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Clinical Trials in France / NCT03356028
Active, not recruiting Not applicable

Pedopsychiatric and Multidisciplinary Research Devoted to Children Exposed to the Attack in Nice on July 14, 2016

NCT03356028 · tracked via the Priya Life Science France tracker
Sponsor
Fondation Lenval
Phase
Not applicable
Started
2017-11-21
Last updated
2023-09-29

Condition(s) studied

Psychiatric DisorderTrauma, Psychological

Investigational drug(s) / intervention(s)

Child and adolescent psychiatry and Epidemiologysalivary biological collectionqualitative analysis of the discourseParenthoodCognitive alterationsImpact on schoolingSleep disorders and associated somatizations

Child and adolescent psychiatry and Epidemiology: psychosocial risk assessment questionnaire, structured diagnostic interview, pedopsychiatric questionnaire

salivary biological collection: Saliva sampling will be done using a specific kit

qualitative analysis of the discourse: two semi-structured interviews, the first with the teenager alone, the second with the lone parents

Parenthood: Parenting Sense of Competence (PSOC) questionnaires completed online.Two visits will be realized: a first in the month preceding the start of the trial and a second in the month following the end of the trial

Cognitive alterations: Episodic memory will be assessed using Grober and Buschke. The evaluation of the cognitive alterations will include two stages: a first in the month preceding the start of the trial and a second in the month following the end of the trial. For child and parents

Impact on schooling: collect of several data about the number of absences of the child, the number of exclusions and hours of detention of the child, as well as the school reports of the child

Sleep disorders and associated somatizations: Evaluation of sleep disorders and associated somatizations by connected watche and sleep questionnaire

Study summary

On July 14, 2016, in Nice, children and their families were attacked by the organization "EI". In Nice, 86 deaths, including 10 children, the youngest at 4, were recorded. A number of children, still difficult to assess exactly but over 100, was bereaved.

After a traumatic event, multiple clinical consequences may appear in children. Among these consequences, the most common is Post-Traumatic Stress Disorder (PTSD). The aim of the study is to characterize the psycho-social factors of risk and / or protection interfering in the children's future, following the mass trauma of 14 July 2016 in Nice on a sample of pediatric population exposed in comparison of children controls.

Ancillary study, entilted "The Physalis Child", prospectively observe the presence or not of non-psychotic acousto-verbal hallucinations (AVH) in the population with PTSD from the "Program 14-7". The main objective of this ancillary study will be to identify factors of social and emotional cognition linked to the presence of non-psychotic HAV within the cohort of children exposed to the mass trauma of July 14, 2016 in Nice but also to any type of individual trauma.

Ancillary study, entilted "trail of the 14 July attack", prospectively observe the risk of traumatic reactivation.

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Children and / or young adults who have consulted at the pediatric consultation center of the CHU Lenval or who are listed in the ORSAN "organization of the health system response in exceptional health situations" file or who have made an appointment following the call by press; * Children and / or young adults under 18 at the time of the Nice attack of 14/07/2016. * Affiliated to a social security scheme; * Having a good command of the French language (French); * Children whose parents have accepted participation in the study (collection of informed consents). Non inclusion: * Children and / or young adults with average intellectual disability (Intelligence Quotient IQ less than 50); * Person deprived of liberty by judicial or administrative decision; * Person subject to an exclusion period for another search. Exclusion Criteria: * a simple request from the child / adolescent and / or young adults or their parents (interruption of participation or withdrawal of consent); * failure to comply with the instructions defined and exposed at the time of inclusion.

Primary outcome measure(s)

  • psychosocial risk assessment questionnaire after 2 year — Difference between baseline and after 2 year
    Completion of the psychosocial risk assessment questionnaire

Trial sites (1)

FacilityCityRegionStatus
Hôpitaux pédiatriques de Nice CHU-Lenval Nice France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03356028 on ClinicalTrials.gov ↗ ← All trials in France