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NCT Number: NCT07203443

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

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).

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Key information

Conditions

Intergenerational Trauma Historical Trauma Mental Disorders Psychological Trauma Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

Anatomical and functional MRI

psychological assessment

Other

Inventories and clinical interviews

Cognitive assessment

Behavioral

Attention and memory tests

Cortisol sample

Other

Salivary test

Primary outcomes

  1. Assessment of Psychiatric nosography with MINI (parents)

    Time frame: During the one day of assessments

    Psychological interview

  2. Assessment of PTSD symptoms severity in children 8-11 years and 12-17 years

    Time frame: During the one day of assessments

    Results from CPSS-5 a semi-structered interview

  3. Assesssment of PTSD symptoms for parents and children over the age of 18

    Time frame: 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

  4. Assessment of PTSD symptoms severity in adults

    Time frame: During the one day of assessments

    Scores from PCL-5 which is a self report measure

  5. Secondary traumatisation

    Time frame: During the one day of assessments

    Parents and children : Scores from FST

  6. Post-traumatic growth

    Time frame: During the one day of assessments

    Parents : Scores from PTGI

  7. Coping skills for parents, children 12-17 years and over the age of 18

    Time frame: During the one day of assessments

    Scores from BCI

  8. Coping skills for parents and children 8-11 years

    Time frame: During the one day of assessments

    Scores from SRCS.

  9. Resilience for parents and children over the age of 18

    Time frame: During the one day of assessments

    Scores from ARM-R

  10. Resilience for children 8 to 11 years old

    Time frame: During the one day of assessments

    Scores from CYRM-R-Child

  11. Resilience for children 12 to 17 years old

    Time frame: During the one day of assessments

    Scores from CYRM-R-Youth

  12. Attachment

    Time frame: During the one day of assessments

    Children : Scores from IPPA

  13. Anxiety

    Time frame: During the one day of assessments

    Parents : scores from STAI

  14. Depression

    Time frame: During the one day of assessments

    Parents : scores from BDI

  15. Self-esteem

    Time frame: During the one day of assessments

    Parents : scores from SPP-Adult

  16. Emotion regulation for parents and children over the age of 18

    Time frame: During the one day of assessments

    Scores from ERQ

  17. Emotion regulation for Children and adolescents aged 8 to 17

    Time frame: During the one day of assessments

    Scores from ERQ-CA

  18. Empathy for Parents, chidren 12-17 years and children over the age of 18

    Time frame: During the one day of assessments

    Scores from BES-A

  19. Empathy for Children 8-11 years

    Time frame: During the one day of assessments

    Scores from BES-C

  20. World vision

    Time frame: During the one day of assessments

    Parents and children : scores from WAS

  21. Well being

    Time frame: During the one day of assessments

    Parents and children : score from WHO-5

  22. Assessment of Psychiatric nosography with CBCL/YSR (children)

    Time frame: 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

  23. Social support

    Time frame: During the one day of assessments

    Parents : scores from Social Support Questionnaire

  24. Cognitive avoidance

    Time frame: During the one day of assessments

    Parents and children : scores from QEC

  25. Bonding

    Time frame: During the one day of assessments

    Parents and children : scores from PBI

  26. Familial functionning

    Time frame: During the one day of assessments

    Parents and children :Scores from the FAD-SF

  27. Parenting style and practices

    Time frame: During the one day of assessments

    Parents and children : Scores from the APQ

  28. Communication about 13-11 Event

    Time frame: During the one day of assessments

    Parents and children : results from Communication about 13-11 Event Interview

  29. Attention

    Time frame: During the one day of assessments

    Parents and children : scores from the Attentional Network Test

  30. Transmission of traumatic memory

    Time frame: During the one day of assessments

    Parents and children : results from the Approach-Avoidance Task

  31. Executive functionning

    Time frame: During the one day of assessments

    Children : scores from BRIEF

  32. Cortisol

    Time frame: During the morning of the one day of assessments

    Parents and children : Cortisol Awakening Response

  33. Sleep - questionnaires for children 8-11 and 12-17 years

    Time frame: During the one day of assessments

    Scores from SDSC

  34. Sleep - questionnaires for Parents and children over the age of 18

    Time frame: During the one day of assessments

    Scores from PSQI

  35. Sleep - questionnaires for Parents and children over the age of 18

    Time frame: During the one day of assessments

    Scores from ISI

  36. Sleep - actimetry Parents and children

    Time frame: One week before the one day of assessments

    Measurement of bedtimes and wake-up times using an actimeter (a wrist-worn watch-size device).

  37. Sleep - planner Parents and children

    Time frame: One week before the one day of assessments

    Evalustion of the sleep diary

  38. Neuroanatomical analysis

    Time frame: During the one day of assessments

    Parents and children : anatomic MRI with the classic anatomical sequences

  39. Neurofunctional analysis

    Time frame: During the one day of assessments

    Parents and children fonctionnal MRI with the measurement of the magnitude of the BOLD signal

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Acronym: CARE 13-11

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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