The CCS: A Treatment Outcome Measure for Individuals with Severe ID

CCS：严重智力障碍患者的治疗结果衡量标准

• 批准号: 8695425
• 负责人: NANCY CAROLINE BRADY
• 金额: $ 35.15万
• 依托单位: UNIVERSITY OF KANSAS LAWRENCE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-05 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8695425
• 关键词: Address; Adult; Age; Algorithms; Angelman Syndrome; Autistic Disorder; Behavior Therapy; Child; Clinical Trials; Code; Collaborations; Communication; Communications Media; Development; Diagnosis; E-learning; Environment; Etiology; Floods; Floor; Focus Groups; Fragile X Syndrome; Funding; Grant; Individual; Intellectual functioning disability; Intervention; Kansas; Length; Manuals; Measures; Nursery Schools; Outcome; Outcome Measure; Participant; Patients; Performance; Population; Prader-Willi Syndrome; Property; Psychometrics; Publications; Recruitment Activity; Relative (related person); Research; Research Personnel; Research Project Grants; Sampling; Subgroup; Syndrome; Testing; Training; Treatment outcome; Underserved Population; United States National Institutes of Health; Validity and Reliability; aged; alertness; base; disability; experience; indexing; innovation; intellectual and developmental disability; programs; public health relevance; response; skills; tool; treatment trial; usability; Address; Adult; Age; Algorithms; Angelman Syndrome; Autistic Disorder; Behavior Therapy; Child; Clinical Trials; Code; Collaborations; Communication; Communications Media; Development; Diagnosis; E-learning; Environment; Etiology; Floods; Floor; Focus Groups; Fragile X Syndrome; Funding; Grant; Individual; Intellectual functioning disability; Intervention; Kansas; Length; Manuals; Measures; Nursery Schools; Outcome; Outcome Measure; Participant; Patients; Performance; Population; Prader-Willi Syndrome; Property; Psychometrics; Publications; Recruitment Activity; Relative (related person); Research; Research Personnel; Research Project Grants; Sampling; Subgroup; Syndrome; Testing; Training; Treatment outcome; Underserved Population; United States National Institutes of Health; Validity and Reliability; aged; alertness; base; disability; experience; indexing; innovation; intellectual and developmental disability; programs; public health relevance; response; skills; tool; treatment trial; usability

DESCRIPTION (provided by applicant): This application is in response to FOA PAR-11-045, Outcome Measures for Use in Treatment trials for Individuals with Intellectual and Developmental Disabilities. We propose to further develop and validate an endpoint measure of communication for use in clinical trials research. We created a scale that reflects the developmental hierarchy of early communication, referred to as the Communication Complexity Scale (CCS). The CCS can be used with children and adults with severe disabilities including individuals with autism, Rhett syndrome, Fragile X syndrome (FXS), and Angelman syndrome. The focus is on developmentally early communication, beginning with alertness to changes in the environment and progressing through beginning word use. The CCS fills a significant gap in available measures that provide a reliable index of early communication development. The CCS has been used successfully in our research projects with over 100 individuals. In Aim 1 we will evaluate the psychometric properties of the CCS with 300 new participants across ages and types of disabilities. We will measure inter-rater and test/retest reliability of the scale, conten validity, concurrent validity, and discriminant validity. In Aim 2, we will provide evidence about the sensitivity of the CCS to measure change in clinical trials for behavioral interventions of varying lengths, with both preschool and early elementary-aged children. Aim 2 will be accomplished in collaboration with researchers at UCLA. In Aim 3 we will investigate the utility of the CCS as an outcome measure. Following the development of an administration and scoring manual in both English and Spanish, usability testing of the scale and training materials will be completed. Through this research, we will be addressing a critical need identified by NIH to develop and validate outcome measures for use in clinical trials by individuals with ID.

描述（由申请人提供）：此申请是响应FOA PAR-11-045，用于智力和发育障碍患者治疗试验的结果指标。我们建议进一步开发和验证用于在临床试验研究中使用的通信端点度量。我们创建了一个反映早期交流的发展层次结构的量表，称为通信复杂性量表（CCS）。 CC可以与患有严重残疾的儿童和成人一起使用，包括自闭症患者，瑞德综合症，脆弱X综合征（FXS）和Angelman综合征。重点是发展早期交流，从对环境变化的警觉开始，并通过开始使用单词来进行。 CCS在可用措施中填补了很大的空白，这些措施提供了可靠的早期交流开发指数。 CCS已在我们的研究项目中成功使用了100多名个人。在AIM 1中，我们将评估CCS的心理测量特性，其中300名跨年龄和类型的新参与者。我们将衡量评估者间和测试/重新测试/重新测试的可靠性，有效性，并发有效性和判别有效性。在AIM 2中，我们将提供有关CCS对临床试验的敏感性的敏感性的证据。 AIM 2将与UCLA的研究人员合作完成。在AIM 3中，我们将调查CCS作为结果度量的效用。在使用英语和西班牙语制定了政府和评分手册之后，将完成对规模和培训材料的可用性测试。通过这项研究，我们将解决NIH确定的关键需求，以制定和验证有ID个人在临床试验中使用的结果指标。