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.

招募和临床评估核心 (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) 项目 1 和 2 中参与者的系统顺序安排； 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 与各级管理核心 (AC) 和 DMAC 进行交互。 RAC 的目标是： 目标 1. 招募 180 名 ASD 患者和 100 名对照者参与 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（项目 2 不会招募健康对照）。 RAC 将负责联系、登记并征得所有 参与者；身体检查以及认知和行为的安排和临床审查 评估；以及项目 1 和 2 评估参与者的安排。 目标 2. 特征描述以及临床、医学、认知和行为评估 参与 ACE。 RAC 将 a) 获取参与者及其家人的完整病史； b) 进行身体检查； c) 从所有参与者（ASD 和 控制），包括：ACE 科目病史； ACE 家族病史；睡眠习惯问卷 孩子;睡眠习惯问卷家长；社会反应量表 (SRS-2)：斯坦福社会维度 秤（SSDS）；重复行为量表，修订版（RBS-R）；限制/重复的尺寸评估 行为（DARB）；感官概况调查问卷（SPQ-2）；儿童行为检查表（CBCL）；异常 行为检查表（ABC）；和 Vineland 适应性行为量表，第三版 (VABS-3)； d) 管理 斯坦福 Binet 5 或 Mullen 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）进行分测试； e) 进行自闭症诊断访谈修订版 (ADI-R) ASD 参与者的父母； f) 对自闭症诊断观察表（ADOS-2）进行管理 自闭症谱系障碍科目； g) 从控制者的父母/照顾者那里获取社交沟通问卷 (SCQ) 参与者。 目标 3. 采集、数据输入、管理以及传输到数据管理和分析 所有 RAC 人口统计、医疗、诊断、临床、行为和认知数据的核心 (DMAC)。