Status:
RECRUITING
Child Cognitive-Affective Resilience Following 13-11 Event : A Pluridisciplinary Study of Intergenerational Transmission of a Traumatic Event
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Intergenerational Trauma
Eligibility:
All Genders
9+ years
Phase:
NA
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2027
Estimated Enrollment :
960 Patients enrolled
Trial Details
Trial ID
NCT07203443
Start Date
December 17 2024
End Date
January 15 2027
Last Update
October 2 2025
Active Locations (1)
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1
Umr-S 1077 Nimh
Caen, France, 14000