Intergenerational TraumaCARE 13-11NCT07203443

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

A study testing MRI, Psychological assessment and Cognitive assessment in people with Intergenerational Trauma, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 9 years and olderHealthy volunteers can take part
Conditions the study is for: Intergenerational Trauma
What is being tested?: MRI, Psychological assessment and Cognitive assessment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 960 participants
Where: 1 siteFrance
Study dates: 17 Dec 2024to 30 Sep 2028
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Show all 51Show fewer

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

Who cannot join

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

Show all 21Show fewer

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting

Umr-S 1077 Nimh
Caen, 14000
Fabian Guénolé, +33231272309, guenole-f@chu-caen.fr
Recruiting

Other trials in France

About this study

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
Being tested: MRI, Psychological assessment, Cognitive assessment, Cortisol sample
Keywords: Trauma, Offspring, Transmission, Psychology, Cognition, Physiology, Neuroimaging
Medical subject headings: Historical Trauma, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MRIOther
Anatomical and functional MRI
Psychological assessmentOther
Inventories and clinical interviews
Cognitive assessmentBehavioural
Attention and memory tests
Cortisol sampleOther
Salivary test

Study groups in NCT07203443
Study group	Role	What they receive
Exposed group	Other	Not described Receives: Other: MRI; Other: Psychological assessment; Behavioral: Cognitive assessment; Other: Cortisol sample
Unexposed group	Other	Not described Receives: Other: MRI; Other: Psychological assessment; Behavioral: Cognitive assessment; Other: Cortisol sample

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of Psychiatric nosography with MINI (parents)
Psychological interview
Measured: 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
Measured: 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
Measured: During the one day of assessments
Assessment of PTSD symptoms severity in adults
Scores from PCL-5 which is a self report measure
Measured: During the one day of assessments
Secondary traumatisation
Parents and children : Scores from FST
Measured: During the one day of assessments
Post-traumatic growth
Parents : Scores from PTGI
Measured: During the one day of assessments
Coping skills for parents, children 12-17 years and over the age of 18
Scores from BCI
Measured: During the one day of assessments
Coping skills for parents and children 8-11 years
Scores from SRCS.
Measured: During the one day of assessments
Resilience for parents and children over the age of 18
Scores from ARM-R
Measured: During the one day of assessments
Resilience for children 8 to 11 years old
Scores from CYRM-R-Child
Measured: During the one day of assessments
Resilience for children 12 to 17 years old
Scores from CYRM-R-Youth
Measured: During the one day of assessments
Attachment
Children : Scores from IPPA
Measured: During the one day of assessments
Anxiety
Parents : scores from STAI
Measured: During the one day of assessments
Depression
Parents : scores from BDI
Measured: During the one day of assessments
Self-esteem
Parents : scores from SPP-Adult
Measured: During the one day of assessments
Emotion regulation for parents and children over the age of 18
Scores from ERQ
Measured: During the one day of assessments
Emotion regulation for Children and adolescents aged 8 to 17
Scores from ERQ-CA
Measured: During the one day of assessments
Empathy for Parents, chidren 12-17 years and children over the age of 18
Scores from BES-A
Measured: During the one day of assessments
Empathy for Children 8-11 years
Scores from BES-C
Measured: During the one day of assessments
World vision
Parents and children : scores from WAS
Measured: During the one day of assessments
Well being
Parents and children : score from WHO-5
Measured: 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
Measured: During the one day of assessments
Social support
Parents : scores from Social Support Questionnaire
Measured: During the one day of assessments
Cognitive avoidance
Parents and children : scores from QEC
Measured: During the one day of assessments
Bonding
Parents and children : scores from PBI
Measured: During the one day of assessments
Familial functionning
Parents and children :Scores from the FAD-SF
Measured: During the one day of assessments
Parenting style and practices
Parents and children : Scores from the APQ
Measured: During the one day of assessments
Communication about 13-11 Event
Parents and children : results from Communication about 13-11 Event Interview
Measured: During the one day of assessments
Attention
Parents and children : scores from the Attentional Network Test
Measured: During the one day of assessments
Transmission of traumatic memory
Parents and children : results from the Approach-Avoidance Task
Measured: During the one day of assessments
Executive functionning
Children : scores from BRIEF
Measured: During the one day of assessments
Cortisol
Parents and children : Cortisol Awakening Response
Measured: During the morning of the one day of assessments
Sleep - questionnaires for children 8-11 and 12-17 years
Scores from SDSC
Measured: During the one day of assessments
Sleep - questionnaires for Parents and children over the age of 18
Scores from PSQI
Measured: During the one day of assessments
Sleep - questionnaires for Parents and children over the age of 18
Scores from ISI
Measured: 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).
Measured: One week before the one day of assessments
Sleep - planner Parents and children
Evalustion of the sleep diary
Measured: One week before the one day of assessments
Neuroanatomical analysis
Parents and children : anatomic MRI with the classic anatomical sequences
Measured: During the one day of assessments
Neurofunctional analysis
Parents and children fonctionnal MRI with the measurement of the magnitude of the BOLD signal
Measured: During the one day of assessments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 202430 Sep 2028

First posted2 Oct 2025
Study start17 Dec 2024
Primary completion30 Sep 2028 (estimated)
Study completion30 Sep 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intergenerational TraumaStudies of the same condition, open and under way.
More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 960 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07203443
Sponsor's protocol ID: C21-80
Other IDs: 2022-A01409-34
Acronym: CARE 13-11
Status last verified: Oct 2026
First submitted: 20 Feb 2025
Last updated: 19 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No