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Recruitment and Clinical Assessment Core

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:
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
未结题
起止时间:
2022-09-06 至 2027-08-31

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中文摘要
翻译
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) 对项目1和项目2的参与者进行系统的顺序调度;以及d)数据评分、条目、跟踪、 QC程序和数据传输程序至数据管理和分析核心(DMAC)。RAC 与所有级别的管理核心(AC)和DMAC进行交互。区域咨询委员会的目标是: 目标1.招募180名ASD患者和100名对照参加ACE,以确保 核心样本包括项目1中的150名ASD参与者和75名对照参与者,以及项目2(Project)中78名ASD参与者 2将不会登记健康对照)。RAC将负责联系、登记和同意所有 参与者:体检时间安排和临床回顾以及认知和行为 评估;以及安排参与者参加项目1和2的评估。 目标2.患者的特征和临床、医学、认知和行为评估 参加ACE。咨询委员会将a)获取参与者及其家庭的详细病史;b) 进行体检;c)从所有参与者(自闭症和自闭症患者)的父母/照顾者那里获得问卷 对照),包括:ACE对象病史;ACE家族病史;睡眠习惯问卷 儿童;睡眠习惯问卷;父母;社会反应性量表(SRS-2):斯坦福社会维度 量表(SSDS);重复行为量表修订版(RBS-R);限制性/重复维度评估 行为量表;感觉特征问卷;儿童行为量表;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 斯坦福比奈5或早期学习马伦量表,以及NEPSY-2影响认知 对所有参与者(自闭症和对照)进行分测试;e)进行自闭症诊断访谈-修订(ADI-R)以 自闭症患者的父母;f)将自闭症诊断观察表(ADOS-2)管理到 自闭症受试者;以及g)从父母/照顾者那里获得社会沟通问卷(SCQ 参与者。 目标3.获取、数据录入、管理并传输至数据管理和分析 所有RAC人口统计、医疗、诊断、临床、行为和认知数据的核心(DMAC)。
英文摘要
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.
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Recruitment and Clinical Assessment Core
  • 批准号:
    10698061
  • 项目类别:
  • 资助金额:
    $31.35万
  • 财政年份:
    2022
  • 负责人:
    JOACHIM F HALLMAYER
  • 依托单位:
Center for Sleep in Autism Spectrum Disorder
  • 批准号:
    10531469
  • 项目类别:
  • 资助金额:
    $194.92万
  • 财政年份:
    2022
  • 负责人:
    JOACHIM F HALLMAYER
  • 依托单位:
Administrative Core
  • 批准号:
    10531470
  • 项目类别:
  • 资助金额:
    $15.71万
  • 财政年份:
    2022
  • 负责人:
    JOACHIM F HALLMAYER
  • 依托单位:
Center for Sleep in Autism Spectrum Disorder
  • 批准号:
    10698028
  • 项目类别:
  • 资助金额:
    $194.59万
  • 财政年份:
    2022
  • 负责人:
    JOACHIM F HALLMAYER
  • 依托单位:
海外基金