NCT06446193已完成不适用
A Multi-center, Randomized, Assessor-blind, Superiority, Confirmatory Clinical Trial to Assess Safety and Efficacy of Cognitive Therapy Software 'NDTx-01' for Improving Social Awareness and Interaction in Children and Adolescents With Autism Spectrum Disorder (ASD) or Social Communication Disorder (SCD)
Neudive Inc.10 个研究点 分布在 2 个国家目标入组 86 人开始时间: 2024年8月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 10
- 主要终点
- Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 42
研究概览
简要总结
The purpose of this study is to demonstrate the superiority of the treatment of cognitive therapy software 'NDTx-01' compared to TAU (Treatment-As-Usual).
详细描述
This confirmatory clinical trial aims to demonstrate the superiority of 'NDTx-01' by comparing and evaluating the efficacy and safety of the experimental group applying 'NDTx-01' with TAU (Treatment-As-Usual) and the control group applying TAU only.
The study participants will be randomized in a 1:1 as experimental group and control group. The experimental group applies 'NDTx-01' 30 times for 6 weeks (5 times a week) with TAU and the control group gets TAU only. For the primary purpose, the change in the adaptive behavior combination (ABC) score of the Korean version of the Vineland Adaptive Behavior Scale-II (K-VABS-II) at 42 days compared to the baseline will be evaluated.
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 (Outcomes Assessor)
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
- •Children and adolescents between the ages of 10 and 18
- •Diagnosed with autism spectrum disorder (ASD) or social communication disorder (SCD) based on the clinical judgment of a psychiatrist according to DSM-5 diagnostic criteria
- •Participants who are able to install 'NDTx-01' on an Android smartphone and use it alone or with the help of their guardian
- •Participants who are able to comply with the recommended application time for the investigational medical device (6 weeks, 30 times, 5 times a week)
- •Participants who have agreed not to use any other medical devices besides the investigational medical device during the clinical trial
- •Participants who agree that there should be no change in the use of drugs which can significantly affect one's sociality during the clinical trial (If there is a drug being taken during screening, it can be taken continuously, but the total daily dose, ingredients, etc., should remain unchanged until the end of the study visit.)
- •Participants who agree not to participate in other Applied Behavior Analysis (ABA) treatment/rehabilitation/education, social treatment/rehabilitation/education program (If there is treatment/rehabilitation/education being received during screening, it can be received continuously, but the number of applications and treatment methods should remain unchanged until the end of the study visit.)
- •Participants who and whose parents (legal guardians) have volunteered to participate in this clinical trial and have given written consent to the subject description and consent form
- •Participants willing to comply with the clinical trial procedures
排除标准
- •A risk of clinically significant behavioral problems, emotion regulation problems, psychotic symptoms, self-harm, or other harm at a level that affects the treatment process
- •Severe acute/chronic medical or mental illness
- •Serious trauma or surgery performed within 4 weeks before the screening date
- •Participants with other disabilities such as severe neurological diseases (e.g. brain lesions, mental disorders, etc.)
- •Participants who are currently participating in another clinical trial or have participated in another clinical trial within 30 days before the screening date
- •Participants with a previous history of using NDTx-01, the investigational device
- •Participants who have a change in the usage or dosage of drugs which can significantly affect one's sociality, or a change in participation in treatment/rehabilitation/education programs that can significantly affect one's sociality within 8 weeks before the baseline date of the clinical trial
- •In other cases where the investigator determines that participation in the clinical trial is inappropriate due to ethical reasons or the possibility of influencing the results of the clinical trial
研究组 & 干预措施
The control group
Other
TAU (Treatment-As-Usual)
干预措施: TAU (Behavioral)
The experimental group
Experimental
NDTx-01 + TAU (Treatment-As-Usual)
干预措施: TAU (Behavioral)
结局指标
主要结局
Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 42
时间窗: Baseline, Day 42
The K-VABS-II is a tool used to assess adaptive behavior and functioning in individuals from birth to 99 years old. It evaluates personal and social skills necessary for everyday living. The scores (standard scores) range from 55 to 145, with higher scores indicating better outcomes.
次要结局
- Change from Baseline in Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 28(Baseline, Day 28)
- Change from Baseline in K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ) at Day 28 and Day 42(Baseline, Day 28, Day 42)
- Change from Baseline in SRS-2 (Korean Social Responsiveness Scale-2) at Day 28 and Day 42(Baseline, Day 28, Day 42)
- Change from Baseline in K-PRQ-CA (Korean Parenting Relationship Questionnaire - Child & Adolescent) at Day 28 and Day 42(Baseline, Day 28, Day 42)
- Change from Baseline in KIPR (Korean Inventory of Peer Relationships) at Day 28 and Day 42(Baseline, Day 28, Day 42)
- Change from Baseline in EQ-5D-5L (EuroQol Five Dimension Five Level Scale) at Day 42(Baseline, Day 42)
- Change from Baseline in CGI-S (Clinical Global Impression-Severity) at Day 28 and Day 42(Baseline, Day 28, Day 42)
- CGI-I (Clinical Global Impression-Improvement) at Day 28 and Day 42(Day 28, Day 42)
- NDTx-01 Satisfaction Questionnaire at Day 42(Day 42)
研究者
研究点 (10)
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