Measuring Sleep Problems in Children with Autism Spectrum Disorder

测量自闭症谱系障碍儿童的睡眠问题

基本信息

批准号：
9803060
负责人：
Michael C Edwards
金额：
$ 66.79万
依托单位：
EMORY UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-13 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9803060
关键词：
Adverse effects Affect Age Agreement Anxiety Arousal Beds Behavior Behavior Therapy Behavioral Child Childhood Classification Clinic Clinical Data Clinical assessments Code Cognitive Community Surveys Data Data Reporting Development Developmental Disabilities Ensure Factor Analysis Family Focus Groups Future Habits Health Hyperactive behavior Impairment Information Systems Intervention Studies Language Language Delays Learning Linear Regressions Measurement Measures Medical Methods Modeling Monitor Monograph Ohio Outcome Outcome Measure Parents Patient Outcomes Assessments Persons Pharmaceutical Preparations Pharmacological Treatment Polysomnography Population Primary Insomnia Questionnaires Reading Receiver Operating Characteristics Reporting Research Design Research Personnel Sampling Secondary Insomnia Secure Sensitivity and Specificity Site Sleep Sleep Deprivation Sleep Disorders Sleep disturbances Sleeplessness Structure Surveys Testing Time Validity and Reliability Withdrawal Youth actigraphy adverse outcome age group autism spectrum disorder autistic children base behavior test clinical practice design emotion regulation falls immune function indexing informant patient population recruit repetitive behavior response screening side effect social theories web site

项目摘要

Project Summary / Abstract. This application, written in response to PAR-18-039, will advance outcome measurement for sleep problems in children (age 3-12 years) with Autism Spectrum Disorder (ASD). Sleep problems (e.g., sleep disturbances and sleep-related impairments) in children with ASD range from mild to severe and affect as many as 80% in this age group (Katz et al, 2018).There is no accepted outcome measure for sleep problems in children with ASD. The absence of a relevant, reliable and valid outcome measure is a barrier to rigorous testing of behavioral or pharmacological treatments targeting sleep in this population. Using a mixed method design, this multisite, transdisciplinary project will build a new parent rating for sleep disturbances and related impairments in children with ASD. The study is guided by methods described in Patient Reported Outcome Measures (www.Fda.Gov/Cder/Guidance, 2009). This monograph compels investigators to include the patient population in measure development. Given the age range of this study and likelihood of cognitive or language delays in children with ASD, we rely on parents as primary informants. We have an outstanding team of investigators and consultants with expertise in measure development and sleep problems in ASD. In Year 1, up to six focus groups with parents will explore the onset and behavioral manifestations of sleep problems in children with ASD. The focus group material will be reviewed and coded to generate a bank of items (Bearss et al. 2016). These items will be reviewed for clarity and reading level by parents and an expert panel. In Year 2, the bank of items (version 1 of ASD-Sleep Questionnaire; ASDSQ) will be placed on a secure website to collect parent-reported data on sleep disturbances and related impairments in 1200 children with ASD. Items will be scored 0-3 (none, mild, moderate or severe). Factor analysis and item response theory will be applied to establish the factor structure and prune the item pool toward the final version (Scahill et al. in press). In Year 3 and early Year 4, an in-person clinical assessment of 135 children with ASD (age 3-12 years) will be conducted to collect reliability and validity data on the final ASDSQ version. A subsample of children will be invited to return for test-retest on ASDSQ, 2 weeks and 4 weeks later. In Year 4, data from the clinical assessment will be used to evaluate convergent validity, divergent validity and test-retest reliability of the ASDSQ. Also in Year 3 and early Year 4, we will collect five consecutive nights of actigraphy data in a total of 75 children with ASD (age 3 to 12) to evaluate sleep efficiency (percentage of time sleeping divided by total time in bed with lights off). Actigraphy-measured sleep efficiency (ASE) will be used to conduct exploratory analyses comparing ASDSQ scores in children with impaired ASE values (poor sleepers) to those with acceptable ASE values (good sleepers) (Goldman et al. 2009; Moore et al. 2017). Receiver operating characteristic curves will be used to explore the sensitivity and specificity of SDSQ on ASE classifications.

项目摘要/摘要。该应用程序是根据 PAR-18-039 编写的，将推进睡眠问题的结果测量患有自闭症谱系障碍 (ASD) 的儿童（3-12 岁）。睡眠问题（例如睡眠障碍和患有自闭症谱系障碍（ASD）儿童的睡眠相关障碍）范围从轻度到重度，影响多达 80% 年龄组（Katz 等人，2018）。对于自闭症谱系障碍儿童的睡眠问题，目前尚无公认的结果衡量标准。缺乏相关、可靠和有效的结果测量是对行为或行为进行严格测试的障碍。针对该人群睡眠的药物治疗。使用混合方法设计，这个多站点，跨学科项目将为睡眠障碍和相关障碍建立新的家长评级患有自闭症谱系障碍的儿童。该研究以患者报告结果测量中描述的方法为指导（www.Fda.Gov/Cder/Guidance，2009 年）。该专着迫使研究人员将患者群体纳入其中在措施发展中。考虑到本研究的年龄范围以及认知或语言延迟的可能性对于患有自闭症谱系障碍 (ASD) 的儿童，我们依靠父母作为主要信息提供者。我们拥有一支由研究人员和顾问组成的优秀团队，他们在措施开发和 ASD 的睡眠问题。在第一年，最多六个与家长一起的焦点小组将探讨该病的发病和行为 ASD 儿童睡眠问题的表现。焦点小组材料将被审查并编码为生成一个项目银行（Bearss et al. 2016）。这些项目的清晰度和阅读水平将由家长和专家小组。在第 2 年，项目库（ASD 睡眠问卷第 1 版；ASDSQ）将放置在安全网站上，以收集家长报告的有关睡眠障碍和相关障碍的数据 1200 名患有自闭症谱系障碍 (ASD) 的儿童。项目评分为 0-3（无、轻度、中度或严重）。因素分析及项目将应用响应理论来建立因子结构并针对最终版本修剪项目池（Scahill 等人，待出版）。在第 3 年和第 4 年初，对 135 名自闭症谱系障碍 (ASD) 儿童进行了现场临床评估（3-12 岁）将收集最终 ASDSQ 版本的可靠性和有效性数据。一个儿童子样本将被邀请在 2 周和 4 周后返回进行 ASDSQ 重测。第四年，临床评估的数据将用于评估收敛效度、发散效度和重测 ASDSQ 的可靠性。同样在第三年和第四年初期，我们将连续五个晚上收集体动记录总共 75 名自闭症谱系障碍 (ASD) 儿童（3 至 12 岁）的数据用于评估睡眠效率（睡眠时间百分比）除以关灯在床上的总时间）。体动记录仪测量的睡眠效率（ASE）将用于进行探索性分析，比较 ASE 值受损（睡眠不佳者）儿童的 ASDSQ 分数与那些儿童的 ASDSQ 分数具有可接受的 ASE 值（良好睡眠）（Goldman 等人，2009 年；Moore 等人，2017 年）。接收器操作特征曲线将用于探讨 SDSQ 对 ASE 分类的敏感性和特异性。