A Feasibility and Efficacy Study of NeuroTrainer Cognitive Training in Students With and Without Attention-Related Difficulties
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 155
- 试验地点
- 6
- 主要终点
- NIH Toolbox Flanker Inhibitory Control and Attention Test (RT)
研究概览
简要总结
This clinical trial aims to evaluate the feasibility and efficacy of NeuroTrainer cognitive training in improving attentional and executive control functions in students with and without attention-related difficulties.
详细描述
The goal of this clinical trial is to test the feasibility and efficacy of NeuroTrainer cognitive training in improving attentional and executive control function in students with and without attention-related difficulties. The main questions it aims to answer are (1) does NeuroTrainer improve attentional and executive control function, (2) does NeuroTrainer engage the target of ADHD inattention symptoms by identifying the target and demonstrating proximal changes in it, and (3) does NeuroTrainer demonstrate transfer of skill with improvement in academic behaviors. Researchers will compare students who use NeuroTrainer to a control condition to see if the NeuroTrainer intervention produces significant improvements.
Participants in the intervention group will engage in virtual reality (VR) sessions which include physical activity and cognitive training. Cognitive training will maximize time at performance thresholds and optimize for variability in task dynamics and demands.
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
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnostic criteria met ADHD for any ADHD presentation type, with severity ratings of subthreshold, moderate or severe
- •Estimated IQ of 80 or greater
- •Between 11-17 years of age
排除标准
- •Presence of suicidality
- •Presence of psychotic disorders
- •Visual or hearing impairment
- •Presence of severe depression
结局指标
主要结局
NIH Toolbox Flanker Inhibitory Control and Attention Test (RT)
时间窗: Week 1, Month 2, Month 3, Month 9
This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the reaction time (RT) outcome from this assessment.
NIH Toolbox Flanker Inhibitory Control and Attention Test (% Correct)
时间窗: Week 1, Month 2, Month 3, Month 9
This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the percent correct outcome from this assessment.
NIH Toolbox Dimensional Change Card Sort Test (Omissions)
时间窗: Week 1, Month 2, Month 3, Month 9
This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the omissions outcome from this assessment.
NIH Toolbox Flanker Inhibitory Control and Attention Test (IIV-RT)
时间窗: Week 1, Month 2, Month 3, Month 9
This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the intraindividual variability of RT (IIV-RT) outcome from this assessment.
NIH Toolbox List Sorting Working Memory Test
时间窗: Week 1, Month 2, Month 3, Month 9
This test serves as an evaluation of an individual's working memory capabilities. Participants will be presented with different stimuli visually and audibly, and they will be asked to recall and sequence them accordingly. The test takes approximately 7 minutes to complete.
NIH Toolbox Dimensional Change Card Sort Test (% Correct)
时间窗: Week 1, Month 2, Month 3, Month 9
This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the percent correct outcome from this assessment.
NIH Toolbox Dimensional Change Card Sort Test (RT)
时间窗: Week 1, Month 2, Month 3, Month 9
This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the response time (RT) outcome from this assessment.
NIH Toolbox Dimensional Change Card Sort Test (IIV-RT)
时间窗: Week 1, Month 2, Month 3, Month 9
This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the intraindividual variability of RT (IIV-RT) outcome from this assessment.
NIH Toolbox Pattern Comparison Processing Speed Test
时间窗: Week 1, Month 2, Month 3, Month 9
This is an assessment of processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same. The test takes approximately 4 minutes to complete.
次要结局
- Academic Performance Rating Scale (APRS)(Week 1, Month 2, Month 3, Month 9)
- ADHD Rating Scale-5 (ADHD:RS-5) - Impulsivity/Hyperactivity Subscale(Week 1, Month 2, Month 3, Month 9)
- ADHD Rating Scale-5 (ADHD:RS-5) - Inattention Subscale(Week 1, Month 2, Month 3, Month 9)
研究者
Jeff Nyquist
Chief Science Officer
NeuroTrainer