Randomized Control Trial of Two Computer-Based Attention Training Programs in Schools for Children With Attention Deficit/Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Behavioral Observations of Students in School (BOSS)
研究概览
简要总结
This study examines the efficacy of two computer-based attention training systems, one with and one without neurofeedback. The training systems intend to help children learn to focus and attend more effectively.
详细描述
The current study is examining a neurofeedback (NF) computer attention training system that teaches children to alter their brainwave activity with a Cognitive Training attention training system (CT). The investigators hypothesize that both treatments will show improvement in ADHD symptoms and academic outcomes compared to a control condition.
104 children with ADHD in grades 2 and 4 are randomly assigned to receive the NF, CT, or a Waitlist-Control (WLC) condition that receives NF or CT the following academic year. Children receive forty 45-minute sessions three times a week at school for 4 months. A comprehensive assessment, consists of data completed by teachers, parents, participants, and double-blind classroom observations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •diagnosis of ADHD (any subtype, per report of the child's physician or school psychologist) entering 2nd or 4th grade at the beginning of September 2009 and
- •combined IQ (Intelligence Quotient) at or above 80,
- •ability to read English sufficiently to complete assessments and intervention protocols
排除标准
- •mental retardation,
- •coexisting diagnosis of conduct disorder,
- •pervasive developmental disorder, or
- •other serious mental illness (eg., bipolar disorder, psychosis, autism)
研究组 & 干预措施
Cognitive Training
干预措施: Cognitive Training (Behavioral)
Waitlist Control
干预措施: Waitlist Control (Other)
Neurofeedback
干预措施: Neurofeedback (Behavioral)
结局指标
主要结局
Behavioral Observations of Students in School (BOSS)
时间窗: up to three years
For the purpose of this study, the BOSS is a double blind classroom observation. Each participant is observed by a trained researcher for 15 minutes three times over the course of two days at each assessment point (before the intervention, after the intervention, and at a 6-month follow up) and is evaluated in the areas of off task behaviors (motor, verbal, and passive) and on task behaviors (active and passive).
次要结局
未报告次要终点