Cognitive Rehabilitation in Pediatric Acquired Brain Injury - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- executive function in daily life
研究概览
简要总结
Acquired brain injury (e.g., traumatic brain injury, brain tumour, brain infections) is one of the leading causes of death and disability for children and adolescents. Importantly, injuries affecting the brain in childhood or adolescence appear during a time of development when the brain is particularly vulnerable. Thus, pediatric acquired brain injury does not only impact cognitive functions at the time of injury or onset of disease, but also cognitive functions that are yet to develop. Changes in cognitive function, and in particular executive dysfunction due to acquired brain injury, cause significant real-life disability, yet solid evidence in support of executive functioning interventions for children and adolescents is lacking. In the present study different group-based cognitive rehabilitation interventions will be compared. The aim of the study is to investigate if a group-based "brain training" intervention is able to improve executive function in children and adolescents after acquired brain injury. Efficacy will be assessed immediately after intervention, but also six months after the intervention. The project is in line with international research efforts aimed at establishing more knowledge about how children and adolescents with brain injuries respond to cognitive rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with traumatic brain injury, brain tumor or damage by inflammation in the brain
- •more than 12 months since injury/illness or more than 12 months since ended cancer therapy
- •evidence of executive dysfunction in everyday life
排除标准
- •cognitive, sensory, physical, or language impairment affecting the capacity to attend mainstream school and/or complete the training program
- •pre-injury neurological disease or psychiatric disorder
- •recently detected brain tumor relapse
- •unfit for evaluation of outcome (independent evaluation by 2 investigators)
- •not fluent in Norwegian language
结局指标
主要结局
executive function in daily life
时间窗: change from baseline up to 6 months
Behavior Rating Inventory of Executive Function (BRIEF; self, teacher and parent form
次要结局
- Performance on BADS-C(change from baseline up to 6 months)
- Score on Pediatric Quality of Life Inventory(change from baseline up to 6 months)
- Score on ADHD Rating Scale IV(change from baseline up to 6 months)
- Score on Child Behavior Checklist(change from baseline up to 6 months)
- Performance on D-KEFS Trail Making Test 1-4(change from baseline up to 6 months)
- performance on D-KEFS Color Word Interference Test(change from baseline up to 6 months)
- Performance on NEPSY-II Social Perception test(change from baseline up to 6 months)
- Score on Harter Self Perception Profile for Children(change from baseline up to 6 months)
- Performance on Children's Cooking Task test(change from baseline up to 6 months)
- Score an EQ-5D-Y(change from baseline up to 6 months)
- Score on Cognitive Failures Questionnaire(change from baseline up to 6 months)
- Performance on Conners Continuous Performance Test III(change from baseline up to 6 months)
- Score on Health Behaviour Inventory(change from baseline up to 6 months)
- Score on Glasgow Outcome Scale Extended Pediatric(change from baseline up to 6 months)
- Score on Center for Epidemiologic Studies Depression Scale(change from baseline up to 6 months)
- Score on Family Functioning Scale(change from baseline up to 6 months)