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

描述(由申请人提供)：此申请是对FOA PAR-11-045的回应，这是用于智力和发育障碍个人治疗试验的结果衡量标准。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。我们创建了一个反映早期沟通发展层次的量表，称为沟通复杂性量表(CCS)。CCS可用于患有严重残疾的儿童和成人，包括自闭症、瑞德综合征、脆性X综合征(FXS)和安杰曼综合征。重点放在发育早期的交流上，从对环境变化的警觉开始，通过开始使用单词来进行。CCS填补了为早期通信发展提供可靠指数的现有衡量标准的一个重大空白。CCS已经在我们的研究项目中成功地使用了100多个人。在目标1中，我们将评估CCS的心理测量学特性，包括300名不同年龄和残疾类型的新参与者。我们将测量评分员之间以及量表的重测/重测信度、内容效度、同时效度和区分效度。在目标2中，我们将提供关于CCS在不同长度的行为干预的临床试验中测量变化的敏感性的证据，包括学龄前儿童和早期小学儿童。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，我们将调查CCS作为结果衡量标准的效用。在编制了英文和西班牙文的管理和评分手册之后，将完成比额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，即开发和验证结果测量方法，供ID患者在临床试验中使用。

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.