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

Study acronym: Program14-7
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 3600 to confirmed 728
    • Study sites: 4 to 1
    v8
  2. Interventions: Child and adolescent psychiatry and Epidemiology (Behavioral), qualitative analysis of the discourse (Behavioral), salivary biological… to Child and adolescent psychiatry and Epidemiology (Behavioral), Cognitive alterations (Behavioral), Impact on schooling (Behavioral)…
    • Secondary endpoints: 26 to 30
    • Study description expanded, about 120 words
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Secondary endpoints: 23 to 26
    • Study description expanded, about 178 words
    v5
  5. 2 versions Re-verified since Feb 25, 2019, no change to tracked fieldsv3-v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 3 to 4
    • Start date changed from estimate of Dec 2017 to Nov 21, 2017
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03356028
Lead Sponsor Fondation Lenval
Conditions
(from sponsor)		 Psychiatric Disorder, Trauma, Psychological
Related terms Mental Disorders, Psychological Trauma, Wounds and Injuries
Enrollment 728 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov