Convergence Insufficiency Treatment Trial- Attention and Reading Trial (CITT-ART)

描述(申请人提供)：这是数据协调中心对汇聚性功能不全治疗试验-注意力和阅读试验(CITT-ART)的资助提案。数据协调中心(DCC)将设在俄亥俄州立大学的验光学院。CITT-ART是一项多中心随机临床试验，旨在评估症状性收敛功能不全(CL)治疗对儿童阅读成绩和注意力的影响。在这项试验中，324名9岁至14岁患有症状性收敛功能不全的儿童将被随机分配到：1)基于办公室的融合/调节治疗加家庭强化，或2)基于办公室的安慰剂治疗加家庭强化。治疗16周后，蒙面到治疗组的考官将进行以下主要结果测量：1)阅读理解(韦氏个人成就测验[WIAT-III])阅读理解分测试和2)注意力(ADHD症状的长处和弱点和正常行为量表[天鹅])。盖茨的MacGInitie-4考试使用的形式类似于课堂上进行的基于课程的评估，它将提供阅读理解的次要测试。其他次要结果测量包括：阅读流利性测试(Wiatt III)，SNAP注意力测试，CI症状调查，CI的临床测量(即接近汇合点和近距离的正融合趋同)，以及对影响阅读理解的关键阅读和认知成分的评估(伪词解码、词阅读和听力理解)。对阅读成绩和注意力的长期影响将在治疗后一年进行评估。这项申请为临床试验的设计提供了理论基础，并描述了DCC的目标和责任。该提案还包括电信技术委员会规划委员会核心成员，包括DCC人员以前进行的研究的一些结果。症状性CI是一种常见的儿童视力障碍，通常与阅读时的症状有关(例如，失去位置、注意力不集中、频繁重读、阅读缓慢，以及难以记住所读的内容)。然而，脑梗塞治疗对阅读和注意力的影响尚不清楚。这项拟议的研究结果将有助于更好地理解这些关系，并对关心阅读和注意力问题儿童的教育者、心理学家和医生具有重要意义。这些发现将指导假说的发展，为未来对视力障碍儿童的科学研究提供指导。

DESCRIPTION (provided by applicant): This is the data coordinating center's grant proposal for the Convergence Insufficiency Treatment Trial- Attention and Reading Trial (CITT-ART). The Data Coordinating Center (DCC) will be housed in the College of Optometry at The Ohio State University. The CITT-ART is a multi-center randomized clinical trial designed to evaluate the effects of treatment for symptomatic convergence insufficiency (Cl) on reading performance and attention in children. In this trial, 324 children aged 9 to <14 years with symptomatic convergence insufficiency will be randomly assigned to: 1) office-based vergence/ accommodative therapy with home-reinforcement or 2) office-based placebo therapy with home reinforcement. After 16 weeks of treatment, examiners masked to treatment group assignment will administer the primary outcome measures for: 1) reading comprehension (Wechsler Individual Achievement test [WIAT-III]) reading comprehension subtest and 2) attention (Strengths & Weaknesses of ADHD Symptoms & Normal Behavior Scale [SWAN]). The Gates MacGinitie-4 test, which uses a format similar to curriculum-based evaluation done in classrooms, will provide a secondary measure of reading comprehension. Other secondary outcome measures include: a test of reading fluency (WIATT III), the SNAP test of attention, the CI Symptom Survey, clinical measures of CI (i.e., near point of convergence and positive fusional vergence at near), and assessments of key reading and cognitive components that impact reading comprehension (pseudo word decoding, word reading, and listening comprehension). Long-term effects on reading achievement and attention will be assessed 1-year post treatment. This application provides the rationale for the design of the clinical trial ad a description of the goals and responsibilities of the DCC. This proposal also includes some results from previous studies performed by the core members of the CITT planning committee including personnel from the DCC. Symptomatic CI is a common vision disorder in children that is commonly associated with symptoms while reading (e.g. loss of place, loss of concentration, frequent re-reading, reading slowly, and trouble remembering what was read). However, the effect of CI treatment on reading and attention is unknown. The results of the proposed study will lead to a better understanding of these relationships and have important implications for educators, psychologists, and physicians who care for children with reading and attention problems. The findings will guide hypothesis development for future scientific investigations in children with vision disorders.