Houston Independent School District (HISD) Yoga and Wellness Program Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Feasibility of Collecting Electroencephalograms (EEGs; for Brain Activity Analysis in Elementary-Aged Children Participating in a Health and Wellness Program
研究概览
简要总结
The goal of this research study is to learn about how brain activity, cognitive tests (tests of participant's brain function), and stress hormones are related to taking part in a health and wellness program in elementary-aged students.
详细描述
If participant agrees to take part in this study, they will complete an electroencephalograph (EEG -- a test that measures the electrical activity of the brain), cognitive tests, and provide a hair sample shortly after they enter the study and again near the end of the school year.
The testing will take place in a room at participant's school chosen by the teachers. A member of the study staff will walk participant from their classroom and be with them the whole time the testing is taking place and then take them back to their classroom. If the testing is done before or after school, participant will stay with the member of study staff until their parent or guardian comes to pick them up.
During the EEG, researchers will place 19 electrodes on participant's head and 1 or 2 electrodes on each earlobe. Gel will be used to help attach the electrodes. The electrodes will measure and record participant's brain wave activity, similar to the way a doctor listens to their heart beat from the surface of their skin. During the EEG, participant will be also asked to wear headphones and do some simple tests on the computer that measure their abilities to see, hear, and understand information. The EEG will take up to 5 minutes to set up and then 25 minutes for testing.
Participant will also provide a sample of hair, about 75 strands which is like the thickness of a pencil. The hair will tested to measure a stress hormone called cortisol. The hair will be destroyed after study testing.
Data obtained from the hair samples and EEG will be analyzed alongside the data participant is providing our collaborators at the University of San Diego and the Houston Independent School District.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fourth and Fifth graders in Houston Independent School District (HISD) schools that are participating in the Sonima Foundation's Health and Wellness Program
- •Participant on USD study protocol.
排除标准
- •Participants who are taking any antipsychotic medications
- •Participants with active central nervous system (CNS) disease or encephalopathy
- •Participants who have ever been diagnosed with bipolar disorder or schizophrenia
- •Participants who have a history of head injury or who have a known seizure activity.
结局指标
主要结局
Feasibility of Collecting Electroencephalograms (EEGs; for Brain Activity Analysis in Elementary-Aged Children Participating in a Health and Wellness Program
时间窗: 9 months
Trial feasible if 50% of students who are enrolled complete the EEG's.
Feasibility of Collecting Hair Samples (for Cortisol Analysis) in Elementary-Aged Children Participating in a Health and Wellness Program
时间窗: 9 months
Trial feasible if 50% of students who are enrolled submit hair samples.
次要结局
- Changes in EEG During Each State (Eyes Open, Eyes Closed, and During Cognitive Testing)(At baseline and at 9 months)