Early Intervention After Traumatic Exposure in Children and Adolescents: a Randomized Controlled Trial of the Effectiveness of Child and Family Traumatic Stress Intervention (CFTSI).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Evolution of post-traumatic stress symptoms before and after the Child and Family Traumatic Stress Intervention (CFTSI)
研究概览
简要总结
The aim of this interventional research is to evaluate the effectiveness of CFTSI in reducing post-traumatic symptoms measured using the CPC, child version, at the end of CFTSI treatment in children and adolescents aged between 7 and 17 years, exposed to an ET in the last 3 months. The main question(s) it aims to answer [is/are]:
- CFTSI reduces posttraumatic Child Posttraumatic Stress Checklist (CPC) scores in children exposed to ET, both immediatly after completion of the CFTSI and at 3 months after completion.
- CFTSI reduces post-traumatic scores in parents on the PTSD Checklist for DSM5 (PCL), both immediatly after completion of the CFTSI and at 3 months after completion.
- researchers will compare the reduction in post-traumatic symptoms between participants receiving CFTSI and those receiving non-specific child-centred psychological support. Symptoms will be assessed using the PCL in parents and the CPC in children and adolescents, immediately after completion of the program and again at 3 months after completion.
The participants will be randomised into two groups, one that will undergo CFTSI and one that will undergo supportive psychological therapy. Each participant will receive one session per week over five weeks, and possibly 1 to 3 additional sessions if necessary over a further three weeks, and will then be reviewed three months later.
详细描述
Individuals and populations worldwide are exposed to extremely high rates of maltreatment, violence, sexual and physical abuse, bullying, severe accidents, and exposure to other traumatic events (TE) such as natural disasters, terrorist attacks, war, and forced migration. The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) defines a traumatic event as any situation involving "actual or threatened death, serious injury, or sexual violence". A report based on epidemiological data from 24 different countries found that 70% of the populations studied worldwide report exposure to at least one TE in their lifetime. This exposure is more frequently observed among children, adolescents, and young adults, with 60% of youth under 18 having experienced at least one TE in the past year.
Childhood traumatic exposure is associated with an increased risk of developing Post-Traumatic Stress Disorder (PTSD) as well as other psychiatric disorders (depression, anxiety, suicidal behavior, addictions) and somatic issues that persist into adulthood. Psychological trauma can interfere with a child's psycho-affective, cognitive, and identity development, as well as with learning processes. Furthermore, trauma also affects the child's environment and family, disrupting family dynamics, relationships within the nuclear and extended family, as well as the mental health of parents and siblings. Traumatic exposure particularly impacts children and adolescents with pre-existing neurodevelopmental disorders (NDD) (e.g., Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, specific learning disorders) and complicates their responses and engagement with their usual treatment. This is especially critical, as children with NDD are at a higher risk than the general population for maltreatment, abuse, and/or bullying .
A meta-analysis of 27 studies on PTSD in children aged 5 to 18 shows that for some exposed individuals, there is spontaneous resolution in the months following the traumatic exposure: the prevalence of PTSD in the acute phase, one month after TE, was 21%, decreasing to 15% at three months, then to 12% and 11% at six months and one year after the TE, respectively. However, given the high rates of exposure, the percentage of children at risk of developing PTSD or associated disorders remains significant. Additionally, symptoms appearing in the acute phase, such as intrusive thoughts and irritability, cause distress for the child and their family and may lead to functional impairment, interfering with optimal development.
It is currently understood that multiple individual and contextual factors before and after traumatic exposure can either facilitate or hinder the remission of acute stress symptoms and the development of PTSD and other associated disorders. A history of traumatic exposure or neurodevelopmental disorder, younger age at the time of the TE, female gender, the nature of the TE involving intentional violence by one person against another, and post-traumatic symptoms in parents are all associated with more severe post-traumatic reactions, a higher risk of developing PTSD, and a lower response to proposed treatments. Furthermore, social and family support has been shown to be a key protective factor, facilitating the management of post-traumatic reactions following a TE and preventing the onset of PTSD in children and adolescents. It is well established that parents or primary attachment figures play a crucial role in helping children build resilience in the face of adversity. A literature meta-analysis examining the role of parental behavior in the development of PTSD in children revealed that negative parenting (hostility, overprotection) is significantly associated with child PTSD. Additionally, involvement in (or reactions to) events that impact their children can be traumatic for parents themselves, which may, in turn, affect their ability to effectively support their child at a time when the child is particularly vulnerable.
There is thus a crucial need for early and effective interventions to reduce the functional impact on development and to optimize the adaptive capacities of parents and children. Detecting traumatic situations and providing care in the wake of acute traumatic exposure or upon discovery of such exposure is essential to ensure favorable post-traumatic adjustment and prevent progression to psychotraumatic syndrome and other associated disorders, in addition to alleviating acute distress and functional impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 7 and 17 years living in the family home;
- •Having been exposed to a traumatic event (TE) in the last 3 months;
- •Exhibiting at least one symptom on the Child Post-Traumatic Stress Checklist (CPC);
- •Having at least one of the two parents available to participate in the intervention; and
- •Having a good command of French, both orally and in writing.
- •No participation in other therapeutic interventions aimed at treating traumatic stress symptoms is allowed during the inclusion period.
排除标准
- •Parents and/or children in acute and severe emotional distress and/or in a suicidal crisis. During the recruitment interview and signing of the consent letter, the principal investigator will ensure that the volunteer participants are not in acute suicidal crisis or in severe emotional distress requiring urgent care, which would prevent them from participating in a five-session intervention (CFTSI). This emotional distress assessment will be a clinical evaluation based on the clinician's judgment.
- •Child in foster care or in the process of being placed.
- •Suspected maltreatment or abuse of any kind by the parents.
- •Child and/or parent with a known and/or documented intellectual disability.
- •Absence of consent from either of the child's parents or the child's non-agreement to participate (appropriately obtained according to the child's developmental age, taking the time to explain the procedure and intervention to the child).
研究组 & 干预措施
CFTSI group
CFTSI, a 5-session intervention of 1.5 hours each, with one session per week, will be implemented in the experimental group by psychotherapists trained in CFTSI. CFTSI is a brief, structured, and standardized intervention that includes an initial session with the parents alone, a second session with the child alone, and three family sessions. Additionally, 1 to 3 extra sessions may be conducted as needed to clarify certain points or review specific strategies in detail). There is a detailed CFTSI manual describing the progression of each session and precise questionnaires used in each session to measure the intensity and frequency of symptoms, as well as their progression over time.
干预措施: CFTSI (Child and Family Traumatic Stress Intervention) (Behavioral)
Control group
The control group will undergo five sessions of 1.5 hours each, with one weekly session, of non-specific psychological support therapy, focused on the child rather than the family, and aimed at supporting the child and strengthening their daily adaptation. This support therapy is already integrated into the standard practice of the CRPOCC, but will be conducted by psychotherapists from the Montpellier University Hospital who are not trained in CFTSI, to ensure a consistent format that facilitates comparisons between the two groups. The number of sessions may be increased to a total of eight sessions if the clinician determines that additional aspects need to be addressed during the sessions.
干预措施: non-specific psychological support therapy (Behavioral)
结局指标
主要结局
Evolution of post-traumatic stress symptoms before and after the Child and Family Traumatic Stress Intervention (CFTSI)
时间窗: Baseline, immediately after completion of the program, and 3 months after completion of the program.
Assessed by the variation in total symptom scores on the Child Posttraumatic Stress Checklist (CPC), child version. This scale is validated in French, with strong psychometric properties. The original English version was designed in accordance with DSM-5 diagnostic criteria. This questionnaire assesses PTSD symptoms and their frequency in children aged 7 to 18, following a traumatic event. The minimum age of 7 years has been maintained since the original validation of the English version. The total score can range from 0 (no symptoms) to 84 (maximum symptoms) for symptom intensity and from 0 (no functional impact) to 24 (maximum functional impact) for functional impairment.
次要结局
- Correlation between Child Posttraumatic Stress Checklist (CPC) total score and parental trauma exposure (LEC-5)(Baseline)
- Evolution of post-traumatic stress symptoms in children at baseline, immediately after completion of the program, and 3 months after completion of the program.(Baseline, immediately after completion of the program, and 3 months after completion of the program.)
- Evolution of post-traumatic stress symptoms in parents, at baseline, immediately after completion of the program, and 3 months after completion of the program.(Baseline, immediately after completion of the program, and 3 months after completion of the program.)
- Correlation between Child Posttraumatic Stress Checklist (CPC) total score (child version) and variables from a socio-demographic and developmental questionnaire(Baseline)
- Correlation between Child Posttraumatic Stress Checklist (CPC) total score and presence of a pre-existing psychiatric or neurodevelopmental disorder prior to the traumatic event (TE)(Baseline)
- Correlation between Child Posttraumatic Stress Checklist (CPC) total score and trauma history(Baseline)
- Correlation between Child Posttraumatic Stress Checklist (CPC) total score and parental Post-Traumatic Stress Disorder (PTSD) symptoms (PCL-5) at baseline(Baseline)
- Correlation between Child Posttraumatic Stress Checklist (CPC) total score and Child and Youth Resilience Measure (CYRM-28) child version(Baseline, immediately after completion of the program, and 3 months after completion of the program.)
- Correlation between Child Posttraumatic Stress Checklist (CPC) total score (child version) and data from a socio-demographic and developmental questionnaire(Baseline)
- Correlation between Child Posttraumatic Stress Checklist (CPC) total score and the presence of traumatic exposures prior to the current traumatic event (TE)(Baseline, immediately after completion of the program, and 3 months after completion of the program.)
- Correlation between Child Posttraumatic Stress Checklist (CPC) total score and parental Post-Traumatic Stress Disorder (PTSD) symptoms (PCL-5)(Baseline, immediately after completion of the program, and 3 months after completion of the program.)
- Correlation between Child Posttraumatic Stress Checklist (CPC) total score and parental presence during the program(Immediately after completion of the program, and 3 months after completion of the program.)
- Correlation between Child Posttraumatic Stress Checklist (CPC) total score and time elapsed before Child and Family Traumatic Stress Intervention (CFTSI) implementation(Baseline, immediately after completion of the program, and 3 months after completion of the program.)
- Mean change in Post-Traumatic Stress Disorder (PTSD) symptoms (PTSD-Rating Index) during Child and Family Traumatic Stress Intervention (CFTSI) sessions(During the program period (weekly for 5 weeks))
- Mean change in Mood and Feelings Questionnaire (MFQ) score(During the program period (weekly for 5 weeks).)
- Concordance between child- and parent-reported post-traumatic symptoms via Child Posttraumatic Stress Checklist (CPC) child and parent version(Baseline, immediately after completion of the program, and 3 months after completion of the program.)
- Concordance between child- and parent-reported child's perception of social support and skills via Child and Youth Resilience Measure (CYRM) child and parent version(Baseline, immediately after completion of the program, and 3 months after completion of the program.)