An interventional study of Child and adolescent psychiatry and Epidemiology and salivary biological collection in Psychiatric Disorder and Trauma, Psychological, sponsored by Fondation Lenval. Active, not recruiting at 1 site in France. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Fondation Lenval · Not applicable, Interventional, and Diagnostic
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Among 12 studies in Psychological Trauma with a site in France — 5 open to participants now, 6 under way, none of them phase 3. Psychological Trauma · France.
Among the 12 studies in Psychological Trauma with a site in France, this one is one of 2 that started in 2017, is one of 7 with no phase, and was the 1st registered.
140 studies on the registry are indexed under Psychological Trauma; 43 are open to participants now.
Browse Psychological Trauma studies →5 of the 12 studies in Psychological Trauma with a site in France are open now. Recruiting first, the newest first:
Hôpital le Vinatier · Sites in France
Ages 18–30 · Healthy volunteers
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
Fondation Lenval · Sites in France
Ages 3–6
Alliance Equiphoria · Sites in France
Ages 18+
Dominique JANUEL · Sites in France
Ages 18–70 · Women only
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 28 Psychological Trauma studies recruiting now, 12 (43%) set no upper age limit and 14 (50%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: Up to 18 Years · all sexes · healthy volunteers too.
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12 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 2 started in 2017.
This study's enrollment of 728 is above the median of 80 across 108 interventional studies indexed under Psychological Trauma.
Median enrollment 60 across the 7 interventional studies, 116 across the 5 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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None of the 12 has an industry lead sponsor. The 10 most frequent:
Fondation Lenval is the lead sponsor of 61 studies on the registry; 18 are open to participants now.
Fondation Lenval has 3 studies filed under Psychological Trauma — fewer than ten, so there is no comparison to draw.
1 of the studies in Psychological Trauma with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06289348Assistance Publique - Hôpitaux de ParisAnnouncement of Rare Metabolic Diseases in Systematic Newborn Screening: the Phenylketonuria Experience. | 2027-05-01 |
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Among the 12 studies in Psychological Trauma with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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
140 studies on the registry are indexed under Psychological Trauma; 43 are open to participants now.
This study's enrollment of 728 is above the median of 80 across 108 interventional studies indexed under Psychological Trauma.
Browse Psychological Trauma studies →Fondation Lenval is the lead sponsor of 61 studies on the registry; 18 are open to participants now.
Compared within Psychological Trauma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mental Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non inclusion:
Exclusion Criteria:
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 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
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
psychosocial risk assessment questionnaire, structured diagnostic interview, pedopsychiatric questionnaire
Saliva sampling will be done using a specific kit
two semi-structured interviews, the first with the teenager alone, the second with the lone parents
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
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
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
Evaluation of sleep disorders and associated somatizations by connected watche and sleep questionnaire
psychosocial risk assessment questionnaire after 2 year
Completion of the psychosocial risk assessment questionnaire
Time frame: Difference between baseline and after 2 year
psychosocial risk assessment questionnaire after 5 year
Completion of the psychosocial risk assessment questionnaire
Time frame: Difference between baseline and after 5 year
psychosocial risk assessment questionnaire after 10 year
Completion of the psychosocial risk assessment questionnaire
Time frame: Difference between baseline and after 10 year
psychosocial risk assessment questionnaire after 15 year
Completion of the psychosocial risk assessment questionnaire
Time frame: Difference between baseline and after 15 year
psychosocial risk assessment questionnaire after 20 year
Completion of the psychosocial risk assessment questionnaire
Time frame: Difference between baseline and after 20 year
psychosocial risk assessment questionnaire after 25 year
Completion of the psychosocial risk assessment questionnaire
Time frame: Difference between baseline and after 25 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 2 year
Completion of the MINI questionnaire
Time frame: Difference between baseline and after 2 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 5 year
Completion of the MINI questionnaire
Time frame: Difference between baseline and after 5 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 10 year
Completion of the MINI questionnaire
Time frame: Difference between baseline and after 10 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 15 year
Completion of the MINI questionnaire
Time frame: Difference between baseline and after 15 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 20 year
Completion of the MINI questionnaire
Time frame: Difference between baseline and after 20 year
Structured diagnostic interview MINI (Mini International Neuropsychiatric Interview) after 25 year
Completion of the MINI questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Difference between baseline and after 25 year
General operation CGA-S (Children's Global Assessment Scale) after 2 year
Completion of the CGA-S
Time frame: Difference between baseline and after 2 year
General operation CGA-S (Children's Global Assessment Scale) after 5 year
Completion of the CGA-S
Time frame: Difference between baseline and after 5 year
General operation CGA-S (Children's Global Assessment Scale) after 10 year
Completion of the CGA-S
Time frame: Difference between baseline and after 10 year
General operation CGA-S (Children's Global Assessment Scale) after 15 year
Completion of the CGA-S
Time frame: Difference between baseline and after 15 year
General operation CGA-S (Children's Global Assessment Scale) after 20 year
Completion of the CGA-S
Time frame: Difference between baseline and after 20 year
General operation CGA-S (Children's Global Assessment Scale) after 25 year
Completion of the CGA-S
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)
completion of the NEPSY II for a complete neuropsychological assessment
Time frame: 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
Time frame: at baseline
identify the factors of persistence of AVH
complete neuropsychological assessment
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: baseline and month 6
Plan to share: No
Started Nov 2017 (actual). Primary completion is estimated for Dec 2044, 325 months after the start.
Of 82 non-industry interventional studies with no phase under Psychological Trauma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 325 months is above that.
Counting every sponsor, half of 83 studies reached it within 24 months; a quarter within 12 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Fondation Lenval