Ready, Set, Snooz! A web-delivered, prescriptive intervention for pediatric sleep

描述(申请人提供)：儿童睡眠不足被国会和卫生与公众服务部确认为临床科学调查的高度优先目标，因为它与持久的身体、情感和行为问题有关，包括超重/肥胖、注意力不集中、多动、学习问题、行为问题、药物使用、焦虑和抑郁。以行为为基础的干预措施已被证明对儿童睡眠困难和障碍有效，但它们仍未得到充分利用，尽管FDA没有批准为这一群体提供药物，但仍有大约80%的儿童[37]得到了睡眠药物的处方。鉴于美国高达70%的10岁及以下儿童每周都会出现几次睡眠问题[1]，研究人员已经证明行为睡眠干预是有效的，我们必须通过为儿童及其照顾者开发更容易获得、负担得起且更具参与性的干预措施来解决这一利用不足的问题。基于软件的干预措施提供了一种改进的方法，可以将经验支持的睡眠治疗直接传播给家庭，就像他们有其他儿科疾病，如糖尿病、哮喘和社交焦虑一样。然而，鉴于现有的大量基于网络的干预措施，仅靠软件并不能解决与利用不足有关的问题。开发和纳入更具互动性、体验性和基于游戏的组件，如虚拟现实(VR)和代币经济，将导致更大的参与度和使用动机，最终导致更好的治疗结果。这种技术范式转向更具体验性、基于情景和互动的内容，在提供基于虚拟技能的练习、实时反馈、娱乐游戏的机会以及更吸引人的心理教育形式方面，比传统干预具有明显的优势。利用VR技术作为互联网提供的儿童行为治疗计划的一部分，是确保获得循证护理和优化结果的一种新方法。这项干预将是第一个针对睡眠问题儿童利用基于网络的平台的项目，该平台具有吸引力、教育性、基于技能和易于访问的特点。这一阶段的SBIR将建立一种名为“Ready，Set，Snooz”的干预措施，这是一种用户友好、交互和负担得起的基于网络的治疗计划，具有在第二阶段之后广泛传播、适应不同疾病并实现商业化的巨大潜力。这种基于网络的干预措施将包括三个临床组成部分：1)睡眠跟踪，2)教育/技能发展，3)虚拟睡眠培训。所有信息都将以已学/已练的技能为基础，按顺序列出。此外，嵌入式虚拟游戏将向所有用户提供，他们可以将干预期间获得的虚拟令牌交换为虚拟游戏内容并访问新的游戏关卡，这是当今许多智能设备游戏中常见的一种方法。我们将根据知识、动机/自我效能以及实际睡眠模式和行为的变化来评估治疗方案的可行性、可信度和可接受性，以及初步的临床疗效。我们的干预，Ready，Set，Snooz“，将代表着第一个针对有睡眠困难的学龄儿童的指令性、参与性和互动式网络干预，需要儿童和家长的积极参与。我们相信，基于其新颖性、美观性、易用性以及医疗保健专业人员和家庭的接受/推广，这种干预措施将超过现有的以儿童为中心的软件程序方法。如果成功，我们设想VR项目将成为互动VR干预的模板，适用于患有其他需要自我管理的疾病的儿童，如哮喘、糖尿病和食物过敏。在计算机、智能手机和平板电脑技术日益广泛获得和日常使用的时代，商业机会的前景意义重大。

DESCRIPTION (provided by applicant): Insufficient sleep in children is recognized by Congress and the Department of Health and Human Services as a high priority target for clinical scientific investigation given its consist link with enduring physical, emotional and behavioral problems, including overweight/obesity, inattention, hyperactivity, learning problems, conduct problems, substance use, anxiety, and depression. Behaviorally-based interventions have been proven efficacious for pediatric sleep difficulties and disorders, but they remain under utilized, with approximately 80% [37] of children being prescribed sleep medication despite no FDA approved medications for this population. Given that up to 70% of children in the U.S. age 10 and under experience a sleep problem several times per week [1], and researchers have shown behavioral sleep interventions to be efficacious, we must address this under-utilization by developing more accessible, affordable, and engaging interventions for children and their caregivers. Software-based interventions offer an improved means of disseminating empirically-supported treatments for sleep directly to families, just as they have other pediatric conditions such as diabetes, asthma, and social anxiety. However, in light of the myriad of web-based interventions currently available, software alone does not address issues associated with under-utilization. Development and incorporation of more interactive, experiential, and game-based components such as virtual reality (VR) and token economies, will lead to greater engagement and motivation for use, ultimately resulting in better treatment outcomes. This technological paradigm shift to more experientially, context-based, and interactive content offers distinct advantages over traditional interventions in its ability to provide virtual skills-based practice with real-time feedback, opportunities for entertaining gaming, and more engaging formats of psychoeducation. Utilization of VR technology as part of an internet-delivered behavioral treatment program for children is a novel approach to ensuring access to evidence-based care and optimizing outcomes. This intervention will be the first program for children with sleep problems to leverage a web-based platform that is engaging, educational, skills-based, and easily accessible. This Phase I SBIR will build an intervention called Ready, Set, Snooz", a user-friendly, interactive, and affordable web-based treatment program with a high potential for broad dissemination, adaptation and commercialization across different disease conditions beyond Phase II. This web-based intervention will consist of three Clinical Components: 1) Sleep Tracking, 2) Education/Skill Development, and 3) Virtual Sleep Training. All information will be presented in a sequenced format as to build upon skills already learned/practiced. Additionally, an imbedded virtual game will be available to all users who can exchange virtual tokens earned during the intervention for virtual game content and access to new game levels, a methodology common among many smart device games today. We will evaluate the feasibility, credibility, and acceptability of the treatment program, as well as initial clinical efficacy basedon knowledge, motivation/self- efficacy, and changes in actual sleep patterns and behaviors. Our intervention, Ready, Set, Snooz", will represent the first prescriptive, engaging, and interactive web-based intervention for school-aged children with sleep difficulties, requiring active participation by both the child and parent. We believe this intervention will surpass existing approaches for child-focused software programs based on its novelty, aesthetics, ease of use, and acceptance/promotion by health care professionals and families. If successful, we envision that the VR program will serve as a template for interactive VR interventions for children with other conditions requiring self-management, such as asthma, diabetes, and food allergies. The promise of commercial opportunity is significant in an era in which there is increasingly widespread access to and everyday use of computers, smart phones, and tablet technologies.