Child Cognitive-Affective Resilience Following 13-11 Event : A Pluridisciplinary Study of Intergenerational Transmission of a Traumatic Event (CARE 13-11)

Institut National de la Santé Et de la Recherche Médicale, France

Status: Enrolling

Conditions: Intergenerational Trauma

Treatments: Other: Cortisol sample; Other: MRI; Other: Psychological assessment; Behavioral: Cognitive assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT07203443

2022-A01409-34 (Other Identifier)

C21-80

Details and patient eligibility

About

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).

Enrollment: 960 estimated patients

Sex: All

Ages: 9+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

960 participants in 2 patient groups

Exposed group

Other group

Treatment:

Behavioral: Cognitive assessment

Other: Psychological assessment

Other: MRI

Other: Cortisol sample

Unexposed group

Other group

Treatment:

Behavioral: Cognitive assessment

Other: Psychological assessment

Other: MRI

Other: Cortisol sample