The 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: 9094593
• 负责人: RICHARD W HERTLE
• 金额: $ 21.35万
• 依托单位: CHILDREN'S HOSPITAL MED CTR OF AKRON
• 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/9094593
• 关键词: Adherence; Aftercare; Attention; Attention deficit hyperactivity disorder; Behavior; Caring; Child; Child Care; Clinical; Clinical Trials; Clinical Trials Design; Cognitive; Communities; 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; Grant; Helsinki Declaration; Home environment; Human Resources; Individual; Investigation; Lead; Letters; Long-Term Effects; Manuals; Masks; Measures; Methods; Ohio; Optometry; Outcome; Outcome Measure; Parents; Participant; Patients; Pediatric Hospitals; 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; 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; symptom treatment; teacher; treatment effect; treatment group; treatment program; treatment trial

DESCRIPTION (provided by applicant): This proposal is for the Akron Children's Hospital 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 01 Symptom Survey, and clinical measures of 01 (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 OITT-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 [DOO] 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 DOO 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）：本提案旨在将阿克伦儿童医院作为会聚功能不全治疗试验-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，旨在评价症状性会聚功能不全（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至<14岁的有症状的Cl儿童将被随机分配到16周的：1）基于办公室的聚散/聚散治疗与家庭强化或2）基于办公室的安慰剂治疗。治疗16周后，将由对治疗组不知情的检查者评估阅读理解（韦氏个人成就测试[WIAT-III]阅读理解子测试得分）和注意力（ADHD症状和正常行为量表[SWAN]的优势和劣势）的主要结局指标。盖茨·麦克金蒂-4测试，使用类似于课堂上进行的基于成绩的评估的格式，将提供阅读理解的次要衡量标准。阅读流畅性，另一种注意力测试，01症状调查，和01的临床测量（即，近会聚点和近时的正融合聚散）是其它次要结果测量;还包括对影响阅读理解的关键阅读和认知成分的评估，包括伪词解码、词阅读和听力理解。在治疗后1年评估对阅读成绩和注意力的长期影响。 本申请记录了我们的研究中心招募至少36例受试者并在治疗完成后保留1年的能力。提供文件证明我们的研究中心拥有适当的人员、设备和设施，可根据OITT-ART程序手册（MOP）开展研究。研究原理、设计和方法的完整详细信息见程序手册（与研究主席和数据协调中心[DOO]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，Salus大学宾夕法尼亚验光学院的研究主席和俄亥俄州州立大学验光协调中心的DOO。 症状C1是儿童中常见的视觉障碍，其通常与阅读时的症状（例如;位置丢失、注意力不集中、频繁重阅读、阅读慢、以及难以记住所读内容）。然而，氯处理对阅读和注意力的影响尚不清楚。建议的研究结果将导致更好地了解这些关系，并有重要的影响教育工作者，心理学家和医生谁照顾儿童的阅读和注意力问题。这些发现将指导未来视力障碍儿童科学研究的假设发展。