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

 描述(由申请人提供)：唐氏综合症(DS)儿童扰乱性睡眠问题的循证治疗存在根本差距。缺乏这样的治疗是一个重要的问题，因为这些人中有52%-69%的人在入睡、睡眠维持和早醒方面经历了基于行为的困难。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、行为问题和增加的父母负担有关。如果没有循证的行为干预，破坏性睡眠问题的治疗将仍然是次优的。尽管有很有希望的发现，行为睡眠疗法(BST)在DS中的证据基础是有限的。对照临床试验是以经验为基础治疗DS儿童行为睡眠问题的明确下一步。BST已成功用于治疗自闭症谱系障碍儿童的行为睡眠问题。沿着同样的道路，本研究采用了这些BST技术，并对它们进行了调整，以适应最常见的DS表型。该应用程序的总体目标是通过对患有DS的儿童进行随机对照试验来测试手动BST的有效性。我们与这些人群合作的理由是，扰乱性睡眠问题在这些儿童中是一种临床上重要且高度流行的疾病，DS行为表型将需要适应当前的BST。我们提出了三个具体目标：1)测试手动BST对改善DS儿童睡眠的有效性。2)探讨BST对改善DS患儿日间功能的影响。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，将对80名6-17岁患有DS行为睡眠问题的儿童进行随机对照试验，比较5次家长教育BST和增强照顾标准家长教育控制计划。目的和提供信息的报告(包括家长和教师)将收集关于睡眠时间、睡眠质量、抑制控制、行为问题、父母睡眠时间和父母压力等主要结果测量的报告。 这将是为这一脆弱的儿童群体开发的BST的第一次随机临床试验。我们的研究团队在开展这项工作方面具有得天独厚的优势，结合了DS、临床试验、发育障碍儿童的BST以及睡眠和相关功能结果评估方面的专业知识。我们期待这次小规模的疗效试验将为大规模、多点的疗效和有效性工作提供关键的指导。我们的目标与NICHD的研究重点一致，即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对其他人群的研究表明的那样有效，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和睡眠障碍的儿童的结果。

 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.