Research on the Development of Attention and Its Relationship With Emotions in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Continuous Performance Test, CPT
研究概览
简要总结
Our aim was to describe the development and usability of a mobile device-based game therapy software for ADHD.
详细描述
A total of 51 ADHD children and 52 healthy children were included in the study. At baseline, subjects underwent tests such as ADHD symptom-related scale assessments, computer-assisted information processing tests, and physiological-psychological tests, after which participants completed a 4-week game intervention training at home. After complete completion of the intervention, subjects repeated all tests from the baseline period and answered treatment satisfaction questions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ADHD-a. Age between 6-12 years, any gender.
- •ADHD-b. Outpatient patients diagnosed with ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- •ADHD-c. Patients and/or their guardians willing to participate in the study and provide informed consent. Participants aged 8 and above should also sign a child's informed consent form.
- •HC. The control group of healthy participants are recruited from a secondary school in Nanjing, matching the age and gender of the ADHD group.
排除标准
- •a. Neurodevelopmental disorders such as cerebral palsy, epilepsy, adrenoleukodystrophy, and other similar conditions.
- •b. Severe mental disorders including tic disorders, autism spectrum disorders, intellectual disability, schizophrenia, bipolar disorder, depressive disorders, specific learning disorders, and other significant psychiatric conditions.
- •c. Individuals exhibiting ADHD-like symptoms due to hearing impairments.
- •d. Requirement of any central nervous system medication (including both traditional and Western medicine as well as dietary supplements) such as antipsychotics or antidepressants at any stage of the study.
- •e. Patients who have received systematic treatment with two different categories of ADHD medications without improvement.
- •f. Individuals with color blindness or any other condition that would prevent proper use of the software.
- •g. History of or current gaming addiction.
结局指标
主要结局
Continuous Performance Test, CPT
时间窗: baseline and post (an average of 30days after baseline)
CPT software is one of the commonly used tools for examining attention and is a computer-assisted information processing test with objective results, independent of supervisors, and is the most widely used experimental paradigm in current research. The CPT paradigm adopted in this study is the presence of a white boxed area on a black background on the calculator screen, with white squares randomly appearing above or below the white boxed area, requiring the target stimulus to be a right mouse button press when the square appears below it.
次要结局
- Delay-saccade task(baseline and post (an average of 30days after baseline))
- Swanson Nolan, and Pelham-IV rating scales, SNAP-IV(baseline and post (an average of 30days after baseline))
- Strengths and Difficulties Questionnaire, SDQ(baseline and post (an average of 30days after baseline))
- Anti-saccade task(baseline and post (an average of 30days after baseline))
- Behavior Rating Inventory of Executive Function, BRIEF(baseline and post (an average of 30days after baseline))