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

• 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
• 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

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。 该应用程序是针对Par-18-039的响应，将提高有关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 与睡眠相关的障碍）在ASD的儿童中范围从轻度到重度，在此影响多达80％ 年龄组（Katz等，2018）。没有接受ASD儿童睡眠问题的结果措施。 没有相关，可靠和有效的结果指标是对行为或严格测试的障碍 针对该人群睡眠的药理治疗。使用混合方法设计，这个多站点 跨学科项目将建立一个新的父母评级，以解决睡眠障碍和相关障碍 有ASD的孩子。该研究以患者报道的结果指标中描述的方法指导 （www.fda.gov/cder/guidance，2009年）。该专着迫使调查人员包括患者人数 在衡量发展中。考虑到这项研究的年龄范围以及认知或语言延迟的可能性 患有ASD的孩子，我们依靠父母作为主要线人。 我们有一个杰出的调查员和顾问团队，具有衡量措施开发方面的专业知识， ASD的睡眠问题。在第一年，多达六个与父母的焦点小组将探索发作和行为 ASD儿童睡眠问题的表现。焦点小组材料将进行审查并编码为 生成一批物品（Bearss等，2016）。这些项目将通过 父母和专家小组。在第2年，项目银行（ASD-Sleep问卷的1版； Asdsq）将 被放置在安全的网站上，以收集有关睡眠障碍和相关障碍的父母报告的数据 在1200名ASD儿童中。项目将得分为0-3（无，轻度，中度或重度）。因素分析和项目 响应理论将应用于建立因子结构并修剪项目池朝向最终版本 （印刷中的Scahill等人）。在第3年和第4年，对135名ASD儿童进行面对面的临床评估 （3-12岁）将进行最终ASDSQ版本的可靠性和有效性数据。一个 2周零4周后，将邀请儿童子样本在Asdsq上返回重测。在第4年， 来自临床评估的数据将用于评估收敛有效性，发散有效性和重测 ASDSQ的可靠性。同样在第3年和第四年级，我们将连续五个晚上收集精力 共有75名ASD儿童（3至12岁）的数据评估睡眠效率（睡眠百分比 除了灯光下躺在床上的总时间）。 Actraphy测量的睡眠效率（ASE）将用于进行 比较ASE值受损（不良卧铺）儿童ASDSQ分数的探索性分析与那些 具有可接受的ASE值（良好的卧铺）（Goldman等，2009； Moore等，2017）。接收器操作 特征曲线将用于探索SDSQ对ASE分类的敏感性和特异性。