Recruitment and Clinical Assessment Core

招募和临床评估核心

• 批准号: 10698061
• 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/10698061
• 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; autistic children; 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.

招聘和临床评估核心（RAC）将负责a） 参与者； b）审查和/或进行诊断，临床，认知和行为评估； c） 项目1和2的参与者的系统顺序调度； d）数据评分，输入，跟踪， QC程序和数据传输程序到数据管理和分析核心（DMAC）。 RAC 在各个级别上与管理核心（AC）和DMAC相互作用。 RAC的目标是： 目标1。注册180名ASD患者和100个参与ACE的对照，以确保 项目1中的150名ASD和75名对照参与者的核心样本，以及项目2的78名ASD参与者（项目 2将不会注册健康的对照）。 RAC将负责与所有人的联系，入学和同意 参与者；身体检查的日程安排和临床审查以及认知和行为 评估；以及参与者在项目1和2中进行评估的时间表。 目标2。表征和临床，医学，认知和行为评估 参与王牌。 RAC将a）获得参与者和家庭的彻底病史； b） 进行体格检查； c）从所有参与者的父母/照顾者那里获取问卷（ASD和 控制），包括：ACE主题病史；王牌家族病史；睡眠习惯问卷 孩子;睡眠习惯问卷的父母；社会响应量表（SRS-2）：斯坦福大学社会维度 比例尺（SSD）;重复行为量表，修订（RBS-R）；限制/重复的维度评估 行为（darb）；感觉概况问卷（SPQ-2）;儿童行为清单（CBCL）；异常 行为清单（ABC）;和Vineland自适应行为量表，第三版（VABS-3）； d）管理 Stanford Binet 5或适当的早期学习的Mullen量表，Nepsy-2影响识别 对所有参与者（ASD和对照）的子测验； e）管理自闭症诊断访谈（ADI-R） ASD参与者的父母； f）向自闭症诊断观察时间表（ADOS-2）管理 ASD受试者； g）从父母/护理人员控制的社会传播问卷（SCQ） 参与者。 目标3。获取，数据输入，管理和转移到数据管理和分析 所有RAC人群，医学，诊断，临床，行为和认知数据的核心（DMAC）。