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)：这项建议是由俄亥俄州立大学视光临床中心作为收敛不足治疗试验-注意力和阅读试验(CITT-ART)的临床中心，该试验是一项多中心随机、安慰剂对照的临床试验，旨在评估症状性收敛不足(CL)治疗对儿童阅读成绩和注意力测量的影响。在这项试验中，324名9岁至14岁的有症状的儿童将被随机分配到16周：1)基于办公室的强化/调节治疗和家庭强化；2)基于办公室的安慰剂治疗。治疗16周后，对阅读理解(韦氏个人成就测验[WIAT-11]阅读理解分测验)和注意力(ADHD症状的强弱和正常行为量表[SWAN])的主要结果进行评估，并由隐蔽到治疗组的检查员进行评估。盖茨的MacGInitie-4考试使用的形式类似于课堂上进行的基于课程的评估，它将提供阅读理解的次要测试。阅读流畅性、注意力的另一项测试、认知症状调查和认知能力的临床测量(即近汇聚点和正分裂聚集点)将是其他次要结果；还将包括对影响阅读理解的关键阅读和认知成分的评估，包括伪词解码、词阅读和听力理解。对阅读成绩和注意力的长期影响将在治疗后一年进行评估。这份申请证明我们的网站有能力招募至少36名受试者，并在完成治疗后将他们保留一年。根据CITT-ART程序手册(MOP)，我们的网站有适当的人员、设备和设施来进行研究。研究的基本原理、设计和方法的完整细节载于《程序手册》(与研究主席和数据协调中心[DCC]申请书一起提交)。除了我们的中心，还有其他8个视光或眼科中心，萨卢斯大学宾夕法尼亚视光学院的研究教席，以及俄亥俄州立大学视光协调中心的DCC。症状性CL是一种常见的儿童视力障碍，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、阅读速度慢-难以记住所读的内容)。然而，氯离子处理对阅读和注意力的影响尚不清楚。这项拟议的研究结果将有助于更好地理解这些关系，并对关心阅读和注意力问题儿童的教育者、心理学家和医生具有重要的意义。这些发现将指导假说的发展，为未来对视力障碍儿童的科学研究提供指导。