Psychiatric DisorderProgram14-7NCT03356028
Pedopsychiatric and Multidisciplinary Research Devoted to Children Exposed to the Attack in Nice on July 14, 2016
A study testing Child and adolescent psychiatry and Epidemiology, salivary biological collection and qualitative analysis of the discourse in people with Psychiatric Disorder and Trauma, Psychological, run by Fondation Lenval at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Disorder, Trauma, Psychological
- What is being tested?
- Child and adolescent psychiatry and Epidemiology, salivary biological collection and qualitative analysis of the discourse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 728 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2017to Dec 2044
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
- Non inclusion:
Show all 9Show fewer
- Children and / or young adults with average intellectual disability (Intelligence Quotient IQ less than 50);
- Person deprived of liberty by judicial or administrative decision;
- Person subject to an exclusion period for another search.
Who cannot join
- a simple request from the child / adolescent and / or young adults or their parents (interruption of participation or withdrawal of consent);
- failure to comply with the instructions defined and exposed at the time of inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pedopsychiatric and Multidisciplinary Research (Public Health, Psychodynamics, Neuroscience and Human and Social Sciences) Devoted to Children Exposed to the Attack in Nice on July 14, 2016
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.
Read more
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.
Read the detailed description
On July 14, 2016, in Nice, children and their families were attacked by the organization "EI". This is the second time in our country that children are victims of this organization after the attack on the school Ozar Hotarah in March 2012 in Toulouse where four children were killed "touching end".
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). This pathology includes 4 main symptoms: the reviviscences of the event, avoidance behaviors, alterations of cognition and mood and neurovegetative overactivation. In addition, PTSD contributes to the development of many other mental disorders. It is estimated that 75% of adolescents or children having a comorbid disorder with PTSD. In the literature, the main comorbidities identified in pediatric populations are: anxiety disorders, Attention Deficit Hyperactivity Disorder (ADHD) and depression. There is no recommendation as to the therapeutics to be used in psychotraumatism in pediatric population. Epidemiological studies conducted on the consequences of trauma reveal a high variability in the development of psychopathologies. 6 to 20% of exposed children would develop PTSD after a potentially traumatic situation. Several factors can explain the heterogeneity of the results, including the age, the type of trauma experienced, the violence suffered during this trauma. In Nice, to date, more than 2200 children have consulted: 700 children between July 14 and July 28, 2016, 1100 children were seen between August and December, and about 400 since the creation of the Post Traumatic Pediatric Intersectoral Assessment Center (CE2P), in January 2017. 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.
Non-psychotic hallucinations represent a significant symptomatology in child psychiatry (1) and remain clinical question. The results of our previous study "the physalis child" showed a significant correlation between the persistence of non-psychotic acousto-verbal hallucinations (AVH) and the presence of negative emotions, linked to post traumatic stress disorder (PTSD). It seems important to understand the link between trauma and the presence of non-psychotic AVH in children as the literature shows the risk of progression to psychosis when these AVH persist.The interest of the ancllary study of "the physalis child" would be to prospectively observe the presence or not of non-psychotic AVH in the population with PTSD from the "Program 14-7". The question would then be: "Why in two subjects diagnosed with PTSD, one has non-psychotic HAV and the other does not?" 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.
The impending opening of the trial of the 14 July attack, the conduct and the media coverage associated with the trial are all factors that could be distressing for the children and families exposed to the attack in Nice. Re-exposure to testimonials and certain images can increase the risk of traumatic reactivation with a return of suppressed fears and the symptoms associated. Some factors have been identified as protective: social and family support, cognitive functioning, the presence of residual symptoms or the quality of sleep.
Therefore, an assessment of these factors before and after the opening of the trial would identify children and families with traumatic reactivation, as well as identify protective or risk factors for relapse of traumatic symptoms
- Conditions
- Psychiatric Disorder, Trauma, Psychological
- Being tested
- Child and adolescent psychiatry and Epidemiology, salivary biological collection, qualitative analysis of the discourse, Parenthood, Cognitive alterations
- Keywords
- Trauma, Psychiatric Disorder, mass trauma
- Medical subject headings
- Mental Disorders, Psychological Trauma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child and adolescent psychiatry and EpidemiologyBehavioural
psychosocial risk assessment questionnaire, structured diagnostic interview, pedopsychiatric questionnaire
salivary biological collectionOther
Saliva sampling will be done using a specific kit
qualitative analysis of the discourseBehavioural
two semi-structured interviews, the first with the teenager alone, the second with the lone parents
ParenthoodBehavioural
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
Cognitive alterationsBehavioural
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
Impact on schoolingBehavioural
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
Sleep disorders and associated somatizationsBehavioural
Evaluation of sleep disorders and associated somatizations by connected watche and sleep questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Child and adolescent psychiatry and Epidemiology; Other: salivary biological collection; Behavioral: qualitative analysis of the discourse; Behavioral: Parenthood; Behavioral: Cognitive alterations; Behavioral: Impact on schooling; Behavioral: 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 Receives: Behavioral: Child and adolescent psychiatry and Epidemiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychosocial risk assessment questionnaire after 2 year
Completion of the psychosocial risk assessment questionnaire
Measured: Difference between baseline and after 2 year
Secondary outcomes (30)
psychosocial risk assessment questionnaire after 5 year
Completion of the psychosocial risk assessment questionnaire
Measured: Difference between baseline and after 5 year
psychosocial risk assessment questionnaire after 10 year
Completion of the psychosocial risk assessment questionnaire
Measured: Difference between baseline and after 10 year
psychosocial risk assessment questionnaire after 15 year
Completion of the psychosocial risk assessment questionnaire
Measured: Difference between baseline and after 15 year
psychosocial risk assessment questionnaire after 20 year
Completion of the psychosocial risk assessment questionnaire
Measured: Difference between baseline and after 20 year
psychosocial risk assessment questionnaire after 25 year
Completion of the psychosocial risk assessment questionnaire
Measured: Difference between baseline and after 25 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 2 year
Completion of the MINI questionnaire
Measured: Difference between baseline and after 2 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 5 year
Completion of the MINI questionnaire
Measured: Difference between baseline and after 5 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 10 year
Completion of the MINI questionnaire
Measured: Difference between baseline and after 10 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 15 year
Completion of the MINI questionnaire
Measured: Difference between baseline and after 15 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 20 year
Completion of the MINI questionnaire
Measured: Difference between baseline and after 20 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 25 year
Completion of the MINI questionnaire
Measured: Difference between baseline and after 25 year
Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 2 year
Completion of the CGI-S
Measured: Difference between baseline and after 2 year
Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 5 year
Completion of the CGI-S
Measured: Difference between baseline and after 5 year
Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 10 year
Completion of the CGI-S
Measured: Difference between baseline and after 10 year
Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 15 year
Completion of the CGI-S
Measured: Difference between baseline and after 15 year
Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 20 year
Completion of the CGI-S
Measured: Difference between baseline and after 20 year
Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 25 year
Completion of the CGI-S
Measured: Difference between baseline and after 25 year
General operation CGA-S (Children's Global Assessment Scale) after 2 year
Completion of the CGA-S
Measured: Difference between baseline and after 2 year
General operation CGA-S (Children's Global Assessment Scale) after 5 year
Completion of the CGA-S
Measured: Difference between baseline and after 5 year
General operation CGA-S (Children's Global Assessment Scale) after 10 year
Completion of the CGA-S
Measured: Difference between baseline and after 10 year
General operation CGA-S (Children's Global Assessment Scale) after 15 year
Completion of the CGA-S
Measured: Difference between baseline and after 15 year
General operation CGA-S (Children's Global Assessment Scale) after 20 year
Completion of the CGA-S
Measured: Difference between baseline and after 20 year
General operation CGA-S (Children's Global Assessment Scale) after 25 year
Completion of the CGA-S
Measured: Difference between baseline and after 25 year
identify factors of social cognition linked to the presence of non-psychotic acousto-verbal hallucinations (AVH)
completion of the NEPSY II for a complete neuropsychological assessment
Measured: at baseline
identify factors of emotional cognition linked to the presence of non-psychotic AVH
completion of the EED IV , French version of the Differential Emotions Scale IV (DES-IV
Measured: at baseline
identify the factors of persistence of AVH
complete neuropsychological assessment
Measured: after 6 months, 1 year and 2 year from baseline
impact of trial of the attack July 14th on Parenthood
Parenthood assessment will be offered to parents of children included in the arm "impacted by attack" The Parenting Sense of Competence (PSOC) questionnaire is a widely used scale to assess and measure parenting abilities perceived by parents with two subscales: competence/knowledge and appreciation/comfort.
The PSOC is a scale with a score ranging from 17 to 102. The higher the score, the more the parent feels a sense of high parenting competence. To demonstrate a minimum difference of 20 points on this questionnaire before and after the trial, with a standard deviation of 20, the number of participants required is 44
Two visits will be realized: a first in the month preceding the start of the trial (baseline) and a second in the month following the end of the trial.
Measured: baseline and month9
impact of trial of the attack July 14th on Cognitive alterations
Evaluation of cognitive alterations, in particular memory disorders and executive functions, will be aimed at children aged 0 to 6 at the time of the July 14, 2016 attack Episodic memory will be assessed using Grober and Buschke (Grober and Buschke, 1988). This test includes 16 items to memorize belonging to 16 different semantic categories. The duration of this test is approximately 20 minutes. This test starts with a control phase of the semantic encoding of words with an immediate cued recall, 3 free and cued recall phases with a 20-second interferential task, a recognition phase and finally a free and deferred cued recall phase to test learning.
Previous studies using this test show a mean difference of 2 points between the control groups and the experimental groups.
The evaluation of the cognitive alterations will include two stages: a first in the month preceding the start of the trial (baseline) and a second in the month following the end of the trial
Measured: baseline and month 6
impact of trial of the attack July 14th on schooling
Evaluation of the impact of schooling will focus on middle and high school students, using Pronote software and included in the arm "impacted by attack" .
In order to test the impact of the trial on children's education, several data will be requested from parents. Using the Pronote software, they will be able to communicate to us 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 to obtain the effective grades of children and adolescents. This data will be collected for the 2021-2022 school year (3 terms of the previous school year) and for the 2022-2023 school year (3 terms of the current year).
Measured: 2 years from baseline
impact of trial of the attack July 14th on Sleep disorders and associated somatizations
Evaluation of sleep disorders and associated somatizations will be offered to adolescents in the "14-7" cohort, are children aged 7 to 12 at the time of the attack.
The screening scale for sleep disorders in children aged 4 to 16 years by Bruni et al. 1996 . This questionnaire includes an overall sleep quality score, but also sub-indices evaluating insomnia, parasomnia, respiratory problems, non-restorative sleep and excessive daytime sleepiness. The threshold score is 39 and an average score around 25 for the control population.
This questionnaire will be carried out during the month preceding the opening of the trial (baseline), then every month, until the end of the trial.
From baseline to the end of trial, participants will receive a connected watches to continuously record sleep quality and daytime activity.
A questionnaire on Post Traumatic Stress Disorder (PTSD) symptoms will also be completed by the participants at baseline and at the end of trial.
Measured: baseline and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start21 Nov 2017
- Primary completionDec 2044 (estimated)
- Study completionDec 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional research involving the category 2 human person at minimal risk and constraint, excluding health product, multicentre
- Masking
- None (open label)
- Enrolment
- 728 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence ASKENAZY, MD, Principal investigator, Hôpitaux Pédiatriques de Nice CHU-LENVAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356028
- Sponsor's protocol ID
- 17-HPNCL-03
- Acronym
- Program14-7
- Status last verified
- Sep 2023
- First submitted
- 9 Nov 2017
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40986567Dumas 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.
PubMed 38954699Gindt 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.
PubMed 31572232
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pedopsychiatric and Multidisciplinary Research (Public Health, Psychodynamics, Neuroscience and Human and Social Sciences) Devoted to Children Exposed to the Attack in Nice on July 14, 2016
- ClinicalTrials.gov ID
- NCT03356028
- Acronym / sponsor ID
- Program14-7 / 17-HPNCL-03
- Conditions
- Psychiatric Disorder, Trauma, Psychological
- Keywords
- Trauma, Psychiatric Disorder, mass trauma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 728 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- Dec 2044 (estimated)
- Study completion
- Dec 2044 (estimated)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
On July 14, 2016, in Nice, children and their families were attacked by the organization "EI". This is the second time in our country that children are victims of this organization after the attack on the school Ozar Hotarah in March 2012 in Toulouse where four children were killed "touching end".
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). This pathology includes 4 main symptoms: the reviviscences of the event, avoidance behaviors, alterations of cognition and mood and neurovegetative overactivation. In addition, PTSD contributes to the development of many other mental disorders. It is estimated that 75% of adolescents or children having a comorbid disorder with PTSD. In the literature, the main comorbidities identified in pediatric populations are: anxiety disorders, Attention Deficit Hyperactivity Disorder (ADHD) and depression. There is no recommendation as to the therapeutics to be used in psychotraumatism in pediatric population. Epidemiological studies conducted on the consequences of trauma reveal a high variability in the development of psychopathologies. 6 to 20% of exposed children would develop PTSD after a potentially traumatic situation. Several factors can explain the heterogeneity of the results, including the age, the type of trauma experienced, the violence suffered during this trauma. In Nice, to date, more than 2200 children have consulted: 700 children between July 14 and July 28, 2016, 1100 children were seen between August and December, and about 400 since the creation of the Post Traumatic Pediatric Intersectoral Assessment Center (CE2P), in January 2017. 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.
Non-psychotic hallucinations represent a significant symptomatology in child psychiatry (1) and remain clinical question. The results of our previous study "the physalis child" showed a significant correlation between the persistence of non-psychotic acousto-verbal hallucinations (AVH) and the presence of negative emotions, linked to post traumatic stress disorder (PTSD). It seems important to understand the link between trauma and the presence of non-psychotic AVH in children as the literature shows the risk of progression to psychosis when these AVH persist.The interest of the ancllary study of "the physalis child" would be to prospectively observe the presence or not of non-psychotic AVH in the population with PTSD from the "Program 14-7". The question would then be: "Why in two subjects diagnosed with PTSD, one has non-psychotic HAV and the other does not?" 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.
The impending opening of the trial of the 14 July attack, the conduct and the media coverage associated with the trial are all factors that could be distressing for the children and families exposed to the attack in Nice. Re-exposure to testimonials and certain images can increase the risk of traumatic reactivation with a return of suppressed fears and the symptoms associated. Some factors have been identified as protective: social and family support, cognitive functioning, the presence of residual symptoms or the quality of sleep.
Therefore, an assessment of these factors before and after the opening of the trial would identify children and families with traumatic reactivation, as well as identify protective or risk factors for relapse of traumatic symptoms
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional research involving the category 2 human person at minimal risk and constraint, excluding health product, multicentre
| Arm | Type | Receives |
|---|---|---|
| impacted by the attack of 14 July 2016 | Other | Behavioral: Child and adolescent psychiatry and Epidemiology, Other: salivary biological collection, Behavioral: qualitative analysis of the discourse, Behavioral: Parenthood, Behavioral: Cognitive alterations, Behavioral: Impact on schooling, Behavioral: Sleep disorders and associated somatizationscharacterize 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 |
| control group | Other | Behavioral: Child and adolescent psychiatry and Epidemiologycharacterize the psycho-social factors of risk and / or protection interfering in the children's future with questionnaire of children controls |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (2 listed)
- a simple request from the child / adolescent and / or young adults or their parents (interruption of participation or withdrawal of consent);
- failure to comply with the instructions defined and exposed at the time of inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Child and adolescent psychiatry and Epidemiologypsychosocial risk assessment questionnaire, structured diagnostic interview, pedopsychiatric questionnaire | Behavioural | control group, impacted by the attack of 14 July 2016 |
| salivary biological collectionSaliva sampling will be done using a specific kit | Other | impacted by the attack of 14 July 2016 |
| qualitative analysis of the discoursetwo semi-structured interviews, the first with the teenager alone, the second with the lone parents | Behavioural | impacted by the attack of 14 July 2016 |
| ParenthoodParenting 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 | Behavioural | impacted by the attack of 14 July 2016 |
| Cognitive alterationsEpisodic 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 | Behavioural | impacted by the attack of 14 July 2016 |
| Impact on schoolingcollect 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 | Behavioural | impacted by the attack of 14 July 2016 |
| Sleep disorders and associated somatizationsEvaluation of sleep disorders and associated somatizations by connected watche and sleep questionnaire | Behavioural | impacted by the attack of 14 July 2016 |
Primary outcome
psychosocial risk assessment questionnaire after 2 year
Time frame: Difference between baseline and after 2 year
Completion of the psychosocial risk assessment questionnaire
30 secondary outcomes
psychosocial risk assessment questionnaire after 5 year
Time frame: Difference between baseline and after 5 year
psychosocial risk assessment questionnaire after 10 year
Time frame: Difference between baseline and after 10 year
psychosocial risk assessment questionnaire after 15 year
Time frame: Difference between baseline and after 15 year
psychosocial risk assessment questionnaire after 20 year
Time frame: Difference between baseline and after 20 year
psychosocial risk assessment questionnaire after 25 year
Time frame: Difference between baseline and after 25 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 2 year
Time frame: Difference between baseline and after 2 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 5 year
Time frame: Difference between baseline and after 5 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 10 year
Time frame: Difference between baseline and after 10 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 15 year
Time frame: Difference between baseline and after 15 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 20 year
Time frame: Difference between baseline and after 20 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 25 year
Time frame: Difference between baseline and after 25 year
Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 2 year
Time frame: Difference between baseline and after 2 year
Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 5 year
Time frame: Difference between baseline and after 5 year
Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 10 year
Time frame: Difference between baseline and after 10 year
Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 15 year
Time frame: Difference between baseline and after 15 year
Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 20 year
Time frame: Difference between baseline and after 20 year
Overall assessment of the individual CGI-S (Clinical Global Impression - Severity) after 25 year
Time frame: Difference between baseline and after 25 year
General operation CGA-S (Children's Global Assessment Scale) after 2 year
Time frame: Difference between baseline and after 2 year
General operation CGA-S (Children's Global Assessment Scale) after 5 year
Time frame: Difference between baseline and after 5 year
General operation CGA-S (Children's Global Assessment Scale) after 10 year
Time frame: Difference between baseline and after 10 year
General operation CGA-S (Children's Global Assessment Scale) after 15 year
Time frame: Difference between baseline and after 15 year
General operation CGA-S (Children's Global Assessment Scale) after 20 year
Time frame: Difference between baseline and after 20 year
General operation CGA-S (Children's Global Assessment Scale) after 25 year
Time frame: Difference between baseline and after 25 year
identify factors of social cognition linked to the presence of non-psychotic acousto-verbal hallucinations (AVH)
Time frame: at baseline
identify factors of emotional cognition linked to the presence of non-psychotic AVH
Time frame: at baseline
identify the factors of persistence of AVH
Time frame: after 6 months, 1 year and 2 year from baseline
impact of trial of the attack July 14th on Parenthood
Time frame: baseline and month9
impact of trial of the attack July 14th on Cognitive alterations
Time frame: baseline and month 6
impact of trial of the attack July 14th on schooling
Time frame: 2 years from baseline
impact of trial of the attack July 14th on Sleep disorders and associated somatizations
Time frame: baseline and month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Derived from this study: PubMed 40986567Dumas 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.
- Derived from this study: PubMed 38954699Dumas 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.
- Derived from this study: PubMed 31572232Gindt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence ASKENAZY, MD principal investigator
Hôpitaux Pédiatriques de Nice CHU-LENVAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child and adolescent psychiatry and Epidemiology, salivary biological collection and qualitative analysis of the discourse in people with Psychiatric Disorder and Trauma, Psychological, run by Fondation Lenval at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychosocial risk assessment questionnaire after 2 year (time frame: Difference between baseline and after 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03356028, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.