Detection of ASD at the 1st birthday as standard of care: The Get SET Early Model

描述（由申请人提供）：我们之前证明了我们的早期干预模型系统，该系统以使用CSBS在1年检查时筛查所有婴儿作为护理标准为中心，导致筛查的平均年龄为12个月，评估为14个月，治疗参与为18个月。我们的3阶段模型系统Get SET（S=Screen; E=Evaluate; T=Treat）Early在我们的第一次试验运行中筛选了> 10，000名1岁奥尔兹，检测了100多名ASD和其他发育迟缓的幼儿。我们将在两个主要城市（圣地亚哥和凤凰城）实施新版本的高效模型;洛杉矶、欧文和凤凰城将提供基线控制数据。在凤凰城，我们测试建立 在美国收入中位数最低、首次诊断年龄最大的城市之一，在AIM #1中，筛选和早期转诊阶段，我们将创建一个拥有100名成员的儿科医生网络。在圣地亚哥，我们将利用我们现有的儿科医生网络，并测试新的创新，如在12个月，18个月和24个月重复三重筛查，以确保没有幼儿被遗漏。将使用父（自我）和自动（转诊i-Pad应用程序）选项比较转诊评价的速度。我们将在限定的医疗组内跟踪每一个最终诊断为ASD的幼儿，以确定筛查工具的真实灵敏度和特异性以及我们的模型检测到的ASD幼儿的百分比。关于筛查习惯的匿名调查数据将提供给父母和儿科医生。AIM #2实现了早期评估和参考阶段。它的关键属性是ASD早期评估诊所，专门从事快速调度和评估每个推荐的筛查阳性幼儿。幼儿将在他们未能通过屏幕的年龄进入该计划（即，12、18或24个月），并将每年进行一次彻底的诊断评估和跟踪，直到他们满3岁。这个专业诊所是在我们的自闭症中心在圣地亚哥，并将在SARRC在凤凰城开发。将测试和比较自动化与可选的自我转诊治疗。AIM #3实现了早期治疗阶段。它的主要特点是一个经验性治疗提供者网络，以及创新地使用一个廉价和容易获得的基于网络的治疗跟踪系统来记录参与情况。治疗网络将在圣地亚哥和凤凰城建立。主要结局指标包括筛查和转诊的比率和年龄、评估和转诊以及治疗参与;跨年的可持续性;受试者的诊断、临床和人口统计学特征;每个阶段的专业和家长满意度。我们假设，提供具有明确截止评分的筛查工具和自动转诊评估和治疗指南，将导致凤凰城的平均诊断和治疗年龄从4-5岁大幅降低至1-2岁;圣地亚哥的平均诊断和治疗年龄也将为1-2岁，使其显著早于洛杉矶和欧文对照研究中心。

DESCRIPTION (provided by applicant): We previously demonstrated that our early intervention model system, which was centered on using the CSBS to screen all babies at the 1-year check-up as standard of care, resulted in a mean age of 12 months for screening, 14 months for evaluation, and 18 months for treatment participation. These are far younger ages than is common in the U.S. Our 3-stage model system, Get SET (S=Screen; E=Evaluate; T=Treat) Early, screened >10,000 1 year olds in our first trial run1 detecting over 100 ASD and other developmental delayed toddlers. We will build on this highly effective model by implementing a new version in two major cities: San Diego and Phoenix; Los Angeles, Irvine, and Phoenix will provide baseline control data. In Phoenix, we test the feasibility of establishing the Get SET Early model in a city with one of the lowest median incomes and oldest age of first diagnosis in America. In AIM #1, the Screen and Refer Early stage, we will create a Pediatrician Network with 100 members. In San Diego we will utilize our existing Pediatrician Network and test new innovations such as a repeat triple screen at 12, 18, and 24 months to ensure that no toddlers are missed. Speed of referral for evaluation will be compared and contrasted using parent (self) and automatic (referral i- Pad App) options. We will track every toddler with an eventual ASD diagnosis within circumscribed medical groups to determine the true sensitivity and specificity of the screening tool and the percentage of ASD toddlers detected by our model. Anonymous survey data regarding screening habits will be administered to parents and pediatricians. AIM #2 implements the Evaluate and Refer Early stage. Its key attribute is an ASD Early Evaluation Clinic that specializes in the rapid scheduling and evaluation of every referred screened positive toddler. Toddlers will enter the program at the age they fail the screen (i.e., 12, 18 or 24 months) and will be thoroughly diagnostically evaluated and tracked once per year until they turn 3 years. This specialty Clinic is at our Autism Center in San Diego and will be developed at SARRC in Phoenix. Automated versus optional self-referral for treatment will be tested and compared. AIM #3 implements the Treat Early stage. Its key attributes are a network of providers of empirically based treatment and the innovative use of an inexpensive and readily available web-based treatment tracking system to document engagement. Treatment Networks will be created in San Diego and Phoenix. Primary outcome measures include rates and ages of screening and referral, evaluation and referral, and treatment engagement; sustainability across years; diagnostic, clinical and demographic characteristics of subjects; professional and parent satisfaction at each stage. We hypothesize that providing screening tools with clear cut-off scores and guidelines for automatic referral for evaluation and treatment, will result in dramatically lowering mean age of diagnosis and treatment in Phoenix from 4-5 years down to 1-2 years; San Diego will likewise have mean ages of 1-2 years for diagnosis and treatment making them significantly earlier than Los Angeles and Irvine control sites.