Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism

描述（由申请人提供）：这项拟议的R34 NIDCR规划和试点数据补助金的目标是收集信息，以支持以后的临床试验，该试验旨在研究专门为难以忍受牙科诊所口腔护理的儿童设计的牙科环境的有效性。在这个项目中，将研究两组儿童：自闭症谱系障碍（ASD）儿童和典型发育儿童，包括那些对感官刺激反应过度的儿童。通常，这些儿童在面对牙科就诊的体验方面时表现出焦虑和负面行为反应，例如暴露于明亮的荧光灯下，口腔内或周围的触摸，或各种口腔护理产品的质地和气味。在计划的R34补助金中，我们将试点测试一种感官适应性牙科环境（SADE），该环境具有很强的潜力，可以减少目标儿童群体的焦虑和行为问题。SADE干预包括调暗灯光、接触舒缓音乐和使用特殊背心等适应性调整，以提供镇静的深层压力感觉。如果我们的初步评估产生了有希望的结果，我们以后将在一个全面的随机临床试验中更全面地测试干预措施，该试验将得到U 01奖的支持。 R34补助金的具体目标是通过以下方式促进未来试验的能力：1.为SADE干预制定手册并评估干预的可行性。 2.收集有关干预措施有效性和潜在成本节约的初步数据。 3.对预期试验中使用的招募策略和评估组合进行初步测试。 4.为将来的试验开发文件和数据管理系统。 5.生成U 01合同的建议书，以进行计划的试验。 研究参与者将是40名6-12岁的不同种族的儿童，其中20名患有ASD，20名通常正在发展。每个孩子将接受两次牙齿清洁，间隔四个月：在标准的牙齿环境中进行牙齿清洁，在感官适应环境中进行牙齿清洁。对于每一组孩子（即，ASD和典型的发展），这两种情况将在其对焦虑和消极行为反应的影响进行比较，通过录像带编码，心理生理学指数和各种评定量表进行测量。 由于计划中的研究将有助于更安全，更有效，更便宜的治疗，它有可能为日益增长的ASD儿童人口以及具有牙科焦虑症的典型发育儿童彻底改变基于诊所的牙科护理。潜在的成本节约和对儿童舒适度的贡献是巨大的，因为超过四分之一的儿童可能受益于感官适应的牙科环境。

DESCRIPTION (provided by applicant): The goal of this proposed R34 NIDCR Planning and Pilot Data Grant is to collect information that will support a later clinical trial on the effectiveness of a specially adapted dental environment for children who have difficulty tolerating oral care in the dental clinic. Within this project, two groups of children will be studied: children with autism spectrum disorders (ASD) and typically developing children, including those who are over- reactive to sensory stimulation. Commonly, such children exhibit anxiety and negative behavioral reactions when confronted with experiential aspects of dental visits such as exposure to bright fluorescent lighting, touch in or around the mouth, or the texture and smell of various oral care products. In the planned R34 grant, we will pilot test a sensory adapted dental environment (SADE) that has a strong potential to reduce anxiety and behavioral problems among the targeted groups of children. The SADE intervention includes such adaptations as dimmed lighting, exposure to soothing music, and application of a special vest which provides deep pressure sensations that are calming. If our preliminary assessment produces promising results, we will later more comprehensively test the intervention in a full-scale randomized clinical trial, which will be supported by a U01 award. The specific aims of the R34 grant are to promote the ability to conduct the future trial by: 1. Developing a manual for the SADE intervention and assessing the intervention's feasibility. 2. Collecting preliminary data on the intervention's effectiveness and potential cost-savings. 3. Pilot testing the recruitment strategy and assessment battery that will be used in the anticipated trial. 4. Developing the system of documents and data management for the future trial. 5. Generating the proposal for the U01 award to conduct the planned trial. Research participants will be 40 ethnically diverse children aged 6-12 years, 20 with ASD and 20 who are typically developing. Each child will undergo two dental cleanings four months apart: dental cleaning in a standard dental environment and dental cleaning in the sensory adapted environment. For each group of children (i.e., ASD and typically developing), the two conditions will be compared in their effects on anxiety and negative behavioral reactions, as measured by videotape coding, psychophysiological indices, and various rating scales. Because the planned research will contribute to safer, more efficient, less costly treatment, it has the potential to revolutionize clinic-based dental care for the growing population of children with ASD, as well as for typically developing children who have dental anxieties. The potential cost savings and contribution to child comfort are dramatic, as potentially more than one-fourth of all children may benefit from a sensory adapted dental environment.