Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline in the Post Concussion Symptoms Scale at treatment completion.
研究概览
简要总结
The purpose of this study is to investigate the role of psychosocial factors in creating Persistent Post-concussive symptoms (PPCS). The researchers investigate three hypotheses: (a) Do pre-injury psycho-environmental deficits predict a higher level of PPCS? (b) Do socio-demographic and personal pre-injury deficits relate to (1) a more negative attribution for the child injury by their parents and (2) embracing of a more permissive and authoritarian parenting; and do these factors mediate the symptoms' preservation? (c) Does Cognitive-Behavioral Therapy (CBT) benefit to reducing PPCS emotional and behavioral symptoms?
详细描述
200 children and adolescents with post concussion will be followed for 9 months, since the time of the head injury. Post concussive symptoms, along emotional distress and neurocognitive deficits will be examined at 2 weeks, 4 months and 9 months since the injury, using self report questionnaires, psychological evaluation and neuropsychological tests. Participants who demonstrates PPCS 4 months after the injury will be assigned either to the Cognitive Behavioral Treatmet group (CBT) or to the Treatment as Ususal group(TAU). The change in symptoms severity (PCS, emotional distress and neurocognitive deficits) will be compared between the two study groups in order to assess treatment efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Head trauma.
- •Post-concussive symptoms diagnosis according to DSMIV.
排除标准
- •mental retardation.
- •drug abuse.
研究组 & 干预措施
Treatment as usual (TAU)
Participants recive Psycho-education and neuro-psycological diagnosis.
Cognitive-Behavioral Therapy (CBT)
Participants recive 16 sessions of CBT in addition to arm TAU treatment.
干预措施: Cognitive-Behavioral Therapy (Behavioral)
结局指标
主要结局
Change from baseline in the Post Concussion Symptoms Scale at treatment completion.
时间窗: Approximately 9 months since injury.
PCI-I (Mittenberg, Miller \& Luis, 1997)
次要结局
- Change from Baseline in the Childrens Depression Inventory at Treatment Completion(Approximately 9 months since injury.)
- Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion(Approximately 9 months since injury.)
- Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion(Approximately 9 months since injury.)
- Change from Baseline in Neuropsychological Functioning at Treatment Subjects will take paper and pencil and computer tests to evaluate memory, learning, attention and concentration, vocabulary and naming.(Approximately 9 months since injury.)