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Pedopsychiatric and Multidisciplinary Research Devoted to Children Exposed to the Attack in Nice on July 14, 2016 (Program14-7)

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ClinicalTrials.gov Identifier: NCT03356028
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Lenval

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.


Condition or disease Intervention/treatment Phase
Psychiatric Disorder Trauma, Psychological Behavioral: Child and adolescent psychiatry and Epidemiology Other: salivary biological collection Behavioral: qualitative analysis of the discourse Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Interventional research involving the category 2 human person at minimal risk and constraint, excluding health product, multicentre
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : December 2044
Estimated Study Completion Date : December 2044

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
impacted by the attack of 14 July 2016
characterize the psycho-social factors of risk and / or protection interfering in the children's future with questionnaire following the mass trauma of 14 July 2016 in Nice on a sample of exposed pediatric population
Behavioral: Child and adolescent psychiatry and Epidemiology
psychosocial risk assessment questionnaire, structured diagnostic interview, pedopsychiatric questionnaire

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

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

control group
characterize the psycho-social factors of risk and / or protection interfering in the children's future with questionnaire of children controls
Behavioral: Child and adolescent psychiatry and Epidemiology
psychosocial risk assessment questionnaire, structured diagnostic interview, pedopsychiatric questionnaire




Primary Outcome Measures :
  1. psychosocial risk assessment questionnaire after 2 year [ Time Frame: Difference between baseline and after 2 year ]
    Completion of the psychosocial risk assessment questionnaire


Secondary Outcome Measures :
  1. psychosocial risk assessment questionnaire after 5 year [ Time Frame: Difference between baseline and after 5 year ]
    Completion of the psychosocial risk assessment questionnaire

  2. psychosocial risk assessment questionnaire after 10 year [ Time Frame: Difference between baseline and after 10 year ]
    Completion of the psychosocial risk assessment questionnaire

  3. psychosocial risk assessment questionnaire after 15 year [ Time Frame: Difference between baseline and after 15 year ]
    Completion of the psychosocial risk assessment questionnaire

  4. psychosocial risk assessment questionnaire after 20 year [ Time Frame: Difference between baseline and after 20 year ]
    Completion of the psychosocial risk assessment questionnaire

  5. psychosocial risk assessment questionnaire after 25 year [ Time Frame: Difference between baseline and after 25 year ]
    Completion of the psychosocial risk assessment questionnaire

  6. Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 2 year [ Time Frame: Difference between baseline and after 2 year ]
    Completion of the MINI questionnaire

  7. Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 5 year [ Time Frame: Difference between baseline and after 5 year ]
    Completion of the MINI questionnaire

  8. Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 10 year [ Time Frame: Difference between baseline and after 10 year ]
    Completion of the MINI questionnaire

  9. Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 15 year [ Time Frame: Difference between baseline and after 15 year ]
    Completion of the MINI questionnaire

  10. Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 20 year [ Time Frame: Difference between baseline and after 20 year ]
    Completion of the MINI questionnaire

  11. Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 25 year [ Time Frame: Difference between baseline and after 25 year ]
    Completion of the MINI questionnaire

  12. Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 2 year [ Time Frame: Difference between baseline and after 2 year ]
    Completion of the CGI-S

  13. Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 5 year [ Time Frame: Difference between baseline and after 5 year ]
    Completion of the CGI-S

  14. Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 10 year [ Time Frame: Difference between baseline and after 10 year ]
    Completion of the CGI-S

  15. Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 15 year [ Time Frame: Difference between baseline and after 15 year ]
    Completion of the CGI-S

  16. Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 20 year [ Time Frame: Difference between baseline and after 20 year ]
    Completion of the CGI-S

  17. Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 25 year [ Time Frame: Difference between baseline and after 25 year ]
    Completion of the CGI-S

  18. General operation CGA-S (Children's Global Assessment Scale) after 2 year [ Time Frame: Difference between baseline and after 2 year ]
    Completion of the CGA-S

  19. General operation CGA-S (Children's Global Assessment Scale) after 5 year [ Time Frame: Difference between baseline and after 5 year ]
    Completion of the CGA-S

  20. General operation CGA-S (Children's Global Assessment Scale) after 10 year [ Time Frame: Difference between baseline and after 10 year ]
    Completion of the CGA-S

  21. General operation CGA-S (Children's Global Assessment Scale) after 15 year [ Time Frame: Difference between baseline and after 15 year ]
    Completion of the CGA-S

  22. General operation CGA-S (Children's Global Assessment Scale) after 20 year [ Time Frame: Difference between baseline and after 20 year ]
    Completion of the CGA-S

  23. General operation CGA-S (Children's Global Assessment Scale) after 25 year [ Time Frame: Difference between baseline and after 25 year ]
    Completion of the CGA-S



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356028


Contacts
Contact: Florence ASKENAZY, MD +33(0)492030439 askenazy.f@pediatrie-chulenval-nice.fr
Contact: Gindt MORGANE +33(0)492030439 gindt.m@pediatrie-chulenval-nice.fr

Locations
France
CHU Avicenne Not yet recruiting
Bobigny, France, 93009
Contact: Thierry BAUDET, MD    +33(0)148955475    thierry.baudet@aphp.fr   
Principal Investigator: Thierry BAUDET, MD         
CHU de Caen Not yet recruiting
Caen, France, 14033
Contact: francis MD EUSTACHE, MD    +33(0)231973658    francis.eustache@unicaen.fr   
Principal Investigator: francis EUSTACHE, MD         
Hôpitaux pédiatriques de Nice CHU-Lenval Recruiting
Nice, France, 06200
Contact: Morgane GINDT    +33(0)492030439    gindt.m@pediatrie-chulenval-nice.fr   
Principal Investigator: Florence ASKENAZY, Pr         
CHU de Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Jean Philippe RAYNAUD, MD    +33(0)561777874    raynaud.jph@chu-toulouse.fr   
Principal Investigator: Jean Philippe RAYNAUD, MD         
Sponsors and Collaborators
Fondation Lenval
Investigators
Principal Investigator: Florence ASKENAZY, MD Hôpitaux Pédiatriques de Nice CHU-LENVAL

Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT03356028     History of Changes
Other Study ID Numbers: 17-HPNCL-03
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondation Lenval:
Trauma
Psychiatric Disorder
mass trauma

Additional relevant MeSH terms:
Mental Disorders
Problem Behavior
Psychological Trauma
Behavioral Symptoms
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders