Convergence Insufficiency Treatment Trial - Attention and Reading Trial

收敛不足治疗试验 - 注意力和阅读试验

• 批准号: 9269209
• 负责人: RACHEL Anastasia COULTER
• 金额: $ 5.94万
• 依托单位: NOVA SOUTHEASTERN 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/9269209
• 关键词: Adherence; Advertisements; Aftercare; Attention; Attention deficit hyperactivity disorder; Behavior; Caring; Child; Child Care; Clinical; Clinical Trials; Cognitive; Communities; Consent; 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; Leg; Long-Term Effects; Manuals; Masks; Measures; Methods; Ohio; Ophthalmology; Optometry; Outcome; Outcome Measure; Parents; Participant; Patients; Pennsylvania; Performance; Physicians; Placebo Control; Placebos; Policies; Principal Investigator; Privacy; Procedures; Protocols documentation; Psychological reinforcement; Psychologist; Publications; 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; primary outcome; reading ability; reading comprehension; secondary outcome; symptom treatment; teacher; treatment effect; treatment group; treatment program; treatment trial; trial design; web site

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）：本提案旨在让诺瓦东南大学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，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 名年龄在 9 岁至 <14 岁的有症状 Cl 的儿童将被随机分配接受为期 16 周的治疗：1) 办公室的聚散/调节治疗加家庭强化或 2) 办公室的安慰剂治疗。治疗 16 周后，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的优点和缺点以及正常行为量表 [SWAN]）的主要结局指标将由治疗组的检查员进行评估。 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（即近点会聚和近处的正融合聚散度）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。治疗后一年评估对阅读成绩和注意力的长期影响。该申请记录了我们网站招募至少 36 名受试者并在治疗完成后将其保留 1 年的能力。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 CI 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、阅读速度缓慢以及难以记住所读内容）。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。