MFAE-ND: Mid-Term Follow-up Assessment After Exposure to Natural Disaster

Sponsor
Fondation Lenval (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05473962
Collaborator
(none)
116
1
5.9
19.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: assessment and quantification of symptoms related to post-traumatic stress.

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.,

  1. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
116 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Mid-Term Follow-up Assessment After Exposure to Natural Disaster
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.
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).

Outcome Measures

Primary Outcome Measures

  1. diagnostic criteria for post-traumatic stress disorder [at inclusion]

    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

Secondary Outcome Measures

  1. intensity of the symptoms [at inclusion]

    The intensity of the symptoms of this PTSD will be assessed by the Young Child PTSD checklist (YCPC) 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) These scales aim to screen for post-traumatic stress disorder symptoms in children aged 1 to 6 years old, by evaluating traumatic exposures (13 items), symptoms presented by the child (23 items) and his level of impairment or functional impairment (6 items). Items 14 to 36 relate to symptoms of PTSD and are based on a 5-points Likert scale, each item is scored from 0 to 4, the YCPC has a score ranging from 0 to 92. The diagnosis Cutoff is at 26 or more for items 14-36, it indicates a "probable diagnosis" of PTSD.

  2. assessment of somatization [at inclusion]

    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 Thirteen items, each of which is scored 0 to 2, providing a 0 to 30 severity score.

  3. Parental Stress [at inclusion]

    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 The "Parental Stress Index Short Form" is a self-assessment intended for the child's parent The PSI-SF has 36 items from the original 120-item PSI and based on a 5-points Likert scale, each item is scored from 1 to 5, the PSI-SF has a score ranging from 36 to 180. Percentile scores are used to interpret the scores. Scores at or above the 85th percentile are considered high (normal range : 15th-80th percentile

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopitaux Pediatriques de Nice Chu-Lenval Nice France

Sponsors and Collaborators

  • Fondation Lenval

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Lenval
ClinicalTrials.gov Identifier:
NCT05473962
Other Study ID Numbers:
  • 22-HPNCL-02
First Posted:
Jul 26, 2022
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondation Lenval
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022