NCT07203443 Child Cognitive-Affective Resilience Following 13-11 Event : A Pluridisciplinary Study of Intergenerational Transmission of a Traumatic Event
| NCT ID | NCT07203443 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | Intergenerational Trauma |
| Study Type | INTERVENTIONAL |
| Enrollment | 960 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 960 participants in total. It began in 2024-12-17 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 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 * Minor child born before November 13, 2015 * Whose aunt or uncle was directly exposed to the attacks * Child with a good command of the French language * Who has given written consent * Whose parents with parental authority have given written consent for their child's their child's participation * Whose parent is affiliated to a social security scheme or is a beneficiary of such a scheme Unexposed group Child * Minor child born before November 13, 2015 * No relative (family or close friend) has been exposed to the attacks * With a good command of the French language * Whose parents have given their written consent for their child's their child's participation * One of whose parents is affiliated to or benefits from a social security scheme Parent 1 * Parent of child(ren) included * No exposure to the attacks and no close relative (family or close friend) exposed to the attacks attacks * No PTSD at the time of inclusion (PCL-5 \< 33) * Have a good command of the French language * Affiliated with or benefiting from a social security scheme * Having given written consent Parent 2 * Parent of included child(ren) * No exposure to terrorist attacks * With a good command of the French language * Affiliated with or benefiting from a social security scheme * Having given written consent Exclusion Criteria: 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
Contact & Investigator
Bérengère Guillery
STUDY DIRECTOR
Université de Caen Normandie, Inserm, EPHE-PSL, PSL University, CHU de Caen, GIP Cyceron, U1077, NIMH, 14000 Caen, France
Frequently Asked Questions
Who can join the NCT07203443 clinical trial?
This trial is open to participants of all sexes, aged 9 Years or older, studying Intergenerational Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07203443 currently recruiting?
Yes, NCT07203443 is actively recruiting participants. Visit ClinicalTrials.gov or contact Institut National de la Santé Et de la Recherche Médicale, France to inquire about joining.
Where is the NCT07203443 trial being conducted?
This trial is being conducted at Caen, France.
Who is sponsoring the NCT07203443 clinical trial?
NCT07203443 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The principal investigator is Bérengère Guillery at Université de Caen Normandie, Inserm, EPHE-PSL, PSL University, CHU de Caen, GIP Cyceron, U1077, NIMH, 14000 Caen, France. The trial plans to enroll 960 participants.