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

NCT07203443 | Recruiting DMC

• 2 other identifiers: C21-802022-A01409-34
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 1

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).

Conditions

Intergenerational Trauma

Keywords

Trauma; Offspring; Transmission; Psychology; Cognition; Physiology; Neuroimaging

Outcome Measures

Primary Outcomes (39)

• Assessment of Psychiatric nosography with MINI (parents)

  Psychological interview

  During the one day of assessments

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

  Results from CPSS-5 a semi-structered interview

  During the one day of assessments

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

  Results from SCID-5-CV which is a semi-structered interview for the diagnosis of mental disorders DSM-5

  During the one day of assessments

• Assessment of PTSD symptoms severity in adults

  Scores from PCL-5 which is a self report measure

  During the one day of assessments

• Secondary traumatisation

  Parents and children : Scores from FST

  During the one day of assessments

• Post-traumatic growth

  Parents : Scores from PTGI

  During the one day of assessments

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

  Scores from BCI

  During the one day of assessments

• Coping skills for parents and children 8-11 years

  Scores from SRCS.

  During the one day of assessments

• Resilience for parents and children over the age of 18

  Scores from ARM-R

  During the one day of assessments

• Resilience for children 8 to 11 years old

  Scores from CYRM-R-Child

  During the one day of assessments

• Resilience for children 12 to 17 years old

  Scores from CYRM-R-Youth

  During the one day of assessments

• Attachment

  Children : Scores from IPPA

  During the one day of assessments

• Anxiety

  Parents : scores from STAI

  During the one day of assessments

• Depression

  Parents : scores from BDI

  During the one day of assessments

• Self-esteem

  Parents : scores from SPP-Adult

  During the one day of assessments

• Emotion regulation for parents and children over the age of 18

  Scores from ERQ

  During the one day of assessments

• Emotion regulation for Children and adolescents aged 8 to 17

  Scores from ERQ-CA

  During the one day of assessments

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

  Scores from BES-A

  During the one day of assessments

• Empathy for Children 8-11 years

  Scores from BES-C

  During the one day of assessments

• World vision

  Parents and children : scores from WAS

  During the one day of assessments

• Well being

  Parents and children : score from WHO-5

  During the one day of assessments

• Assessment of Psychiatric nosography with CBCL/YSR (children)

  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

  During the one day of assessments

• Social support

  Parents : scores from Social Support Questionnaire

  During the one day of assessments

• Cognitive avoidance

  Parents and children : scores from QEC

  During the one day of assessments

• Bonding

  Parents and children : scores from PBI

  During the one day of assessments

• Familial functionning

  Parents and children :Scores from the FAD-SF

  During the one day of assessments

• Parenting style and practices

  Parents and children : Scores from the APQ

  During the one day of assessments

• Communication about 13-11 Event

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

  During the one day of assessments

• Attention

  Parents and children : scores from the Attentional Network Test

  During the one day of assessments

• Transmission of traumatic memory

  Parents and children : results from the Approach-Avoidance Task

  During the one day of assessments

• Executive functionning

  Children : scores from BRIEF

  During the one day of assessments

• Cortisol

  Parents and children : Cortisol Awakening Response

  During the morning of the one day of assessments

• Sleep - questionnaires for children 8-11 and 12-17 years

  Scores from SDSC

  During the one day of assessments

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

  Scores from PSQI

  During the one day of assessments

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

  Scores from ISI

  During the one day of assessments

• Sleep - actimetry Parents and children

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

  One week before the one day of assessments

• Sleep - planner Parents and children

  Evalustion of the sleep diary

  One week before the one day of assessments

• Neuroanatomical analysis

  Parents and children : anatomic MRI with the classic anatomical sequences

  During the one day of assessments

• Neurofunctional analysis

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

  During the one day of assessments

Study Arms (2)

Exposed group

OTHER

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

Unexposed group

OTHER

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

Interventions

MRI OTHER

Anatomical and functional MRI

Exposed group; Unexposed group

Psychological assessment OTHER

Inventories and clinical interviews

Exposed group; Unexposed group

Cognitive assessment BEHAVIORAL

Attention and memory tests

Exposed group; Unexposed group

Cortisol sample OTHER

Salivary test

Exposed group; Unexposed group

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)
• Parent's refusal to participate in research
• For parents carrying out the protocol on site:

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Umr-S 1077 Nimh

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Historical Trauma; Wounds and Injuries

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Psychological Trauma; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Bérengère Guillery

  Université de Caen Normandie, Inserm, EPHE-PSL, PSL University, CHU de Caen, GIP Cyceron, U1077, NIMH, 14000 Caen, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: October 2, 2025
• Study Start: December 17, 2024
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)