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

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）：本申请是对FOA PAR-11-045《用于智力和发育障碍个体治疗试验的结局指标》的回应。我们建议进一步开发和验证用于临床试验研究的通信终点测量。我们创建了一个规模，反映了早期沟通的发展层次，被称为通信复杂性规模（CCS）。CCS可用于患有严重残疾的儿童和成人，包括患有自闭症、Rhett综合征、脆性X综合征（FXS）和Angelman综合征的个体。重点是发展早期的沟通，从对环境变化的警觉开始，并通过开始使用单词来进步。综合传播战略填补了现有措施中的一个重大空白，为早期传播发展提供了可靠的指数。CCS已成功地用于我们的研究项目，有100多人。在目标1中，我们将与300名不同年龄和残疾类型的新参与者一起评估CCS的心理测量特性。我们将测量量表的评分者间和测试/重测信度、内容效度、并发效度和判别效度。在目标2中，我们将提供有关CCS测量不同长度行为干预临床试验变化的敏感性的证据，包括学龄前和小学早期儿童。目标2将与加州大学洛杉矶分校的研究人员合作完成。在目标3中，我们将研究CCS作为结局指标的效用。在用英文和西班牙文编写行政和评分手册之后，将完成量表和培训材料的可用性测试。通过这项研究，我们将解决NIH确定的一个关键需求，即开发和验证用于ID患者临床试验的结果指标。