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

生命第一年社交沟通检查和自闭症风险指标的验证

• 批准号: 10020440
• 负责人: AMY M WETHERBY
• 金额: $ 61.15万
• 依托单位: FLORIDA STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-18 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10020440
• 关键词: Address; Age; Age-Months; Algorithms; Biomedical Research; Centers for Disease Control and Prevention (U.S.); Child; Child Care; Child Rearing; Clinical; Clip; Communication; Communication impairment; Communities; Data; Development; Diagnosis; Diagnostic; Early Intervention; Effectiveness; Ethnic Origin; Evaluation; Factor Analysis; Family; Florida; General Population; Genetic Research; Goals; Growth; Guidelines; Health education; Home environment; Infant; Intercept; Intervention; Intervention Studies; Language; Lead; Learning; Life; Link; Longitudinal Studies; Measures; Methodology; Methods; Narration; Outcome; Parents; Primary Care Physician; Primary Health Care; Psychometrics; Race; Reporting; Research; Research Personnel; Research Project Grants; Risk; Sampling; Science; Screening procedure; Sensitivity and Specificity; Severities; Social Discrimination; Symptoms; System; Testing; Time; Toddler; Validation; Visit; autism spectrum disorder; base; checkup examination; community setting; cost effective; design; early screening; effective intervention; effectiveness validation; health care delivery; health care settings; implementation science; improved; innovative technologies; kindergarten; mobile application; recruit; response; rural healthcare; screening; skills; social communication; socioeconomics; theories; tool; user-friendly; validation studies; web app

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.

项目摘要 为了回应 RFA-MH-19-120，本研究的目标是验证新的自动化在线系统的有效性 筛查工具——社交传播 (SoCo) CheckUp——包含经过实证检验的筛查 以 3 个月为间隔的沟通延迟和自闭症谱系障碍 (ASD) 项目。此次新放映 该工具专为 9、12、15、18、21 和 24 个月大的儿童就诊时进行普遍筛查而设计 用于沟通延迟和自闭症。 SoCo CheckUp 是我们的 Baby Navigator 门户的一部分，这是一个新的移动设备 包含 SoCo 生长图表的应用程序 - 供家庭回答的发育监测 每 2 个月询问一次有关 SoCo 里程碑的问题，以绘制孩子在 5 个领域的成长情况并进行探索 数百个视频剪辑展示了早期里程碑，并附有响应式育儿的旁白。家庭有 积极的自闭症筛查包含三个 ASD 特定工具的链接。我们将招募 4,000 名 2 个月大的婴儿 这是他们第一次探访儿童健康状况，并邀请家人参加 SoCo 生长图表进行发育监测。 然后，我们将邀请家庭进入门户网站，根据 9 个月时的家长报告进行 SoC 检查， 在 12、15、18、21 和 24 个月时重复筛查。所有自闭症筛查结果呈阳性儿童的家庭 SoCo 检查和相当数量的筛查呈阴性的儿童将被邀请接回家 使用 ASD 红旗系统观察 (SORF) 进行观察筛查的观察 9-24个月的年龄相同。所有在 SORF 上 ASD 筛查呈阳性的儿童以及相当数量的儿童 随机选择 SORF 筛查阴性的儿童将被邀请进行确认性诊断评估 24 个月大时。根据之前检测到 1/50 的研究，我们预计至少有 80 名儿童患有自闭症谱系障碍 (ASD)。 我们将实现以下研究目标： 目标 1. 研究 SoC Checkup 的心理测量特征 关闭并综合诊断结果；目标 2. 研究 SoC 监视和筛查的轨迹 预测自闭症症状的严重程度；目标 3. 构建基于多个参数的风险算法 开发一种高效、经济高效的婴儿移动筛查应用程序，可轻松部署在 一般人群。该验证研究的预期结果将证明该方法的有效性 从生命的第一年开始的在线监测和筛查系统将准备好立即、快速、 在美国各地进行可扩展且可持续的部署。研究结果将通过为研究人员提供信息来推动科学发展 一种招募社区样本的方法，允许在更年轻的年龄进行研究，这可以加速 遗传、生物医学和干预研究。使用创新技术、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 这可以带来变革性的改变，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。