Exploration of ETS Effects on Child Behavior and Sleep

描述（由研究者提供）：本研究将采用新的研究设计和分析方法来探讨环境烟草烟雾（ETS）在儿童行为问题和睡眠模式中的作用。该研究纳入了一项双盲安慰剂对照试验（R01-HL6573101），研究减少ETS暴露对哮喘症状的益处。232名年龄在6-11岁之间的儿童被医生诊断患有哮喘，并且每天在家中至少接触5支香烟。减少ETS暴露的干预措施包括在家中放置2个高效空气过滤装置（HEPA-CPZ）或无活性（安慰剂）装置，为期12个月。在基线、6个月和12个月收集ETS暴露（血清和头发可替宁）和空气尼古丁的急性和慢性生物学测量，以评估ETS暴露。在整个研究期间监测哮喘症状和严重程度。拟议的研究利用在基线和研究结束时收集的额外（非资助）措施来评估儿童行为变化（由父母和老师评分），儿童睡眠习惯和护理环境的质量。本研究将是首个双盲、随机、安慰剂对照试验，利用被动测量方法，探索ETS在哮喘儿童行为问题和睡眠模式发展中的作用。我们要求24个月的支持，以探索这些数据。我们将通过对随机试验的意向治疗分析来探索ETS与行为和睡眠问题的直接关系。此外，我们将采用结构方程建模技术，考虑哮喘严重程度和护理环境特征等中介变量，探索ETS暴露与行为和睡眠问题之间的潜在因果关系。我们将着重实现以下目标：

DESCRIPTION (provided by investigator): This study will employ new research design and analytical methods to explore the role that environmental tobacco smoke (ETS) may play in the behavior problems and sleep patterns of children. The study uses children enrolled in a double blind, placebo controlled trial (R01-HL6573101) investigating the benefits of ETS exposure reduction on asthma symptoms. The 232 children, aged 6-11 years, have doctor-diagnosed asthma and are exposed to at least 5 cigarettes per day in their homes. Intervention to reduce exposure to ETS consists of placement of 2 high efficiency air filtration devices (HEPA-CPZ) or inactive (placebo) units in the home for a period of 12 months. Acute and chronic biological measures of ETS exposure (serum and hair cotinine) and air nicotine are collected at baseline, 6 months, and 12 months, to assess exposure to ETS. Asthma symptoms and severity are monitored throughout the study period. The proposed study utilizes additional (non-funded) measures collected at baseline and study termination to assess child behavior changes (rated by parents and teachers), child sleep habits, and qualities of the care-giving environment. This study will be the first double blind, randomized, placebo-controlled trial, utilizing passive measures, to explore the role of ETS in the development of behavior problems and sleep patterns among children with asthma. We request 24 months of support with which to explore this data. We will explore the direct relationships of ETS on behavior and sleep problems through an intention-to-treat analysis of the randomized trial. We will additionally explore the potential causal pathways from ETS exposure to behavior and sleep problems, with consideration of mediating variables such as asthma severity and characteristics of the care-giving environment, buy employing structural equation modeling techniques. We will focus on the following aims: 1: To explore the relationship between ETS exposure, as measured by biomarkers of exposure, and behavior problems in a cohort of children with asthma who are exposed to ETS in their homes. 2: To explore the relationship between ETS exposure, as measured by biomarkers of exposure, and sleep patterns in a cohort of children with asthma who are exposed to ETS in their homes. 3: To explore the pathways between ETS exposure and disturbances in child behaviors and sleep patterns with consideration of mediating factors such as asthma severity and characteristics of the care-giving environment using structural equation modeling techniques that have never been used in examining the effects of ETS. This proposed analysis offers a unique opportunity to explore the causal pathway between exposure to ETS and behavior and sleep problems of children through data collected during a rigorous double blind, randomized trial to reduce ETS exposure among children with asthma.