NCT03356028

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. 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 Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
728

participants targeted

Target at P75+ for not_applicable

Timeline
226mo left

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Nov 2017Dec 2044

First Submitted

Initial submission to the registry

November 9, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
27 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2044

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2044

Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

27 years

First QC Date

November 9, 2017

Last Update Submit

September 28, 2023

Conditions

Psychiatric DisorderTrauma, Psychological

Keywords

TraumaPsychiatric Disordermass trauma

Outcome Measures

Primary Outcomes (1)

  • psychosocial risk assessment questionnaire after 2 year

    Completion of the psychosocial risk assessment questionnaire

    Difference between baseline and after 2 year

Secondary Outcomes (30)

  • psychosocial risk assessment questionnaire after 5 year

    Difference between baseline and after 5 year

  • psychosocial risk assessment questionnaire after 10 year

    Difference between baseline and after 10 year

  • psychosocial risk assessment questionnaire after 15 year

    Difference between baseline and after 15 year

  • psychosocial risk assessment questionnaire after 20 year

    Difference between baseline and after 20 year

  • psychosocial risk assessment questionnaire after 25 year

    Difference between baseline and after 25 year

  • +25 more secondary outcomes

Study Arms (2)

impacted by the attack of 14 July 2016

OTHER

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 EpidemiologyOther: salivary biological collectionBehavioral: qualitative analysis of the discourseBehavioral: ParenthoodBehavioral: Cognitive alterationsBehavioral: Impact on schoolingBehavioral: Sleep disorders and associated somatizations

control group

OTHER

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

Interventions

Child and adolescent psychiatry and EpidemiologyBEHAVIORAL

psychosocial risk assessment questionnaire, structured diagnostic interview, pedopsychiatric questionnaire

control groupimpacted by the attack of 14 July 2016
salivary biological collectionOTHER

Saliva sampling will be done using a specific kit

impacted by the attack of 14 July 2016
qualitative analysis of the discourseBEHAVIORAL

two semi-structured interviews, the first with the teenager alone, the second with the lone parents

impacted by the attack of 14 July 2016
ParenthoodBEHAVIORAL

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

impacted by the attack of 14 July 2016
Cognitive alterationsBEHAVIORAL

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

impacted by the attack of 14 July 2016
Impact on schoolingBEHAVIORAL

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

impacted by the attack of 14 July 2016
Sleep disorders and associated somatizationsBEHAVIORAL

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

impacted by the attack of 14 July 2016

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).
  • Children and / or young adults with average intellectual disability (Intelligence Quotient IQ less than 50);
  • Person deprived of liberty by judicial or administrative decision;

You may not qualify if:

  • a simple request from the child / adolescent and / or young adults or their parents (interruption of participation or withdrawal of consent);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux pédiatriques de Nice CHU-Lenval

Nice, 06200, France

Location

Related Publications (3)

  • Dumas LE, Askenazy F, Fernandez A. Relationships between markers of emotional and social cognition and acoustic-verbal hallucinations in children and adolescents with post-traumatic stress disorder (PTSD). PLoS One. 2025 Sep 23;20(9):e0332910. doi: 10.1371/journal.pone.0332910. eCollection 2025.

    PMID: 40986567DERIVED

  • Dumas LE, Fernandez A, Auby P, Askenazy F. Relationship between social cognition and emotional markers and acoustic-verbal hallucination in youth with post-traumatic stress disorder: Protocol for a prospective, 2-year, longitudinal case-control study. PLoS One. 2024 Jul 2;19(7):e0306338. doi: 10.1371/journal.pone.0306338. eCollection 2024.

    PMID: 38954699DERIVED

  • Gindt M, Thummler S, Soubelet A, Guenole F, Battista M, Askenazy F. Methodology of "14-7" Program: A Longitudinal Follow-Up Study of the Pediatric Population and Their Families Exposed to the Terrorist Attack of Nice on July 14th, 2016. Front Psychiatry. 2019 Sep 12;10:629. doi: 10.3389/fpsyt.2019.00629. eCollection 2019.

    PMID: 31572232DERIVED

MeSH Terms

Conditions

Mental DisordersPsychological TraumaWounds and Injuries

Interventions

Adolescent Psychiatry

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

PsychiatryBehavioral SciencesBehavioral Disciplines and Activities

Study Officials

  • Florence ASKENAZY, MD

    Hôpitaux Pédiatriques de Nice CHU-LENVAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Interventional research involving the category 2 human person at minimal risk and constraint, excluding health product, multicentre
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 29, 2017

Study Start

November 21, 2017

Primary Completion (Estimated)

December 1, 2044

Study Completion (Estimated)

December 1, 2044

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)