Child cognitive and emotional resilience after the November 13 attacks and intergenerational effects of trauma
Child Cognitive-Affective Resilience Following 13-11 Event : A Pluridisciplinary Study of Intergenerational Transmission of a Traumatic Event
This project tests whether parents' exposure to the November 13, 2015 attacks affects their children's thinking, emotions, brain function, and stress hormones using brain scans, psychological and cognitive tests, and saliva samples.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 960 (estimated) |
| Ages | 9 Years and up |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 1 site (Caen) |
| Trial ID | NCT07203443 on ClinicalTrials.gov |
What this trial studies
CARE 13-11 brings together neuroscience and human and social sciences to explore how trauma experienced by parents during the November 13, 2015 attacks may be passed on to their children. The project enrolls families where at least one parent was directly exposed to the attacks and has a minor child born before November 13, 2015, alongside control families with no exposure. Participants complete MRI scans, standardized psychological and cognitive assessments, and cortisol sampling to capture brain, behavioral, and hormonal measures. Comparisons between exposed and unexposed families aim to separate biological from social pathways of intergenerational trauma transmission.
Who should consider this trial
Good fit: Francophone families in which at least one parent was present at the November 13, 2015 attacks and who have a minor child born before November 13, 2015, parental consent, and health insurance are the intended participants.
Not a fit: Families without exposure to the November 13 attacks, non-francophone households, children born after November 13, 2015, or anyone unable to undergo MRI or provide biological samples are unlikely to receive direct benefit.
Why it matters
Potential benefit: If successful, the project could reveal brain, behavioral, or hormonal markers that help target prevention and support for children at risk from parental trauma.
How similar studies have performed: Other research has reported behavioral and biological signs of intergenerational trauma in different populations, but combining MRI, cognitive testing, and cortisol sampling in this specific post-attack cohort is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Caen
- Umr-S 1077 Nimh — Caen, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.