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

收敛功能不足治疗试验 - 注意力和阅读试验 (CITT-ART)

基本信息

批准号：
8838807
负责人：
MARJEAN T KULP
金额：
$ 22.83万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-05-01 至 2019-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8838807
关键词：
Adherence Advertisements Advertising Aftercare Area Attention Attention deficit hyperactivity disorder Behavior Binocular Vision Caring Castanea dentata Child Child Care Clinical Clinical Trials Clinical Trials Design Cognitive Communities Confidentiality Consent Controlled Clinical Trials Convergence Insufficiency Data Data Coordinating Center Development Documentation Educational Curriculum Eligibility Determination Enrollment Ensure Equipment Ethics Evaluation Eye Future Good Clinical Practice Health Insurance Portability and Accountability Act Health Professional Helsinki Declaration Home environment Human Resources Individual Institutional Review Boards Investigation Lead Letters Long-Term Effects Manuals Masks Measures Methods Newspapers Ohio Optometry Outcome Outcome Measure Parents Participant Patients Pediatrics Pennsylvania Performance Physicians Placebo Control Placebos Policies Privacy Procedures Protocols documentation Psychological reinforcement Psychologist Publications Qualifying Quality Control Randomized Randomized Clinical Trials Reading Records Recruitment Activity Reporting Research Research Personnel Schedule Services Site Surveys Symptoms Testing Training and Education Underrepresented Minority Universities Vision Disorders Visit achievement test aged base college cost design experience follow-up human subject protection interest listening comprehension meetings news primary outcome reading ability reading comprehension secondary outcome teacher treatment effect treatment program treatment trial waiver web site

项目摘要

DESCRIPTION (provided by applicant): This proposal is for The OSU College of Optometry Clinical Center to serve as a clinical center for the Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART), a multicenter randomized, placebo controlled, clinical trial designed to evaluate the effects of treatment for symptomatic convergence insufficiency (Cl) on measures of reading performance and attention in children. 'In this trial, 324 children aged 9 to <14 years with symptomatic Cl will be randomly assigned to 16 weeks of: 1) office-based vergence/ accommodative therapy with home-reinforcement or 2) office-based placebo therapy. After 16 weeks of treatment, the primary outcome measures of reading comprehension (Wechsler Individual Achievement test [WIAT-lll] reading comprehension subtest score) and attention (Strengths and Weaknesses of ADHD Symptoms & Normal Behavior Scale [SWAN]) will be assessed by examiners masked to treatment group. 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. Reading fluency, another test of attention, the Cl Symptom Survey, and clinical measures of Cl (i.e., the near point of convergence, and positive fissional vergence at near) will be other secondary outcome measures; also included will be assessments of key reading and cognitive components that impact reading comprehension including 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 documents our site's ability to recruit at least 36 subjects and to retain them fo 1 year after completion of treatment. Documentation is provided that our site has the appropriate personnel, equipment, and facilities to conduct the study in accordance with the CITT-ART Manual of Procedures (MOP). Complete details of the study rationale, design, and methods are contained in the Manual of Procedures (submitted with the Study Chair and Data Coordinating Center [DCC] applications). In addition to our center, there are 8 other optometric or ophthalmologic centers, the Study Chair at the Pennsylvania College of Optometry at Salus University, and the DCC at The Ohio State University Optometry Coordinating Center. Symptomatic Cl 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,-trouble remembering what was read). However, the effect of Cl 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）：本提案旨在让俄勒冈州立大学视光学院临床中心作为融合不足治疗试验 - 注意力和阅读试验 (CITT-ART) 的临床中心，这是一项多中心随机、安慰剂对照临床试验旨在评估症状性收敛不足（Cl）治疗对儿童阅读表现和注意力测量的影响。 “在这项试验中，324 名 9 岁至 14 岁以下有症状 Cl 的儿童将被随机分配接受为期 16 周的治疗：1）基于办公室的聚散/调节治疗加家庭强化或 2）基于办公室的安慰剂治疗。治疗 16 周后，检查员将评估阅读理解（韦克斯勒个人成绩测试 [WIAT-III] 阅读理解子测试分数）和注意力（ADHD 症状和正常行为量表 [SWAN] 的优点和缺点）的主要结果指标对治疗组进行掩蔽。 Gates MacGinitie-4 测试采用类似于课堂上基于课程的评估的格式，将提供阅读理解能力的次要衡量标准。阅读流畅性、另一项注意力测试、Cl 症状调查和 Cl 的临床测量（即近点收敛和近处的正分裂聚散度）将是其他次要结果测量；还包括对影响阅读理解的关键阅读和认知成分的评估，包括伪单词解码、单词阅读和听力理解。将在治疗后一年评估对阅读成绩和注意力的长期影响。该申请记录了我们的网站有能力招募至少 36 名受试者并在治疗完成后保留他们 1 年。提供的文件表明我们的中心拥有适当的人员、设备和设施，可以根据 CITT-ART 程序手册 (MOP) 进行研究。研究原理、设计和方法的完整细节包含在程序手册中（与研究主席和数据协调中心 [DCC] 申请一起提交）。除了我们的中心外，还有其他 8 个验光或眼科中心、萨鲁斯大学宾夕法尼亚验光学院的研究主席和俄亥俄州立大学验光协调中心的 DCC。症状性视力障碍是儿童中一种常见的视力障碍，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、阅读速度缓慢、难以记住所读内容）。然而，Cl 治疗对阅读和注意力的影响尚不清楚。拟议研究的结果将有助于更好地理解这些关系，并对照顾有阅读和注意力问题的儿童的教育工作者、心理学家和医生产生重要影响。这些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。