Clinical trial NCT03356028: Pedopsychiatric and Multidisciplinary Research Devoted to Children Exposed to the Attack in Nice on July 14, 2016
Official title: Pedopsychiatric and Multidisciplinary Research (Public Health, Psychodynamics, Neuroscience and Human and Social Sciences) Devoted to Children Exposed to the Attack in Nice on July 14, 2016
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychiatric Disorder
Trauma, Psychological
Keywords: Trauma
Psychiatric Disorder
mass trauma
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 728
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional research involving the category 2 human person at minimal risk and constraint, excluding health product, multicentre
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: On July 14, 2016, in Nice, children and their families were attacked by the organization "EI". This is the second time in our country that children are victims of this organization after the attack on the school Ozar Hotarah in March 2012 in Toulouse where four children were killed "touching end".

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). This pathology includes 4 main symptoms: the reviviscences of the event, avoidance behaviors, alterations of cognition and mood and neurovegetative overactivation. In addition, PTSD contributes to the development of many other mental disorders. It is estimated that 75% of adolescents or children having a comorbid disorder with PTSD. In the literature, the main comorbidities identified in pediatric populations are: anxiety disorders, Attention Deficit Hyperactivity Disorder (ADHD) and depression. There is no recommendation as to the therapeutics to be used in psychotraumatism in pediatric population. Epidemiological studies conducted on the consequences of trauma reveal a high variability in the development of psychopathologies. 6 to 20% of exposed children would develop PTSD after a potentially traumatic situation. Several factors can explain the heterogeneity of the results, including the age, the type of trauma experienced, the violence suffered during this trauma. In Nice, to date, more than 2200 children have consulted: 700 children between July 14 and July 28, 2016, 1100 children were seen between August and December, and about 400 since the creation of the Post Traumatic Pediatric Intersectoral Assessment Center (CE2P), in January 2017. 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.

Non-psychotic hallucinations represent a significant symptomatology in child psychiatry (1) and remain clinical question. The results of our previous study "the physalis child" showed a significant correlation between the persistence of non-psychotic acousto-verbal hallucinations (AVH) and the presence of negative emotions, linked to post traumatic stress disorder (PTSD). It seems important to understand the link between trauma and the presence of non-psychotic AVH in children as the literature shows the risk of progression to psychosis when these AVH persist.The interest of the ancllary study of "the physalis child" would be to prospectively observe the presence or not of non-psychotic AVH in the population with PTSD from the "Program 14-7". The question would then be: "Why in two subjects diagnosed with PTSD, one has non-psychotic HAV and the other does not?" 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.

The impending opening of the trial of the 14 July attack, the conduct and the media coverage associated with the trial are all factors that could be distressing for the children and families exposed to the attack in Nice. Re-exposure to testimonials and certain images can increase the risk of traumatic reactivation with a return of suppressed fears and the symptoms associated. Some factors have been identified as protective: social and family support, cognitive functioning, the presence of residual symptoms or the quality of sleep.

Therefore, an assessment of these factors before and after the opening of the trial would identify children and families with traumatic reactivation, as well as identify protective or risk factors for relapse of traumatic symptoms

Eligibility criteria: 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 outcomes:
measure: psychosocial risk assessment questionnaire after 2 year
timeFrame: Difference between baseline and after 2 year
Secondary outcomes:
measure: psychosocial risk assessment questionnaire after 5 year
timeFrame: Difference between baseline and after 5 year
measure: psychosocial risk assessment questionnaire after 10 year
timeFrame: Difference between baseline and after 10 year
measure: psychosocial risk assessment questionnaire after 15 year
timeFrame: Difference between baseline and after 15 year
measure: psychosocial risk assessment questionnaire after 20 year
timeFrame: Difference between baseline and after 20 year
measure: psychosocial risk assessment questionnaire after 25 year
timeFrame: Difference between baseline and after 25 year
measure: Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 2 year
timeFrame: Difference between baseline and after 2 year
measure: Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 5 year
timeFrame: Difference between baseline and after 5 year
measure: Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 10 year
timeFrame: Difference between baseline and after 10 year
measure: Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 15 year
timeFrame: Difference between baseline and after 15 year
measure: Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 20 year
timeFrame: Difference between baseline and after 20 year
measure: Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 25 year
timeFrame: Difference between baseline and after 25 year
measure: Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 2 year
timeFrame: Difference between baseline and after 2 year
measure: Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 5 year
timeFrame: Difference between baseline and after 5 year
measure: Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 10 year
timeFrame: Difference between baseline and after 10 year
measure: Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 15 year
timeFrame: Difference between baseline and after 15 year
measure: Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 20 year
timeFrame: Difference between baseline and after 20 year
measure: Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 25 year
timeFrame: Difference between baseline and after 25 year
measure: General operation CGA-S (Children's Global Assessment Scale) after 2 year
timeFrame: Difference between baseline and after 2 year
measure: General operation CGA-S (Children's Global Assessment Scale) after 5 year
timeFrame: Difference between baseline and after 5 year
measure: General operation CGA-S (Children's Global Assessment Scale) after 10 year
timeFrame: Difference between baseline and after 10 year
measure: General operation CGA-S (Children's Global Assessment Scale) after 15 year
timeFrame: Difference between baseline and after 15 year
measure: General operation CGA-S (Children's Global Assessment Scale) after 20 year
timeFrame: Difference between baseline and after 20 year
measure: General operation CGA-S (Children's Global Assessment Scale) after 25 year
timeFrame: Difference between baseline and after 25 year
measure: identify factors of social cognition linked to the presence of non-psychotic acousto-verbal hallucinations (AVH)
timeFrame: at baseline
measure: identify factors of emotional cognition linked to the presence of non-psychotic AVH
timeFrame: at baseline
measure: identify the factors of persistence of AVH
timeFrame: after 6 months, 1 year and 2 year from baseline
measure: impact of trial of the attack July 14th on Parenthood
timeFrame: baseline and month9
measure: impact of trial of the attack July 14th on Cognitive alterations
timeFrame: baseline and month 6
measure: impact of trial of the attack July 14th on schooling
timeFrame: 2 years from baseline
measure: impact of trial of the attack July 14th on Sleep disorders and associated somatizations
timeFrame: baseline and month 6
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpitaux pédiatriques de Nice CHU-Lenval
Study officials:
affiliation: Hôpitaux Pédiatriques de Nice CHU-LENVAL
name: Florence ASKENAZY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gindt M, Thummler S, Soubelet A, Guenole F, Battista M, Askenazy F. Methodology of "14-7" Program: A Longitudinal Follow-Up Study of the Pediatric Population and Their Families Exposed to the Terrorist Attack of Nice on July 14th, 2016. Front Psychiatry. 2019 Sep 12;10:629. doi: 10.3389/fpsyt.2019.00629. eCollection 2019.