RecruitingNot Applicable

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

France960 participantsStarted 2024-12-17

Plain-language 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).

Who can participate

Age range

9 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 writ…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of Psychiatric nosography with MINI (parents)

Timeframe: During the one day of assessments

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

Timeframe: During the one day of assessments

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

Timeframe: During the one day of assessments

Assessment of PTSD symptoms severity in adults

Timeframe: During the one day of assessments

Secondary traumatisation

Timeframe: During the one day of assessments

Post-traumatic growth

Timeframe: During the one day of assessments

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

Timeframe: During the one day of assessments

Trial details

NCT IDNCT07203443

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

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-01-15

View on ClinicalTrials.gov More Intergenerational Trauma trials

Plain-language summary

Who can participate

Age range

9 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Assessment of Psychiatric nosography with MINI (parents)

Timeframe: During the one day of assessments

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

Timeframe: During the one day of assessments

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

Timeframe: During the one day of assessments

Assessment of PTSD symptoms severity in adults

Timeframe: During the one day of assessments

Secondary traumatisation

Timeframe: During the one day of assessments

Post-traumatic growth

Timeframe: During the one day of assessments

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

Timeframe: During the one day of assessments