Child Cognitive-Affective Resilience Following 13-11 Event : A Pluridisciplinary Study of Intergenerational Transmission of a Traumatic Event
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 960
- 试验地点
- 2
- 主要终点
- Self-esteem
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exposed group
- •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 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
- •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
- •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
- •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 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 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
排除标准
- •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
结局指标
主要结局
Self-esteem
时间窗: During the one day of assessments
Parents : scores from SPP-Adult
Emotion regulation for parents and children over the age of 18
时间窗: During the one day of assessments
Scores from ERQ
Emotion regulation for Children and adolescents aged 8 to 17
时间窗: During the one day of assessments
Scores from ERQ-CA
Empathy for Parents, chidren 12-17 years and children over the age of 18
时间窗: During the one day of assessments
Scores from BES-A
Empathy for Children 8-11 years
时间窗: During the one day of assessments
Scores from BES-C
World vision
时间窗: During the one day of assessments
Parents and children : scores from WAS
Well being
时间窗: During the one day of assessments
Parents and children : score from WHO-5
Assessment of Psychiatric nosography with CBCL/YSR (children)
时间窗: 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
时间窗: During the one day of assessments
Parents : scores from Social Support Questionnaire
Cognitive avoidance
时间窗: During the one day of assessments
Parents and children : scores from QEC
Familial functionning
时间窗: During the one day of assessments
Parents and children :Scores from the FAD-SF
Bonding
时间窗: During the one day of assessments
Parents and children : scores from PBI
Parenting style and practices
时间窗: During the one day of assessments
Parents and children : Scores from the APQ
Communication about 13-11 Event
时间窗: During the one day of assessments
Parents and children : results from Communication about 13-11 Event Interview
Attention
时间窗: During the one day of assessments
Parents and children : scores from the Attentional Network Test
Transmission of traumatic memory
时间窗: During the one day of assessments
Parents and children : results from the Approach-Avoidance Task
Cortisol
时间窗: During the morning of the one day of assessments
Parents and children : Cortisol Awakening Response
Executive functionning
时间窗: During the one day of assessments
Children : scores from BRIEF
Sleep - questionnaires for children 8-11 and 12-17 years
时间窗: During the one day of assessments
Scores from SDSC
Sleep - questionnaires for Parents and children over the age of 18
时间窗: During the one day of assessments
Scores from PSQI
Sleep - actimetry Parents and children
时间窗: 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
时间窗: One week before the one day of assessments
Evalustion of the sleep diary
Neuroanatomical analysis
时间窗: During the one day of assessments
Parents and children : anatomic MRI with the classic anatomical sequences
Neurofunctional analysis
时间窗: During the one day of assessments
Parents and children fonctionnal MRI with the measurement of the magnitude of the BOLD signal
Assessment of Psychiatric nosography with MINI (parents)
时间窗: During the one day of assessments
Psychological interview
Assessment of PTSD symptoms severity in children 8-11 years and 12-17 years
时间窗: 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
时间窗: 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
时间窗: During the one day of assessments
Scores from PCL-5 which is a self report measure
Coping skills for parents and children 8-11 years
时间窗: During the one day of assessments
Scores from SRCS.
Secondary traumatisation
时间窗: During the one day of assessments
Parents and children : Scores from FST
Post-traumatic growth
时间窗: During the one day of assessments
Parents : Scores from PTGI
Coping skills for parents, children 12-17 years and over the age of 18
时间窗: During the one day of assessments
Scores from BCI
Resilience for children 8 to 11 years old
时间窗: During the one day of assessments
Scores from CYRM-R-Child
Resilience for parents and children over the age of 18
时间窗: During the one day of assessments
Scores from ARM-R
Resilience for children 12 to 17 years old
时间窗: During the one day of assessments
Scores from CYRM-R-Youth
Attachment
时间窗: During the one day of assessments
Children : Scores from IPPA
Anxiety
时间窗: During the one day of assessments
Parents : scores from STAI
Depression
时间窗: During the one day of assessments
Parents : scores from BDI
次要结局
未报告次要终点