Clinical Trials in France / NCT07203443
Recruiting
Not applicable
Child Cognitive-Affective Resilience Following 13-11 Event : A Pluridisciplinary Study of Intergenerational Transmission of a Traumatic Event
NCT07203443 · tracked via the Priya Life Science France tracker
Condition(s) studied
Intergenerational Trauma
Investigational drug(s) / intervention(s)
MRIPsychological assessmentCognitive assessmentCortisol sample
MRI: Anatomical and functional MRI
Psychological assessment: Inventories and clinical interviews
Cognitive assessment: Attention and memory tests
Cortisol sample: Salivary test
Study 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
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
Primary outcome measure(s)
- Assessment of Psychiatric nosography with MINI (parents) — During the one day of assessments
Psychological interview - Assessment of PTSD symptoms severity in children 8-11 years and 12-17 years — During the one day of assessments
Results from CPSS-5 a semi-structered interview - Assesssment of PTSD symptoms for parents and children over the age of 18 — During the one day of assessments
Results from SCID-5-CV which is a semi-structered interview for the diagnosis of mental disorders DSM-5 - Assessment of PTSD symptoms severity in adults — During the one day of assessments
Scores from PCL-5 which is a self report measure - Secondary traumatisation — During the one day of assessments
Parents and children : Scores from FST - Post-traumatic growth — During the one day of assessments
Parents : Scores from PTGI - Coping skills for parents, children 12-17 years and over the age of 18 — During the one day of assessments
Scores from BCI - Coping skills for parents and children 8-11 years — During the one day of assessments
Scores from SRCS. - Resilience for parents and children over the age of 18 — During the one day of assessments
Scores from ARM-R - Resilience for children 8 to 11 years old — During the one day of assessments
Scores from CYRM-R-Child - Resilience for children 12 to 17 years old — During the one day of assessments
Scores from CYRM-R-Youth - Attachment — During the one day of assessments
Children : Scores from IPPA - Anxiety — During the one day of assessments
Parents : scores from STAI - Depression — During the one day of assessments
Parents : scores from BDI - Self-esteem — During the one day of assessments
Parents : scores from SPP-Adult - Emotion regulation for parents and children over the age of 18 — During the one day of assessments
Scores from ERQ - Emotion regulation for Children and adolescents aged 8 to 17 — During the one day of assessments
Scores from ERQ-CA - Empathy for Parents, chidren 12-17 years and children over the age of 18 — During the one day of assessments
Scores from BES-A - Empathy for Children 8-11 years — During the one day of assessments
Scores from BES-C - World vision — During the one day of assessments
Parents and children : scores from WAS - Well being — During the one day of assessments
Parents and children : score from WHO-5 - Assessment of Psychiatric nosography with CBCL/YSR (children) — During the one day of assessments
Total score, Main scales: Internalized behaviours, Externalized behaviours, Subscales: Anxiety/Depression, Social withdrawal, Somatic complaints, Interpersonal problems, Thought disorder, Attention deficit disorder, Deviant behaviours, Aggressive behaviours, Other problems - Social support — During the one day of assessments
Parents : scores from Social Support Questionnaire - Cognitive avoidance — During the one day of assessments
Parents and children : scores from QEC - Bonding — During the one day of assessments
Parents and children : scores from PBI - Familial functionning — During the one day of assessments
Parents and children :Scores from the FAD-SF - Parenting style and practices — During the one day of assessments
Parents and children : Scores from the APQ - Communication about 13-11 Event — During the one day of assessments
Parents and children : results from Communication about 13-11 Event Interview - Attention — During the one day of assessments
Parents and children : scores from the Attentional Network Test - Transmission of traumatic memory — During the one day of assessments
Parents and children : results from the Approach-Avoidance Task - Executive functionning — During the one day of assessments
Children : scores from BRIEF - Cortisol — During the morning of the one day of assessments
Parents and children : Cortisol Awakening Response - Sleep - questionnaires for children 8-11 and 12-17 years — During the one day of assessments
Scores from SDSC - Sleep - questionnaires for Parents and children over the age of 18 — During the one day of assessments
Scores from PSQI - Sleep - questionnaires for Parents and children over the age of 18 — During the one day of assessments
Scores from ISI - Sleep - actimetry Parents and children — One week before the one day of assessments
Measurement of bedtimes and wake-up times using an actimeter (a wrist-worn watch-size device). - Sleep - planner Parents and children — One week before the one day of assessments
Evalustion of the sleep diary - Neuroanatomical analysis — During the one day of assessments
Parents and children : anatomic MRI with the classic anatomical sequences - Neurofunctional analysis — During the one day of assessments
Parents and children fonctionnal MRI with the measurement of the magnitude of the BOLD signal
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Umr-S 1077 Nimh | Caen | France | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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