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临床试验/NCT02358941
NCT02358941已完成不适用

Neurofeedback and Computerized Cognitive Training in Different Settings for Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD)

University of Zurich2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
2
主要终点
ADHD behavioral symptoms

研究概览

简要总结

Attention deficit/hyperactivity disorder (ADHD) is among the most common childhood-onset psychiatric disorders, with a negative and long-lasting impact on academic achievement, social integration and quality of life. In recent years, the efficacy of non-pharmacological treatments for ADHD, such as neurofeedback training (NF) and computerized cognitive training (CCT), has been at the centre of research. Although an increasing number of well-designed studies have shown that both methods may improve ADHD core symptoms according to parents' ratings, the underlying mechanisms are still a matter of debate. Teachers often report smaller improvements, if any. This has been explained by their lesser involvement in the training. It remains questionable, however, whether other factors may also account for this effect and whether methods other than placebo control may be applied in order to demonstrate the specificity and efficacy of NF and CCT.

The main purpose of this project is to demonstrate and compare the efficacy of two different computer-based treatment methods for children and adolescents with ADHD, namely NF and CCT, and to examine the impact of different treatment settings, with half of the participants being trained in a clinical setting and the other half at school. The investigators want to show that is feasible to implement NF and CCT in a school setting and that both methods, conducted either at school or in a clinical setting, may lead to significant improvements of ADHD symptoms as well as to specific and differential effects. Besides the differential impact of the settings on informant ratings, the investigators will evaluate the effects of the training methods on neuropsychological and electrophysiological outcome. Classroom behavior of the children before and after the training will be evaluated by trained observers not informed on treatment assignments and settings.

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
Single (Care Provider)

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ADHD (DSM IV)

排除标准

  • Estimated IQ < 80
  • Known neurological impairment / brain injury
  • Severe comorbid conditions (e.g. CD, ODD, autism)

结局指标

主要结局

ADHD behavioral symptoms

时间窗: Outcome assessment 6 months after baseline

Primary outcome measures will be assessed by clinical scales (Conners 3), rated by parents and teachers.

次要结局

  • Neuropsychological performance, EEG parameters(Outcome assessment 6 months after baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Renate Drechsler

PD Dr.

University of Zurich

研究点 (2)

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