traumatic stress disorder (PTSD)
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 55
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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

Detailed description: Description: Assessment 24 months after exposure to a natural disaster of the clinical condition of children and adolescents cared for by medical-psychological emergency teams (CUMP) by measuring the frequency of clinical disorders and the intensity of symptoms and by comparing their clinical condition to that assessed immediately after exposure.

* Primary endpoint:

Semi-structured interview based on the Clinician-Administered PTSD scale for DSM-5 Child/Adolescent -CAPS-CA-5. This instrument allows for the assessment and quantification of symptoms related to post-traumatic stress. 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).

* Secondary endpoints:
* The intensity of the symptoms of this PTSD will be assessed by the Young Child PTSD checklist (YCPC) (Scheeringa, 2013; translation of the French version: Thümmler et al., 2017) for young children under the age of 7. For children over 7 years of age, it will be assessed by the Child PTSD checklist, child version (CPC) (Scheeringa, 2014; translation and validation of the French version: Gindt et al., 2020).
* Patient Health Questionnaire 13 items (PQH13). This simple and quick to use instrument allows a systematic assessment of somatization in children. This questionnaire will be offered to parents of children under 7 years of age as a hetero-assessment and directly to children over 7 years of age as a selfassessment.
* Parental Stress Index - Short Form (PSI-SF): Short version of the Parental Stress Index. The instrument will be offered to parents of study participants in self-report. It evaluates the magnitude of stress in the parent-child system.

Interventions :

The study has two phases:

The clinician-led interview will be conducted with the parent(s) or directly with the child in a face-to-face or remote setting.

-The scales will be validated via an online platform. An initial analysis of the general data (primary and secondary criteria) will be carried out using various descriptive statistics indicators. Depending on the participation rate in the study and the total number of participants, a general linear model analysis will be performed on the different indicators collected (presence/absence of the different symptoms, and scores on the different instruments) in order to describe the evolution of the children's symptoms. The data collected in this study will then be compared to the initial post-exposure assessment.

Duration: The estimated duration of the study is one year (including analyses). Participation in the inclusion period is six months. The duration of participation per person in the study will be 30 minutes of interview + 20 minutes of delivery of psychological instruments.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: diagnostic criteria for post-traumatic stress disorder
timeFrame: at inclusion
Secondary outcomes:
measure: intensity of the symptoms
timeFrame: at inclusion
measure: assessment of somatization
timeFrame: at inclusion
measure: Parental Stress
timeFrame: at inclusion
Other outcomes:
Locations:
city: Nice
country: France
facility: Hopitaux Pediatriques de Nice Chu-Lenval
Study officials:
References: