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)

• 批准号: 8609308
• 负责人: MARJEAN T KULP
• 金额: $ 21.5万
• 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: 2014-05-01 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8609308
• 关键词: Achievement; 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; Comprehension; 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; aged; base; college; cost; design; experience; follow-up; human subject protection; interest; meetings; news; primary outcome; reading ability; reading comprehension; secondary outcome; teacher; treatment effect; treatment program; treatment trial; waiver; web site

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）：该建议是针对OSU验光学院临床中心的临床中心，该中心是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，旨在评估症状融合效果（CL）对阅读表现和阅读表现的症状融合效果（CL）的影响。 '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/带有家庭增强疗法或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-LLL]阅读理解子测验评分）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。阅读流利度，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阳性的裂变效果）将是其他次要结果指标；还包括对关键阅读和认知成分的评估，这些读数和认知成分影响阅读理解，包括伪单词解码，单词读取和听力理解。对阅读成就和注意力的长期影响将在治疗后1年评估。该申请记录了我们网站招募至少36名受试者并在完成治疗后1年保留他们的能力。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，浓度丧失，频繁重新阅读，慢慢阅读“缓慢， - 多头记住阅读的内容）。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。