Clinical Trial

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

Study acronym: Program14-7
Active, Not Recruiting
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2017-11-22; most recent amendment 2023-09-28.
Status change: Recruiting → Active, Not Recruiting 2023-09-28
Status change: Not Yet Recruiting → Recruiting 2018-04-20
Trial Details
NCT Number NCT03356028
Lead Sponsor Fondation Lenval
Conditions Psychiatric Disorder, Trauma, Psychological
Enrollment 728 participants
Start Date 2017-11-21
Primary Completion 2044-12 (estimated)
Study Completion 2044-12 (estimated)
Updated on ClinicalTrials.gov 2023-09-29