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: 9094732
• 负责人: GLADYS L MITCHELL
• 金额: $ 33.51万
• 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/9094732
• 关键词: 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; 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; achievement test; aged; base; behavioral impairment; clinical research site; college; data management; design; developmental disease; electronic data; evidence base; follow-up; improved; listening comprehension; member; primary outcome; reading ability; reading comprehension; reduce symptoms; secondary outcome; success; symptom treatment; symptomatic improvement; teacher; treatment effect; treatment group; 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“收敛功能不全治疗试验-注意力和阅读试验”（cit - art）的资助提案。数据协调中心（DCC）将设在俄亥俄州立大学的视光学院。CITT-ART是一项多中心随机临床试验，旨在评估对症性会聚不全（Cl）治疗对儿童阅读表现和注意力的影响。在这项试验中，324名年龄在9岁至14岁以下的有症状收敛不足的儿童将被随机分配到：1)以办公室为基础的收敛/调节治疗加家庭强化，或2)以办公室为基础的安慰剂治疗加家庭强化。治疗16周后，按治疗组分配的考官将执行主要结果测量：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]）。Gates macginti -4测试采用的形式与课堂上基于课程的评估类似，它将为阅读理解提供第二种衡量标准。其他次要结果测量包括：阅读流畅性测试（WIATT III）、注意力的SNAP测试、CI症状调查、CI的临床测量（即近收敛点和近正向融合点），以及影响阅读理解的关键阅读和认知成分的评估（伪单词解码、单词阅读和听力理解）。治疗一年后将评估对阅读成绩和注意力的长期影响。该申请提供了临床试验设计的基本原理，并描述了DCC的目标和职责。该建议还包括国际贸易中心规划委员会核心成员（包括发展协调委员会人员）以前进行的一些研究结果。症状性CI是儿童中一种常见的视力障碍，通常与阅读时出现的症状有关（例如，迷失位置、注意力不集中、频繁重复阅读、阅读速度慢、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。这项研究的结果将有助于更好地理解这些关系，并对那些关心有阅读和注意力问题的儿童的教育工作者、心理学家和医生具有重要意义。这一发现将指导未来对视力障碍儿童进行科学研究的假设发展。