Recruitment and Clinical Assessment Core

招募和临床评估核心

• 批准号: 10531472
• 负责人: JOACHIM F HALLMAYER
• 金额: $ 31.35万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-06 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10531472
• 关键词: ASD patient; Affect; Attention; Autism diagnostic; Behavior; Behavior assessment; Behavioral; Behavioral Symptoms; Brain; Caregivers; Child; Child Behavior Checklist; Clinical; Clinical assessments; Cognitive; Consensus; Consent; Data; Data Analytics; Development; Diagnostic; Dimensions; Disease; Enrollment; Ensure; Epidemiology; Family; Family history of; Foundations; Functional disorder; Genes; Genetic study; Goals; Interview; Learning; Link; Medical; Medical History; Mission; Mutation; Neurobehavioral Manifestations; Neuronal Plasticity; Neurons; Parents; Participant; Pathogenesis; Pathway interactions; Physical Examination; Procedures; Questionnaires; Resources; Role; Sampling; Schedule; Sensory; Services; Sleep; Sleep disturbances; Sleeplessness; Structure; Symptoms; Synapses; Synaptic plasticity; Training; adolescent with autism spectrum disorder; animal data; autism diagnostic observation schedule; autism spectrum disorder; base; clinical diagnostics; cognitive testing; cohort; common symptom; comorbidity; data exchange; data management; experience; gene function; non rapid eye movement; participant enrollment; psychosocial; recruit; repetitive behavior; sleep abnormalities; sleep behavior; sleep onset; sleep quantity; social; social communication; success

The Recruitment and Clinical Assessment Core (RAC) will be responsible for a) enrollment of participants; b) review and/or conduct of diagnostic, clinical, cognitive and behavioral assessments; c) systematic sequential scheduling of participants across Project 1 and 2; and d) data scoring, entry, tracking, QC procedures and data transfer procedures to the Data Management and Analytic Core (DMAC). The RAC interacts with the Administrative Core (AC) and the DMAC at all levels. The Objectives of the RAC are: Objective 1. Enrollment of 180 ASD patients and 100 controls for participation in the ACE, to ensure a core sample of 150 ASD and 75 control participants in Project 1, and 78 ASD participants in Project 2 (Project 2 will not enroll healthy controls). The RAC will be responsible for contacting, enrollment, and consenting of all participants; scheduling and clinical review of the physical examination and the cognitive and behavioral assessments; and the scheduling of the participants for assessments in Project 1 and 2. Objective 2. Characterization and Clinical, Medical, Cognitive and Behavioral Assessment of participation in the ACE. The RAC will a) obtain a thorough medical history of the participant and the family; b) conduct a physical examination; c) obtain questionnaires from parents/caregivers of all participants (ASD and Control), including: ACE Subject Medical History; ACE Family Medical History; Sleep Habits Questionnaire Child; Sleep Habits Questionnaire Parents; Social Responsiveness Scale (SRS-2): Stanford Social Dimension Scale (SSDS); Repetitive Behavior Scale, Revised (RBS-R); Dimensional Assessment of Restricted/Repetitive Behaviors (DARB); Sensory Profile Questionnaire (SPQ-2); Child Behavior Checklist (CBCL); Aberrant Behavior Checklist (ABC); and Vineland Adaptive Behavioral Scale, Third Edition (VABS-3); d) administer the Stanford Binet 5 or the Mullen Scales of Early Learning as appropriate, and the NEPSY-2 Affect Recognition subtest to all participants (ASD and controls); e) administer the Autism Diagnostic Interview-Revised (ADI-R) to parents of the ASD participants; f) administer the Autism Diagnostic Observation Schedule (ADOS-2) to the ASD subjects; and g) obtain the Social Communication Questionnaire (SCQ) from parents/caregivers of control participants. Objective 3. Acquisition, data entry, management and transfer to the Data Management and Analytic Core (DMAC) of all RAC demographic, medical, diagnostic, clinical, behavioral and cognitive data.

招募和临床评估中心（RAC）将负责a）招募 参与者; B）审查和/或进行诊断、临床、认知和行为评估; c） 在项目1和2中系统地顺序安排参与者;以及d）数据评分、录入、跟踪， QC程序和向数据管理和分析中心（DMAC）的数据传输程序。的RAC 与各级行政核心（AC）和DMAC互动。RAC的目标是： 目的1.招募180名ASD患者和100名对照参与ACE，以确保 项目1中的150名ASD参与者和75名对照参与者以及项目2中的78名ASD参与者的核心样本（项目1）。 2例将不招募健康对照）。RAC将负责联系、登记和同意所有 参与者;安排和临床审查的身体检查和认知和行为 评估;以及项目1和项目2评估参与者的时间安排。 目标2.表征和临床，医学，认知和行为评估 参与ACE。RAC将a）获取受试者及其家庭的完整病史; B） 进行身体检查; c）从所有参与者的父母/照顾者（ASD和 对照），包括：ACE受试者病史; ACE家族病史;睡眠习惯问卷 儿童;睡眠习惯问卷;父母;社会反应量表（SRS-2）：斯坦福大学社会维度 量表（SSDS）;重复行为量表，修订版（RBS-R）;限制/重复行为的维度评估 行为量表（DARB）;感觉侧貌问卷（SPQ-2）;儿童行为量表（CBCL）;异常 行为检查表（ABC）和Vineland适应行为量表，第三版（VABS-3）; d） 斯坦福大学Binet 5或马伦早期学习量表（视情况而定），以及NEPSY-2情感识别 对所有参与者（ASD和对照组）进行子测试; e）进行自闭症诊断访谈-修订版（ADI-R）， ASD参与者的父母; f）向ASD参与者管理自闭症诊断观察时间表（ADOS-2）。 g）从对照的父母/照顾者获得社会沟通问卷（SCQ） 参与者 目标3.采集、数据录入、管理并传输至数据管理和分析部门 所有RAC人口统计学、医学、诊断、临床、行为和认知数据的核心（DMAC）。