Randomized Controlled Trial of Executive Function Training in Preterm Children at Risk for Inattention, Hyperactivity and Executive Function Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change from baseline on Executive Function Composite Measure at 2 months
研究概览
简要总结
The purpose of this study is to determine if different forms of child-friendly, computer-based puzzles and games ("brain training") targeting executive function (EF) skills (i.e., thinking, problem-solving) result in improvements in EF in preschool children at risk for EF problems due to premature birth. The investigators hypothesize that children receiving active "brain training" will show greater improvements in EF and related skills immediately after treatment than children receiving passive "brain training." The investigators are also interested in whether any improvements in EF and related skills occur or are maintained at 3 and 6 months after completion of brain training.
详细描述
Detailed description:
- Investigators will talk to you by telephone to determine if your child might be eligible for the study.
- Children complete two baseline testing sessions to evaluate executive function (EF) and related skills
- Parents complete a packet of information, including questionnaires about the child's behavior, EF, and functional skills.
- After completion of the baseline testing, we will inform you of eligibility for the "Brain Training" phase.
- During "Brain Training" children play online computer games for 25-30 minutes/day (can range from 15-45 minutes/day depending on your child's attention, training version received, number and length of breaks needed), 5 days a week, for 5-7 weeks to complete a total of 25 sessions.
- Children return for 3 more time points, immediately after the completion of "Brain Training" (1 session), and also at 3 months (1 session) and 6 months (2 sessions) after completion of "Brain Training."
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 4 or 5 years
- •Born prematurely at <33 weeks gestation
- •Able to comprehend task instructions
- •EF impairment on standardized questionnaire (t-score of 60 or greater) or EF battery (lower quartile)
排除标准
- •Major neurosensory impairment (i.e., blind, deaf) or technology dependence (i.e., ventilator dependent) that interferes with testing
- •Genetic syndrome
- •Inability to comprehend task instructions
结局指标
主要结局
Change from baseline on Executive Function Composite Measure at 2 months
时间窗: 2 months
EF composite measured post "Brain Training."
次要结局
- Change from baseline on Executive Function Composite Measure at 8 months(8 months)
- Change from 8-month Executive Function Composite Measure at 10 months (cross over groups)(2 months)
- Change from baseline on Executive Function Composite Measure at 5 months(5 months)
- Change from baseline on Early Academic Skills Measures at 8 months(8 months)
研究者
Irene M. Loe, MD
Principal Investigator
Stanford University