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

收敛不足治疗试验 - 注意力和阅读试验（CITT-ART）

• 批准号: 8609307
• 负责人: GLADYS L MITCHELL
• 金额: $ 41.8万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-01 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8609307
• 关键词: Achievement; Aftercare; Age; Applications Grants; Attention; Attention deficit hyperactivity disorder; Behavior; Binocular Vision; Blindness; Blurred vision; Child; Child Care; Clinical; Clinical Trials; Clinical Trials Design; Cognitive; Comprehension; Convergence Insufficiency; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Development; Diplopia; Educational Curriculum; Evaluation; Funding; Future; Goals; Headache; Home environment; Housing; Human Resources; Individual; Internet; Intervention; Investigation; Lead; Location; Long-Term Effects; Manuals; Masks; Measures; Methods; Ohio; Optometrist; Optometry; Oral; Outcome; Outcome Measure; Parents; Participant; Performance; Physicians; Placebo Control; Placebos; Principal Investigator; Procedures; Protocols documentation; Psychological reinforcement; Psychologist; Quality Control; Randomized; Randomized Clinical Trials; Reading; Reporting; Research; Research Design; Resolution; Role; S-nitro-N-acetylpenicillamine; Secure; Surveys; Symptoms; System; Testing; Universities; Vision Disorders; Work; aged; base; behavioral impairment; clinical research site; college; data management; design; developmental disease; electronic data; evidence base; follow-up; improved; member; primary outcome; reading ability; reading comprehension; secondary outcome; success; teacher; treatment effect; treatment trial

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.

描述（由申请人提供）：这是数据协调中心对会聚不足治疗试验-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，旨在评价治疗症状性会聚功能不全（Cl）对儿童阅读表现和注意力的影响。在这项试验中，324名9至<14岁的症状性会聚功能不全儿童将被随机分配到：1）以办公室为基础的聚散/矫正治疗与家庭强化或2）以办公室为基础的安慰剂治疗与家庭强化。治疗16周后，对治疗组分配不知情的检查者将实施以下主要结局指标：1）阅读理解（韦氏个人成就测试[WIAT-III]）阅读理解子测试和2）注意力（ADHD症状和正常行为量表[SWAN]的优势和劣势）。盖茨·麦克金蒂-4测试，使用类似于课堂上进行的基于成绩的评估的格式，将提供阅读理解的次要衡量标准。其他次要结果测量包括：阅读流畅性测试（WIATT III）、注意力SNAP测试、CI症状调查、CI的临床测量（即，近会聚点和近时的正融合聚散），以及对影响阅读理解的关键阅读和认知成分（伪词解码、词阅读和听力理解）的评估。将在治疗后1年评估对阅读成绩和注意力的长期影响。本申请提供了临床试验设计的基本原理以及DCC的目标和职责描述。该提案还包括CITT计划委员会核心成员（包括DCC人员）先前进行的研究的一些结果。 CI症状是儿童常见的视力障碍，通常与阅读时的症状相关（例如，位置丢失、注意力不集中、频繁重复阅读、阅读缓慢以及难以记住所读内容）。然而，CI治疗对阅读和注意力的影响尚不清楚。拟议的研究结果将导致更好地理解这些关系，并对教育工作者，心理学家和医生谁照顾儿童的阅读和注意力问题具有重要意义。这些发现将指导未来视力障碍儿童科学研究的假设发展。