Validation of the Social Communication CheckUp and Autism Risk Indicator in the First Year of Life

项目摘要 响应RFA-MH-19-120，本研究的目标是验证新的自动在线 筛选工具--社会沟通（SoCo）检查--结合了经过实验测试的筛选 项目的沟通延迟和自闭症谱系障碍（ASD）在3个月的年龄间隔。这个新的筛选 该工具是为在9、12、15、18、21和24个月大的健康儿童就诊时进行普遍筛查而设计的 交流迟缓和自闭症的症状SoCo CheckUp是我们的婴儿导航门户网站的一部分， 应用程序，其中包括SoCo成长图表-一个发展监测家庭回答 每2个月询问一次SoCo里程碑，以记录孩子在5个领域的成长，并探索 数以百计的视频剪辑，说明早期的里程碑与叙述的响应育儿。的家庭 积极的自闭症筛查有三个ASD专用工具的链接。我们将招募4,000名2个月大的婴儿， 他们的第一个良好的儿童访问之一，并邀请家庭到SoCo成长图表的发展监测。 然后，我们将邀请家庭进入门户网站，根据9个月时的父母报告进行SoCo检查， 在12、15、18、21和24个月时重复筛查。所有自闭症筛查呈阳性的儿童家庭 SoCo检查和相当数量的儿童与负屏幕将被邀请收集回家 使用ASD红旗系统观测（SORF）的观测筛选器的观测结果， 9-24个月的相同年龄。所有在SORF上ASD筛查呈阳性的儿童， 将邀请随机选择的SORF筛查阴性的儿童进行确证性诊断评价 在24个月的时候。我们预计至少有80名儿童根据先前的研究检测到1/50。 我们将讨论以下研究目标：目标1。研究SoCo Checkup切割的心理测量学特征- 关闭和复合诊断结果;目标2。研究SoCo监测和筛查的轨迹 来预测自闭症症状的严重程度;以及目标3。构建基于多参数的风险算法， 开发一种有效的、具有成本效益的移动的筛查应用程序，用于婴儿， 一般人口。本确认研究的预期结果将证明 在线监测和筛查系统从出生后第一年开始，将随时准备立即，快速， 可扩展的、可持续的部署。这些发现将通过为研究人员提供 一种招募社区样本的方法，允许在更年轻的年龄进行研究，这可能会加速 遗传学、生物医学和干预研究。利用创新技术、方便用户的工具和网络， 应用和实施科学方法增强了可持续性和可扩展性的潜力 这可能导致变革性的变化，以有效地筛查婴儿的沟通延迟， 自闭症和改善医疗服务。

PROJECT ABSTRACT In response to RFA-MH-19-120, the goal of this study is to validate the effectiveness of a new automated online screening tool—the Social Communication (SoCo) CheckUp—that incorporates empirically-tested screening items for communication delay and autism spectrum disorder (ASD) in 3-month age intervals. This new screening tool is designed for universal screening at well-child visits at 9, 12, 15, 18, 21, and 24 months of age to screen for communication delay and autism. The SoCo CheckUp is part of our Baby Navigator portal, a new mobile application that includes the SoCo Growth Charts—a developmental surveillance for families to answer questions about SoCo milestones every 2 months to chart their child’s growth in 5 domains and to explore hundreds of video clips illustrating early milestones with narration on responsive parenting. Families with a positive autism screen have links to three ASD-specific tools. We will recruit 4,000 infants by 2 months of age at one of their first well child visits and invite families to the SoCo Growth Charts for developmental surveillance. We will then invite families into the portal to screen with the SoCo Checkup based on parent report at 9 months, with repeat screenings at 12, 15, 18, 21, and 24 months. All families of children with a positive autism screen on the SoCo Checkup and a comparable number of children with a negative screen will be invited to collect home observations for an observational screener using the Systematic Observation of Red Flags of ASD (SORF) at the same ages from 9-24 months. All children with a positive ASD screen on the SORF and a comparable number of children randomly select with a negative SORF screen will be invited for a confirmatory diagnostic evaluation at 24 months. We anticipate confirming ASD for least 80 children based on previous research detecting 1/50. We will address the following research aims: Aim 1. Study psychometric features of the SoCo Checkup cut- off and composite to diagnostic outcome; Aim 2. Study the trajectories of the SoCo surveillance and screening to predict autism symptom severity; and Aim 3. Construct a risk algorithm based on multiple parameters to develop an efficient, cost-effective mobile screening application for use in infants that is readily deployable in the general population. The expected outcomes of this validation study will demonstrate the effectiveness of an online surveillance and screening system beginning in the first year of life that will be ready for immediate, rapid, scalable, and sustainable deployment across the US. Findings will advance science by providing researchers with a method for recruiting a community sample, allowing for research at younger ages, which could accelerate genetic, biomedical, and intervention research. The use of innovative technology, user-friendly tools and web- applications, and implementation science methodology enhances the potential for sustainability and scalability that can lead to transformative changes to efficiently and effectively screen infants for communication delay and autism and improve healthcare delivery.