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

NCT03356028 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 728

Last updated 2023-09-29

No results posted yet for this study

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.

Conditions

  • Psychiatric Disorder
  • Trauma, Psychological

Interventions

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

BEHAVIORAL

Parenthood

Parenting Sense of Competence (PSOC) questionnaires completed online.Two visits will be realized: a first in the month preceding the start of the trial and a second in the month following the end of the trial

BEHAVIORAL

Cognitive alterations

Episodic memory will be assessed using Grober and Buschke. The evaluation of the cognitive alterations will include two stages: a first in the month preceding the start of the trial and a second in the month following the end of the trial. For child and parents

BEHAVIORAL

Impact on schooling

collect of several data about the number of absences of the child, the number of exclusions and hours of detention of the child, as well as the school reports of the child

BEHAVIORAL

Sleep disorders and associated somatizations

Evaluation of sleep disorders and associated somatizations by connected watche and sleep questionnaire

Sponsors & Collaborators

  • Fondation Lenval

    lead OTHER

Principal Investigators

  • Florence ASKENAZY, MD · Hôpitaux Pédiatriques de Nice CHU-LENVAL

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-21
Primary Completion
2044-12-31
Completion
2044-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03356028 on ClinicalTrials.gov