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

描述(申请人提供)：我们之前证明了我们的早期干预模式系统，以1岁体检时使用CSBS对所有婴儿进行筛查为标准，导致筛查的平均年龄为12个月，评估的平均年龄为14个月，参与治疗的平均年龄为18个月。这些儿童的年龄比美国的普遍水平要小得多。我们的三阶段模型系统，在我们的第一次试验中，对10,000名1岁儿童进行了早期设定(S=筛查；E=评估；T=治疗)，检测到了100多名自闭症和其他发育迟缓的幼儿。我们将在这一高度有效的模型的基础上，在两个主要城市实施新版本：圣地亚哥和凤凰城；洛杉矶、欧文和凤凰城将提供基线控制数据。在凤凰城，我们测试了建立 GET在美国收入中位数最低、首次确诊年龄最大的城市之一设定了早期模式。在AIM#1的前期筛选和咨询阶段，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，测试新的创新，例如在12个月、18个月和24个月时重复进行三重筛查，以确保没有人错过幼儿。评估的推荐速度将使用家长(自我)和自动(推荐I-Pad App)选项进行比较和对比。我们将在限定的医疗小组中跟踪每个最终被诊断为ASD的幼儿，以确定筛查工具的真实敏感性和特异性，以及我们的模型检测到的ASD幼儿的百分比。有关筛查习惯的匿名调查数据将管理给父母和儿科医生。目的#2实施评估和推荐的早期阶段。它的关键属性是ASD早期评估诊所，专门为每个推荐的筛查阳性幼儿进行快速计划和评估。学步儿童将在未通过筛查的年龄(即12、18或24个月)进入该计划，并将接受彻底的诊断评估和每年一次的跟踪，直到他们年满3岁。这个专科诊所在我们圣地亚哥的自闭症中心，并将在凤凰城的SARRC开发。将测试和比较自动和可选的自我转诊进行治疗。目的3实施早期治疗。它的主要特点是建立了一个经验型治疗提供者网络，并创新地使用了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。主要结果指标包括筛查和转诊、评估和转诊的比率和年龄，以及治疗参与度；多年来的可持续性；受试者的诊断、临床和人口学特征；每个阶段的专业和家长满意度。我们假设，为评估和治疗提供明确的截止分数和自动转诊指南的筛查工具，将导致凤凰城的平均诊断和治疗年龄从4-5岁降至1-2岁；圣地亚哥的平均诊断和治疗年龄也将同样为1-2岁，使其明显早于洛杉矶和欧文的控制点。

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.