Study Protocol ARTICLE
“14-7” Program: a longitudinal follow-up study of the paediatric population and their families exposed to the terrorist attack of Nice on July 14th, 2016.
- 1Hôpitaux Pédiatriques de Nice CHU-Lenval, France
- 2Université Côte d'Azur, France
- 3Centre Hospitalier Universitaire de Caen, France
After a traumatic event, children and adolescents may present several clinical consequences, the most common being Post-Traumatic Stress Disorder (PTSD). Most children and adolescents with PTSD have comorbid disorders, such Attention Deficit Hyperactivity Disorder, depression, attachment and anxiety disorders, sleep disturbances and behaviour problems.
However, epidemiological studies on the development of PTSD and other psychiatric disorders in children and adolescents as a consequence of a terrorist attack and mass murder are lacking. Long-term follow-up of exposed children and adolescents will help identify risk and protective factors of developing psychiatric and psychological conditions after exposure to traumatic events or situations.
The main objective of this article is to present the methodology of ‘14-7’ program. The aim of ‘14-7’ program is to characterize the risk and protective psychosocial factors affecting the clinical evolution of a paediatric population sample, exposed to the terrorist attack of July 14th, 2016 in Nice.
Method and analysis:
’14-7’ program is a multicentre longitudinal cohort study. Major inclusion criteria are children and adolescents exposed to the terrorist attack and aged under 18 years on July 14th, 2016. These children and adolescents will be compared to a non-exposed to the “14-7” terrorist attack group, matched on age and gender.
Participants will be assessed at baseline (T1), 2 years (T2) and five years (T3) after the initial assessment (T1), and every five years until they are 25 years old. Multiple domains are assessed : (1) mental health disorders, (2) intensity of PTSD symptoms, (3) intensity of comorbid symptoms, (4) quality of the parent–child relationship, (5) intelligence quotient, (6) parental symptoms. We will also establish a biological collection of saliva samples, Magnetic Resonance Imaging (MRI) and actigraphy data collection.
Main analyses comprise analyses of variance and regression analyses of predictors of clinical evolution over time.
Ethics and dissemination: The National Ethics Committee ‘NORD OUEST III’ approved the “14-7” Program protocol (number 2017-A02212-51). All patients and their caregivers signed informed consent on enrolment in the “14-7” Program. Inclusions started on November 21st, 2017. 335 individuals have been included (191 children and adolescents, 144 parents).
Trial registration number: NCT03356028
Keywords: Post-traumatic stress disorder, Children, Longitudinal Studies, cohort, Psychiatry
Received: 29 May 2019;
Accepted: 05 Aug 2019.
Copyright: © 2019 Gindt, Thümmler, Soubelet, Guénolé, Battista and Askenazy. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: PhD. Morgane Gindt, Hôpitaux Pédiatriques de Nice CHU-Lenval, Nice, France, email@example.com