Child Cognitive-Affective Resilience Following 13-11 Event : A Pluridisciplinary Study of Intergenerational Transmission of a Traumatic Event
Recruiting now · Not applicable
Conditions studied: Intergenerational Trauma
In brief
CARE 13-11 study explores the transmission of trauma within families. Exposure to a traumatic event can have an impact on those directly exposed, but also on their family. This transmission is both biological and behavioral, leading to adaptation that is still poorly understood. CARE 13-11 project offers a unique opportunity to bring together different disciplinary fields, from neuroscience to human and social sciences, to understand this phenomenon. To answer these questions, the study includes directly exposed families with minor children born before the events, as well as families with no exposure to these events (the so-called "control" group).
Key facts
- Study ID
- NCT07203443
- Run by
- Institut National de la Santé Et de la Recherche Médicale, France
- People needed
- 960
- Starts
- 2024-12-17
- Expected to finish
- 2027-01-15
- Last updated by the study team
- 2025-10-02
Who can join
Age: 9 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Exposed group
- Children
- Minor child born before November 13, 2015
- At least one parent was present at the scene of the attacks: criteria A1 (directly exposed to the event) or exposed to the event) or A2 (witnessed the event) of DSM-5
- With a good command of the French language (francophone)
- Whose parents have given written consent for their child's their child's participation
- At least one parent is covered by health insurance
- Parent 1 (and Parent 3)
- Parent of child(ren) included
- Directly exposed to the attacks: present at the scene of the attacks: criteria A1 (directly exposed to the event) or to the event) or A2 (witness to the event) of the DSM-5
- Good command of the French language
- Affiliated with or benefiting from a social security scheme
- Has given written consent
- Parent 2
- Parent of child(ren) included
- Not exposed but whose spouse (or ex-spouse) was directly exposed to the attacks on a declarative basis
- Have a good command of the French language
- Affiliated with a social security scheme or beneficiary of such a scheme
- Having given written consent
- Uncle/aunt
- Not exposed, but has a brother or sister directly exposed to the attacks
- Have a good command of the French language
- Beneficiary of health insurance
- Having given written consent
- Cousin
You may not qualify if…
- For all children:
- Loss of both parents following the events of November 13
- Presence of a history of severe neurological, mental or psychopathological disorders (epilepsy, head trauma with loss of consciousness of more than one hour, autism spectrum disorder, intellectual disability, schizophrenia)
- Persons subject to a legal protection measure (safeguard of justice, curatorship, guardianship)
- Subject to a period of exclusion in the context of another research project
- Refusal of the child to participate in research
- For children undergoing the on-site protocol:
- Person with contraindications to MRI
- For women of childbearing age, pregnancy in progress
- Psychotropic products capable of modifying attention, vigilance and concentration taken less than 24 hours before questionnaires or examinations (sleeping pills and hypnotics, antipsychotics, mood regulators, antiepileptics and antihistamines). If in doubt about the patient's ability the patient's ability to postpone treatment, advice should be sought from the attending physician.
- in the case of antipsychotics and antiepileptics
- For all parents:
- Presence of a history of neurological or neurodevelopmental disorders prior to the attacks except ADHD (epilepsy, head trauma with loss of consciousness of more than one hour, autism spectrum disorder autism spectrum disorder, intellectual disability, schizophrenia)
- Persons subject to a legal protection measure (safeguard of justice, curatorship, guardianship)
- Subject to a period of exclusion in the context of another research project
- Parent's refusal to participate in research
- For parents carrying out the protocol on site:
- Person with contraindications to MRI
- For women of childbearing age, current or planned pregnancy
- Psychotropic products capable of modifying attention, vigilance and concentration taken less than 24 hours before questionnaires or examinations (sleeping pills and hypnotics, antipsychotics, mood regulators, antiepileptics and antihistamines). If in doubt about the patient's ability the patient's ability to postpone treatment, advice should be sought from the attending physician.
- in the case of antipsychotics and antiepileptics
Where it is running
- Umr-S 1077 Nimh — Caen, France (enrolling)
Full record on ClinicalTrials.gov
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