Exploration of ETS Effects on Child Behavior and Sleep

探索 ETS 对儿童行为和睡眠的影响

• 批准号: 6768365
• 负责人: KIMBERLY YOLTON
• 金额: $ 19万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-01 至 2006-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6768365
• 关键词: air filtration; asthma; behavioral /social science research tag; biomarker; child behavior disorders; clinical research; clinical trials; comorbidity; data collection; environmental exposure; human subject; longitudinal human study; mathematical model; middle childhood (6-11); outcomes research; passive smoking; questionnaires; sleep disorders

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.

描述（由研究人员提供）：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）可能在儿童行为问题和睡眠模式中发挥的作用。该研究使用参加双盲，安慰剂对照试验（R01-HL6573101）的儿童研究了ETS暴露降低哮喘症状的益处。 6-11岁的232名儿童已经诊断出哮喘，每天至少在他们的家中暴露于至少5支香烟。减少对ETS的暴露的干预措施包括2个高效率空气过滤设备（HEPA-CPZ）或家庭中不活动（安慰剂）单位的放置时间为12个月。在基线，6个月和12个月内收集ETS暴露（血清和毛发氨酸）和空气尼古丁的急性和慢性生物学测量，以评估接触ETS。在整个研究期间，都监测哮喘症状和严重程度。拟议的研究利用基线时采取的其他（未资助的）措施来评估儿童行为变化（由父母和教师评级），儿童睡眠习惯以及护理环境的素质。这项研究将是第一个双盲，随机，安慰剂对照试验，利用被动措施，探讨ET在哮喘儿童中行为问题和睡眠模式发展中的作用。我们要求使用24个月的支持来探索这些数据。我们将通过对随机试验的意向性治疗分析来探讨ET在行为和睡眠问题上的直接关系。我们还将探索从ETS暴露于行为和睡眠问题的潜在因果途径，并考虑中介变量，例如哮喘的严重性和护理环境的特征，购买采用结构方程建模技术购买。我们将重点介绍以下目标： 1：探索通过暴露的生物标志物衡量的ETS暴露之间的关系，以及一群哮喘儿童的行为问题，这些儿童暴露于他们家中的ETS。 2：探索通过暴露的生物标志物衡量ETS暴露之间的关系，并在患有哮喘的儿童中的睡眠模式衡量，他们在家里暴露于ETS。 3：探索ETS暴露与儿童行为和睡眠模式的干扰之间的途径，并考虑使用从未在检查ETS效应中使用的结构方程建模技术，例如哮喘的严重程度和护理环境的特征等中介因素。 这项提出的分析提供了一个独特的机会，可以通过在严格的双盲，随机试验中收集的数据来探索暴露于ETS与行为与睡眠问题之间的因果途径，以减少哮喘儿童的ETS暴露。