BridgeMD
New treatment option for Intergenerational Trauma
Official title Child Cognitive-Affective Resilience Following 13-11 Event : A Pluridisciplinary Study of Intergenerational Transmission of a Traumatic Event
ClinicalTrials.gov ID: NCT07203443
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- With a good command of the French language (francophone)
- Whose parents have given written consent for their child's their child's participation
You likely can't join 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...
- 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:
See the full eligibility criteria
Who can 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
- 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
What rules you out
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Caen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Caen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.