KCT0008403已完成Unknown
A prospective, multi-center, investigator initiated study to assess the safety and efficacy of cognitive assessment software (AttnKare-D) of computer aided diagnosis for Attention-deficit/hyperactivity disorder
Samsung Changwon Medical Center0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6(Year) 至 12(Year)（—）
- 性别
- All
入选标准
- •The eligible participants must meet all of the following criteria:
- •Individuals who are between 6 and 12 years old.
- •Individuals classified into either the disorder group or the control group according to the following criteria:
- •a) Disorder group: Individuals diagnosed with ADHD by a specialist in psychiatry.
- •b) Control group: Individuals diagnosed by a specialist in psychiatry as not having ADHD or any other mental disorder.
- •Individuals who have received sufficient explanation of this clinical trial, have understood it, and have voluntarily decided to participate and agreed to comply with the precautions.
排除标准
- •Participants who meet any of the following criteria will be excluded from this clinical trial:
- •1)Individuals diagnosed with post-traumatic stress disorder, schizophrenia and other psychiatric disorders, bipolar disorder, pervasive developmental disorders, obsessive-compulsive disorder, severe depression, or severe anxiety disorders, conduct disorder, or other similar disorders.
- •2)Individuals who are currently taking ADHD medications (e.g., methylphenidate, atomoxetine, clonidine, guanfacine) or have a history of taking them within the past month.
- •3)Individuals who have attempted suicide within the past 3 months and have been identified as a high-risk group for suicide by a mental health professional.
- •4)Individuals who have started or are undergoing other cognitive and behavioral therapy within the past 3 months, including all types of cognitive and behavioral therapies, including ADHD.
- •5)Individuals who have physical impairments (e.g., hand/arm physical deformities, prostheses) that interfere with game play, as reported by parents or observed by the participant.
- •6)Individuals who have participated in another clinical trial within 90 days before the screening.
- •7)Individuals with an IQ of 70 or lower.
- •8)Individuals with color blindness.
- •9)Individuals with uncorrected vision (as determined by the participant's ability to play the game in the clinic).
- •10)Individuals who have difficulty using common equipment (such as smartphones or tablet PCs).
- •11)Individuals who fail to complete the AttnKare-D assessment during the baseline evaluation due to the final failure.
- •12)Individuals deemed unsuitable for clinical trial participation by the investigator for any other reason.
研究者
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