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化在线的有效性 筛查工具-社交(SoCo)检查-结合了经验证的筛查 沟通障碍和自闭症谱系障碍(ASD)的项目在3个月的年龄间隔。这次新的放映 该工具专为9、12、15、18、21和24个月大的健康儿童进行全面筛查而设计 治疗沟通延迟和自闭症。SoCo检查是我们的Baby Navigator门户网站的一部分，这是一款新的移动设备 包括SoCo Growth图表的应用程序-家庭需要回答的发展监测 关于SOCO里程碑的问题每2个月绘制他们孩子在5个领域的成长图表并进行探索 数百个视频剪辑说明了早期的里程碑，并讲述了响应性的育儿方式。家庭有一个 阳性自闭症筛查有三个ASD专用工具的链接。我们将在2个月大的时候招募4000名婴儿 这是他们第一次探访健康儿童，并邀请家庭参加SoCo Growth Charts，以进行发育监测。 然后我们将邀请家庭进入门户网站，在9个月时使用基于家长报告的SoCo Checkup进行筛查， 12个月、15个月、18个月、21个月和24个月进行重复筛查。所有自闭症筛查呈阳性的儿童家庭 Soco Checkup和同等数量的阴性屏幕儿童将被邀请到家领取 利用ASD红旗系统观测(SORF)的观测筛选器 年龄从9个月到24个月不等。所有在SORF上ASD筛查呈阳性且有类似人数的儿童 随机选择的SORF筛查阴性的儿童将被邀请进行验证性诊断评估 在24个月的时候。我们预计至少有80名儿童可以在先前检测到1/50的ASD的研究基础上确诊为ASD。 我们将致力于以下研究目标：目标1.研究SOCO体检切割的心理测量学特征- 关闭并合成诊断结果；目标2.研究SOCO监测和筛查的轨迹 预测自闭症症状严重程度；以及目标3.构建基于多参数的风险算法 开发用于婴儿的高效、经济高效的移动筛查应用程序，该应用程序可随时部署在 普通人口。这项验证研究的预期结果将证明 从出生第一年开始的在线监控和筛查系统，将立即、快速、 在全美范围内可扩展、可持续的部署。这些发现将通过为研究人员提供 通过一种招募社区样本的方法，允许在更年轻的时候进行研究，这可能会加快 遗传学、生物医学和干预研究。使用创新的技术、用户友好的工具和网络- 应用程序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，以高效和有效地筛查婴儿的沟通延迟和 自闭症和改善医疗保健服务。

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.