CLINICAL PHENOTYPE: RECRUITMENT AND ASSESMENT CORE

临床表型：招募和评估核心

• 批准号: 8117637
• 负责人: Karen L Pierce
• 金额: $ 36.2万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-01 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8117637
• 关键词: 3 year old; Age; Age-Months; Area; Authorization documentation; Autistic Disorder; Behavior; Behavioral; Biological; Biological Factors; Blood specimen; Brain; Child; Childhood; Clinical; Clinical Research; Clinical assessments; Cognitive; Collaborations; Collection; DSM-IV; Data; Data Analyses; Development; Developmental Delay Disorders; Diagnosis; Diagnostic; Disease; Early identification; Ensure; Ethnic Origin; Evaluation; Evaluation Studies; Family; Functional Magnetic Resonance Imaging; Funding; Gender; Genetic; Genetic Research; Goals; Grant; Grouping; Guanine Nucleotide Dissociation Inhibitors; Guidelines; Health Insurance Portability and Accountability Act; Human Resources; Image; Infant; Informed Consent; Judgment; Language; Letters; Magnetic Resonance Imaging; Measures; Methods; Mission; Mothers; Neurologic; Neurologic Examination; Neurologist; Nurse Practitioners; Participant; Population; Prospective Studies; Psychologist; Psychometrics; Quality Control; Recruitment Activity; Research; Research Personnel; Research Subjects; Resources; Risk; Scanning; Schedule; Screening procedure; Services; Siblings; Side; Staging; System; Time; Work; autism spectrum disorder; base; blind; checkup examination; clinical phenotype; cost; design; developmental disease; disorder risk; experience; high risk; innovation; member; pediatrician; programs; prospective; research study; social; social communication

Our Autism Center of Excellence (ACE) aims to discover the mechanisms related to early brain overgrowth in autism and to define specific behavioral and biological factors associated with infants at-risk for the disorder. These goals can only be achieved if autism is studied prospectively. Currently, the only prospective strategy in use is the baby-sibling design. Unfortunately, the baby-sib approach is weighed down by heavy research costs, long time frames to identify and follow cases, and only represents autism as it occurs in multiplex families. The Clinical Phenotype: Recruitment and Assessment Core (CPRAC) will implement a different strategy, called the 1-Year Well-Baby Check-Up Approach, to identify and study infants at risk for an ASD prospectively. As shown in the preliminary results section, this approach has the potential to identify at-risk cases quickly, and for a fraction of the cost of baby-sib research. Importantly, this unbiased approach will identify ASD cases from singleton and multiplex families alike, and as such may more realistically represent the population of autism. This method will allow infants at-risk for an ASD as well as those at-risk for a developmental disorder (DD) to participate in MRI (Project 1), fMRI (Project 2) and genetic research studies (Projects 3 and 4) beginning at 12-months in age. The CPRAC will also recruit, using the same approach, age, gender and ethnicity-matched typical controls. Thus, the CPRAC will recruit a total of 3 study groups: at-risk ASD, at-risk DD, and typical. The CPRAC will also thoroughly characterize each study infant using standardized clinical and experimental measures in the general areas of social, cognitive, language, and exploration behavior. Infants will also receive a thorough physical and neurological examination and have blood samples collected through CPRAC services. The CPRAC will follow infants longitudinally and collect selected study data every 6 months until each participant turns three years old. CPRAC investigators will implement quality control of assessments and adhere to all research subject protection guidelines including HIPAA. In summary, the CPRAC will be responsible for: 1) identification and recruitment of 12-month old infants; 2) diagnostic and psychometric evaluations of study infants every 6 months 3) coordination of each infant's participation in Projects 1-4; 4) final diagnoses when each participant turns three. The CPRAC will also be responsible for informed consent and ensuring compliance with current clinical and research standards and guidelines, including HIPAA. The CPRAC will also work closely with investigators on each of the projects, as well as the other Cores.

我们的自闭症卓越中心（ACE）旨在发现与早期大脑相关的机制， 自闭症的过度生长，并确定与风险婴儿相关的特定行为和生物因素 治疗这种疾病只有对自闭症进行前瞻性研究，这些目标才能实现。目前，唯一 使用的前瞻性策略是婴儿-同胞设计。不幸的是，婴儿-同胞的方法是权衡 由于高昂的研究成本，识别和跟踪病例的时间较长， 它发生在多个家庭中。 临床表型：招募和评估核心（CPRAC）将实施不同的策略， 一项名为“1年健康婴儿检查法”的研究，旨在识别和研究有ASD风险的婴儿。 前瞻性地。如初步结果部分所示，这种方法有可能识别风险 而且花费只是婴儿同胞研究的一小部分。重要的是，这种无偏见的方法将 从单胎和多胎家庭中识别ASD病例，因此可能更现实地代表 自闭症的人口。这种方法将允许有ASD风险的婴儿以及有ASD风险的婴儿， 发育障碍（DD）参与MRI（项目1）、fMRI（项目2）和遗传研究 （项目3和4）从12个月龄开始。CPRAC还将使用相同的方法招募， 年龄、性别和种族匹配的典型对照。因此，CPRAC将招募总共3个研究组： 高危ASD、高危DD和典型。 CPRAC还将使用标准化临床和 在社会，认知，语言和探索行为的一般领域的实验措施。 婴儿还将接受全面的身体和神经系统检查，并收集血液样本 通过CPRAC服务。CPRAC将对婴儿进行纵向随访，并收集选定的研究数据， 6个月，直到每个参与者满3岁。 CPRAC研究者将实施评估的质量控制，并遵守所有研究主题 包括HIPAA在内的保护指南。 总之，CPRAC将负责：1）识别和招募12个月大的婴儿; 2)每6个月对研究婴儿进行一次诊断和心理测量评估; 3）每个婴儿的协调性 参与项目1-4; 4）每个参与者满三岁时的最终诊断。CPRAC还将 负责知情同意并确保符合当前的临床和研究标准， 包括健康保险责任法案。CPRAC还将与每个项目的调查人员密切合作， 和其他核心一样