Treatment of sleep disturbances in school-age children with Down syndrome

学龄唐氏综合症儿童睡眠障碍的治疗

• 批准号: 8966919
• 负责人: Anna J. Esbensen
• 金额: $ 23.4万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-06 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8966919
• 关键词: Address; Adopted; Affect; Age; Attention; Autistic Disorder; Behavior Control; Behavior Therapy; Behavioral; Caregivers; Caring; Child; Cognitive; Controlled Clinical Trials; Data; Development; Developmental Disabilities; Down Syndrome; Education; Effectiveness; Evidence based treatment; Executive Dysfunction; Family; Generations; Genetic; Goals; Health Personnel; Impaired cognition; Impairment; Individual; Intellectual functioning disability; Intervention; Learning; Life; Link; Maintenance; Measures; Medical; Mental Depression; Monitor; Moods; Obstructive Sleep Apnea; Outcome; Outcome Measure; Parenting Education; Parents; Phenotype; Population; Positioning Attribute; Problem behavior; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Research; Research Priority; Research Support; School-Age Population; Services; Site; Sleep; Sleep Disorders; Sleep disturbances; Stress; Techniques; Testing; Time; United States National Institutes of Health; Visual; Vulnerable Populations; Work; actigraphy; autism spectrum disorder; base; behavioral clinical trial; behavioral outcome; clinical decision-making; cognitive process; cognitive testing; daily functioning; diaries; effective therapy; efficacy testing; efficacy trial; evidence base; executive function; expectation; experience; functional outcomes; improved; inattention; informant; member; post intervention; primary outcome; programs; public health relevance; sleep position; standard of care; teacher; therapy design

 DESCRIPTION (provided by applicant): There is a fundamental gap in the availability of evidence-based treatments for disruptive sleep problems among children with Down syndrome (DS). Lack of such treatments represents an important problem because 52-69% of these individuals experience behaviorally-based difficulties with sleep initiation, sleep maintenance and early wakening's. These problems reduce the amount and quality of sleep, and have been linked to daytime inattention and behavior problems and increased parental burden. Without evidence-based behavioral interventions, treatment of disruptive sleep problems will remain suboptimal. Despite promising findings, the evidence base for behavioral sleep treatment (BST) in DS is limited. Controlled clinical trials are the clear next step towards empirically-based treatment for behavioral sleep problems in children with DS. BST have been successfully used to treat behavioral sleep problems among children with autism spectrum disorder. Following the same path, the current study adopts these BST techniques and adapts them to fit the most common DS phenotype. The overall objective of this application is to test the efficacy of a manualized BST using a randomized control trial with children with DS. Our rationale for working with this population is that disruptive sleep problems are a clinically important and highly prevalent condition among these children, and that the DS behavioral phenotype will require adaptations to current BST. We propose three specific aims: 1) To test the efficacy of manualized BST for improving the sleep of children with DS. 2) To test the impact of the BST on improving the daytime functioning of children with DS. 3) To test whether the BST, which focuses only on the child's sleep, improves caregivers' sleep and stress. To achieve these aims, a randomized control trial will be conducted with 80 children ages 6-17 years with DS experiencing behavioral sleep problems comparing a 5- session parent education BST to an enhanced standard of care parent education control program. Objective and informant-report (both parent and teacher) will be collected on the primary outcome measures of sleep duration, sleep quality, inhibitory control, behavior problems, parental sleep duration, and parental stress. This will be the first randomized clinical trial of a BST developed for this vulnerable population f children. Our research team is uniquely positioned to conduct this work, combining expertise in DS, clinical trials, BST of children with developmental disabilities, and assessment of sleep and related functional outcomes. We anticipate that this small-scale efficacy trial will provide criticl guidance for large-scale, multi-site efficacy and effectiveness work. Our goals are in line with NICHD's research priority to support treatment among individuals with intellectual and developmental disabilities. If the intervention is as efficacious as our preliminary evidence and work with other populations suggest, this would provide a clear evidence base for clinical decision-making to improve the outcomes for the approximately 42,000-58,000 children with DS and disruptive sleep nationwide.

 描述（由申请人提供）：在唐氏综合征（DS）儿童的破坏性睡眠问题的循证治疗方面存在根本性差距。缺乏这种治疗是一个重要的问题，因为这些人中有52-69%的人在睡眠开始、睡眠维持和早醒方面经历基于行为的困难。这些问题降低了睡眠的数量和质量，并与白天注意力不集中和行为问题以及增加父母负担有关。如果没有基于证据的行为干预，对破坏性睡眠问题的治疗将仍然是次优的。尽管研究结果令人鼓舞，但DS的行为睡眠治疗（BST）的证据基础有限。对照临床试验是明确的下一步，以药物为基础的治疗行为睡眠问题的儿童DS。BST已成功用于治疗自闭症谱系障碍儿童的行为睡眠问题。遵循相同的路径，目前的研究采用这些BST技术，并调整它们以适应最常见的DS表型。本申请的总体目标是使用DS儿童的随机对照试验来测试手动BST的疗效。我们对这一人群进行研究的理由是，破坏性睡眠问题是这些儿童中临床上重要且高度流行的疾病，并且DS行为表型需要适应当前的BST。我们提出了三个具体目标：1）测试手动BST改善DS儿童睡眠的功效。2)测试BST对改善DS儿童日间功能的影响。3)测试只关注孩子睡眠的BST是否改善了照顾者的睡眠和压力。为了实现这些目标，将在80名6-17岁患有DS的儿童中进行一项随机对照试验，将5次家长教育BST与增强的护理标准家长教育对照计划进行比较。将收集关于睡眠持续时间、睡眠质量、抑制控制、行为问题、父母睡眠持续时间和父母压力等主要结局指标的客观和信息报告（父母和教师）。 这将是第一个随机临床试验的BST开发的这一弱势群体的儿童。我们的研究团队在开展这项工作方面具有独特的优势，结合了DS，临床试验，发育障碍儿童BST以及睡眠和相关功能结果评估方面的专业知识。我们预计，这项小规模的疗效试验将为大规模、多中心的疗效和有效性工作提供关键性指导。我们的目标与NICHD的研究重点一致，以支持智力和发育障碍患者的治疗。如果干预措施像我们的初步证据和与其他人群的合作所表明的那样有效，这将为临床决策提供明确的证据基础，以改善全国约42，000 - 58，000名患有DS和睡眠中断的儿童的结果。