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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07203443
Acronym
CARE 13-11
Enrollment
960
Registered
2025-10-02
Start date
2024-12-17
Completion date
2027-01-15
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intergenerational Trauma

Keywords

Trauma, Offspring, Transmission, Psychology, Cognition, Physiology, Neuroimaging

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).

Interventions

OTHERMRI

Anatomical and functional MRI

Inventories and clinical interviews

BEHAVIORALCognitive assessment

Attention and memory tests

OTHERCortisol sample

Salivary test

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep - planner Parents and childrenOne week before the one day of assessmentsEvalustion of the sleep diary
Neuroanatomical analysisDuring the one day of assessmentsParents and children : anatomic MRI with the classic anatomical sequences
Sleep - actimetry Parents and childrenOne week before the one day of assessmentsMeasurement of bedtimes and wake-up times using an actimeter (a wrist-worn watch-size device).
Transmission of traumatic memoryDuring the one day of assessmentsParents and children : results from the Approach-Avoidance Task
Executive functionningDuring the one day of assessmentsChildren : scores from BRIEF
CortisolDuring the morning of the one day of assessmentsParents and children : Cortisol Awakening Response
Sleep - questionnaires for children 8-11 and 12-17 yearsDuring the one day of assessmentsScores from SDSC
Sleep - questionnaires for Parents and children over the age of 18During the one day of assessmentsScores from PSQI
Assessment of Psychiatric nosography with MINI (parents)During the one day of assessmentsPsychological interview
Assessment of PTSD symptoms severity in children 8-11 years and 12-17 yearsDuring the one day of assessmentsResults from CPSS-5 a semi-structered interview
Assesssment of PTSD symptoms for parents and children over the age of 18During the one day of assessmentsResults from SCID-5-CV which is a semi-structered interview for the diagnosis of mental disorders DSM-5
Assessment of PTSD symptoms severity in adultsDuring the one day of assessmentsScores from PCL-5 which is a self report measure
Secondary traumatisationDuring the one day of assessmentsParents and children : Scores from FST
Post-traumatic growthDuring the one day of assessmentsParents : Scores from PTGI
Coping skills for parents, children 12-17 years and over the age of 18During the one day of assessmentsScores from BCI
Coping skills for parents and children 8-11 yearsDuring the one day of assessmentsScores from SRCS.
Resilience for parents and children over the age of 18During the one day of assessmentsScores from ARM-R
Resilience for children 8 to 11 years oldDuring the one day of assessmentsScores from CYRM-R-Child
Resilience for children 12 to 17 years oldDuring the one day of assessmentsScores from CYRM-R-Youth
AttachmentDuring the one day of assessmentsChildren : Scores from IPPA
AnxietyDuring the one day of assessmentsParents : scores from STAI
DepressionDuring the one day of assessmentsParents : scores from BDI
Self-esteemDuring the one day of assessmentsParents : scores from SPP-Adult
Emotion regulation for parents and children over the age of 18During the one day of assessmentsScores from ERQ
Emotion regulation for Children and adolescents aged 8 to 17During the one day of assessmentsScores from ERQ-CA
Empathy for Parents, chidren 12-17 years and children over the age of 18During the one day of assessmentsScores from BES-A
Empathy for Children 8-11 yearsDuring the one day of assessmentsScores from BES-C
World visionDuring the one day of assessmentsParents and children : scores from WAS
Well beingDuring the one day of assessmentsParents and children : score from WHO-5
Assessment of Psychiatric nosography with CBCL/YSR (children)During the one day of assessmentsTotal 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 supportDuring the one day of assessmentsParents : scores from Social Support Questionnaire
Cognitive avoidanceDuring the one day of assessmentsParents and children : scores from QEC
BondingDuring the one day of assessmentsParents and children : scores from PBI
Familial functionningDuring the one day of assessmentsParents and children :Scores from the FAD-SF
Parenting style and practicesDuring the one day of assessmentsParents and children : Scores from the APQ
Communication about 13-11 EventDuring the one day of assessmentsParents and children : results from Communication about 13-11 Event Interview
AttentionDuring the one day of assessmentsParents and children : scores from the Attentional Network Test
Neurofunctional analysisDuring the one day of assessmentsParents and children fonctionnal MRI with the measurement of the magnitude of the BOLD signal

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026