Convergence Insufficiency Treatment Trial - Attention and Reading Trial

收敛不足治疗试验 - 注意力和阅读试验

基本信息

批准号：
8838810
负责人：
RACHEL Anastasia COULTER
金额：
$ 10.44万
依托单位：
NOVA SOUTHEASTERN 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/8838810
关键词：
Adherence Advertisements Aftercare Attention Attention deficit hyperactivity disorder Behavior Caring 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 Helsinki Declaration Home environment Human Resources Individual Institutes Investigation Lead Long-Term Effects Manuals Masks Measures Methods Ohio Optometry Outcome Outcome Measure Parents Participant Patients Pennsylvania Performance Physicians Placebo Control Placebos Policies Principal Investigator Privacy Procedures Protocols documentation Psychological reinforcement Psychologist Publications Qualifying Quality Control Randomized Randomized Clinical Trials Reading Records Recruitment Activity Reporting Schedule Site Surveys Symptoms Testing Training and Education Underrepresented Minority Universities Vision Disorders Visit achievement test aged base college design experience follow-up human subject protection interest listening comprehension meetings primary outcome reading ability reading comprehension secondary outcome teacher treatment effect treatment program treatment trial web site

项目摘要

DESCRIPTION (provided by applicant): This proposal is for the Nova Southeastern University 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-III]) 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 fusional vergence at near) are other secondary outcome measures; also included are 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 are assessed 1-year post treatment. This application documents our site's ability to recruit at least 36 subjects and to retain them for 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, and 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）：该提案旨在Nova东南大学作为收敛性不足治疗试验的临床中心 - 注意力和阅读试验（CITT -ART），这是一项多中心随机，安慰剂控制的临床试验，旨在评估治疗效果的症状融合效果（CL）对儿童阅读表现的效果。在这项试验中，有324名9至<14岁的儿童患有症状CL的儿童将随机分配到16周的：1）基于办公室的Gergence/带有家庭增强的适应性治疗或2）基于办公室的安慰剂疗法。经过16周的治疗后，阅读理解的主要结果度量（Wechsler个人成就测试[WIAT-III]）阅读理解理解子测试评分和注意力（ADHD症状和正常行为量表的优势和劣势[SWAN]）将由掩盖到治疗组的审查员评估。 Gates MacGinitie-4测试使用类似于教室中基于课程的评估的格式，将提供阅读理解的次要度量。读取流利度，另一个注意力测试，CL症状调查以及CL的临床测量（即接近收敛的近点和正融合的阳性）是其他次要结果指标；还包括对关键阅读和认知组件的评估，这些评估影响阅读理解，包括伪单词解码，单词读取和听力理解。在治疗后为期1年，评估对阅读成就和注意力的长期影响。该申请记录了我们网站至少招募36名受试者并在治疗完成后将其保留1年的能力。提供了文件，我们的网站具有适当的人员，设备和设施，可以按照CITT-ART程序手册（MOP）进行研究。研究原理，设计和方法的完整详细信息包含在手册中（与研究主席和数据协调中心[DCC]应用程序提交）。除我们的中心外，还有其他8个验光或眼科中心，宾夕法尼亚州萨勒斯大学验光学院的学习主席和俄亥俄州立大学验光协调中心的DCC。有症状的CL是儿童常见的视力障碍，在阅读时通常与症状相关（例如失去位置，集中度的丧失，频繁重新阅读，缓慢阅读以及难以记住所读的内容）。但是，CL治疗对阅读和注意力的影响尚不清楚。拟议研究的结果将使人们更好地理解这些关系，并对关心有阅读和注意力问题的孩子的教育者，心理学家和医生具有重要意义。这些发现将指导假设发展视力障碍儿童的未来科学研究。