--- title: "Child Cognitive-Affective Resilience Following 13-11 Event : A Pluridisciplinary Study of Intergenerational Transmission of a Traumatic Event" nct_id: NCT07203443 overall_status: RECRUITING phase: NA sponsor: Institut National de la Santé Et de la Recherche Médicale, France study_type: INTERVENTIONAL primary_condition: Intergenerational Trauma countries: France canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07203443.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07203443" ct_last_update_post_date: 2025-10-02 last_seen_at: "2026-05-12T07:34:26.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Child Cognitive-Affective Resilience Following 13-11 Event : A Pluridisciplinary Study of Intergenerational Transmission of a Traumatic Event **NCT ID:** [NCT07203443](https://clinicaltrials.gov/study/NCT07203443) ## Key Facts - **Status:** RECRUITING - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 960 - **Lead Sponsor:** Institut National de la Santé Et de la Recherche Médicale, France - **Conditions:** Intergenerational Trauma - **Start Date:** 2024-12-17 - **Completion Date:** 2027-01-15 - **CT.gov Last Update:** 2025-10-02 ## 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). ## Eligibility - **Minimum age:** 9 Years - **Sex:** ALL - **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 ``` ## Arms - **Exposed group** (OTHER) - **Unexposed group** (OTHER) ## Interventions - **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 - **Assessment of Psychiatric nosography with MINI (parents)** _(time frame: During the one day of assessments)_ — Psychological interview - **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 - **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 - **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 - **Secondary traumatisation** _(time frame: During the one day of assessments)_ — Parents and children : Scores from FST - **Post-traumatic growth** _(time frame: During the one day of assessments)_ — Parents : Scores from PTGI - **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 - **Coping skills for parents and children 8-11 years** _(time frame: During the one day of assessments)_ — Scores from SRCS. - **Resilience for parents and children over the age of 18** _(time frame: During the one day of assessments)_ — Scores from ARM-R - **Resilience for children 8 to 11 years old** _(time frame: During the one day of assessments)_ — Scores from CYRM-R-Child - **Resilience for children 12 to 17 years old** _(time frame: During the one day of assessments)_ — Scores from CYRM-R-Youth - **Attachment** _(time frame: During the one day of assessments)_ — Children : Scores from IPPA - **Anxiety** _(time frame: During the one day of assessments)_ — Parents : scores from STAI - **Depression** _(time frame: During the one day of assessments)_ — Parents : scores from BDI - **Self-esteem** _(time frame: During the one day of assessments)_ — Parents : scores from SPP-Adult - **Emotion regulation for parents and children over the age of 18** _(time frame: During the one day of assessments)_ — Scores from ERQ - **Emotion regulation for Children and adolescents aged 8 to 17** _(time frame: During the one day of assessments)_ — Scores from ERQ-CA - **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 - **Empathy for Children 8-11 years** _(time frame: During the one day of assessments)_ — Scores from BES-C - **World vision** _(time frame: During the one day of assessments)_ — Parents and children : scores from WAS - **Well being** _(time frame: During the one day of assessments)_ — Parents and children : score from WHO-5 - **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 - **Social support** _(time frame: During the one day of assessments)_ — Parents : scores from Social Support Questionnaire - **Cognitive avoidance** _(time frame: During the one day of assessments)_ — Parents and children : scores from QEC - **Bonding** _(time frame: During the one day of assessments)_ — Parents and children : scores from PBI - **Familial functionning** _(time frame: During the one day of assessments)_ — Parents and children :Scores from the FAD-SF - **Parenting style and practices** _(time frame: During the one day of assessments)_ — Parents and children : Scores from the APQ - **Communication about 13-11 Event** _(time frame: During the one day of assessments)_ — Parents and children : results from Communication about 13-11 Event Interview - **Attention** _(time frame: During the one day of assessments)_ — Parents and children : scores from the Attentional Network Test - **Transmission of traumatic memory** _(time frame: During the one day of assessments)_ — Parents and children : results from the Approach-Avoidance Task - **Executive functionning** _(time frame: During the one day of assessments)_ — Children : scores from BRIEF - **Cortisol** _(time frame: 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** _(time frame: During the one day of assessments)_ — Scores from SDSC - **Sleep - questionnaires for Parents and children over the age of 18** _(time frame: During the one day of assessments)_ — Scores from PSQI - **Sleep - questionnaires for Parents and children over the age of 18** _(time frame: During the one day of assessments)_ — Scores from ISI - **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). - **Sleep - planner Parents and children** _(time frame: One week before the one day of assessments)_ — Evalustion of the sleep diary - **Neuroanatomical analysis** _(time frame: During the one day of assessments)_ — Parents and children : anatomic MRI with the classic anatomical sequences - **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 ## Locations (1) - Umr-S 1077 Nimh, Caen, France — _RECRUITING_ ## Recent Field Changes (last 30 days) - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.umr-s 1077 nimh|caen||france` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07203443.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07203443* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*