Efficacy of Visual Focusing Game on Children With Attention Deficit Hyperactivity Disorder and Mechanisms of Functional Near-Infrared Spectroscopic Imaging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Change in Attention Deficit Hyperactivity Disorder Rating Scale scores between baseline and post-treatment
研究概览
简要总结
This is a single-center, randomized, double-blind, sham-controlled study that will recruit children with attention deficit hyperactivity disorder and randomly assign them to a test group and a control group. The patients in the test group will be given a visual focus game to play and the patients in the control group will be given an animated video of the game that had no therapeutic effect. Treatment will be required at least 5 times per week for 2 weeks, with each game or video session lasting 30 minutes. Clinical scales and functional near-infrared spectroscopic imaging will be performed before and at the end of the 2 weeks of treatment, respectively.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnostic criteria for ADHD in the U.S. Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5);
- •Aged 6-14 years old;
- •Right-handedness (habitual or good use of the right hand in daily life, work, study and labor activities);
- •Voluntarily agree to sign an informed consent form;
排除标准
- •Wechsler Intelligence Scale for Children (WISC) <80 points;
- •The cranial CT or MRI found that there are clear infarction foci, soft foci, occupations and other organic lesions;
- •Suffering from serious physical diseases or other severe mental diseases, such as schizophrenia, bipolar disorder, etc;
- •Inability to cooperate with fNIRS data collection
结局指标
主要结局
Change in Attention Deficit Hyperactivity Disorder Rating Scale scores between baseline and post-treatment
时间窗: Baseline and 2 weeks
The Attention Deficit Hyperactivity Disorder Rating Scale is commonly used to determine whether children have symptoms of ADHD, how severe they are, and how impaired they are. As such, it is a combination of symptom and functional impairment ratings (e.g., unless it is at least moderately impaired to rate a 2 or 3 on a symptom). This is usually done by the clinician based on information provided by the parent/guardian or teacher.
次要结局
- Change in the Parent Symptom Questionnaire scores between baseline and post-treatment(Baseline and 2 weeks)
- Changes in Functional Near-Infrared Spectral Imaging between Baseline and Post-Treatment(Baseline and 2 weeks)