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: 9108404
• 负责人: MITCHELL M SCHEIMAN
• 金额: $ 60.88万
• 依托单位: SALUS 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/9108404
• 关键词: Aftercare; Age; Applications Grants; Attention; Attention deficit hyperactivity disorder; Behavior; Binocular Vision; Blindness; Blurred vision; Budgets; Chairperson; Child; Child Care; Childhood; Clinical; Clinical Trials; Clinical Trials Design; Cognitive; Control Groups; Controlled Clinical Trials; Convergence Insufficiency; Data; Data Coordinating Center; Development; Diplopia; Educational Curriculum; Evaluation; Eye; Funding; Future; Headache; Health Personnel; Home environment; Individual; Instruction; Intervention; Investigation; Lead; Long-Term Effects; Manuals; Masks; Measures; Oral; Outcome; Outcome Measure; Parents; Participant; Performance; Pilot Projects; Placebo Control; Placebos; Principal Investigator; Procedures; Psychological reinforcement; Psychologist; Randomized; Randomized Clinical Trials; Reading; Reporting; Research; Resolution; S-nitro-N-acetylpenicillamine; Speed; Surveys; Symptoms; Testing; Vision Disorders; Work; achievement test; aged; base; behavioral impairment; developmental disease; evidence base; follow-up; improved; innovation; listening comprehension; primary outcome; reading ability; reading comprehension; reading difficulties; reduce symptoms; secondary outcome; success; symptom treatment; symptomatic improvement; teacher; treatment effect; treatment group; treatment trial

DESCRIPTION (provided by applicant): This is the Chairman's grant proposal for the Convergence insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART), a randomized, placebo controlled, clinical trial designed to test the effects of convergence insufficiency (CI) treatment on measures of reading performance and attention. In this trial, 324 children aged 9 to <14 years with symptomatic CI will be randomly assigned to: 1) office- based vergence/accommodative therapy with home-reinforcement or 2) office-based placebo therapy with home reinforcement. After 16 weeks of treatment, examiners masked to treatment group assignment will administer the primary outcome measures for: 1) reading comprehension (Wechsler Individual Achievement test [WIAT-III]) reading comprehension subtest and 2) attention (Strengths & Weaknesses of ADHD Symptoms & Normal Behavior Scale [SWAN]). 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. Other secondary outcome measures include: a test of reading fluency (WIATT III), the SNAP test of attention, the CI Symptom Survey, clinical measures of CI (i.e., near point of convergence and positive fusional vergence at near), and assessments of key reading and cognitive components that impact reading comprehension (pseudo word decoding, word reading, and listening comprehension). Long-term effects on reading achievement and attention will be assessed 1-year post treatment. This Chairman's grant proposal provides the significance, innovation, and approach for the clinical trial including the results of preliminary studies, and the budget for th Study Chairman's office and functions. Accompanying documents include the CITT-ART Manuals of Procedures, and grant proposals from the CITT-ART Data Coordinating Center and 9 participating Clinical Centers. RELEVANCE (See instructions): Symptomatic CI is a common childhood vision disorder frequently 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 CI treatment on reading and attention is unknown. Results from the proposed study will lead to a better understanding of these relationships and have important implications for educators, psychologists, eye professionals, and other health care providers 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）：这是主席对会聚功能不全治疗试验-注意力和阅读试验（CITT-ART）的资助提案，这是一项随机、安慰剂对照的临床试验，旨在测试会聚功能不全（CI）治疗对阅读表现和注意力的影响。在该试验中，324名9至<14岁的症状性CI儿童将被随机分配至：1）基于办公室的聚散/发散疗法与家庭强化或2）基于办公室的安慰剂疗法与家庭强化。治疗16周后，对治疗组分配不知情的检查者将实施以下主要结局指标：1）阅读理解（韦氏个人成就测试[WIAT-III]）阅读理解子测试和2）注意力（ADHD症状和正常行为量表[SWAN]的优势和劣势）。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。其他次要结果测量包括：阅读流畅性测试（WIATT III）、注意力SNAP测试、CI症状调查、CI的临床测量（即，近会聚点和近时的正融合聚散），以及对影响阅读理解的关键阅读和认知成分（伪词解码、词阅读和听力理解）的评估。将在治疗后1年评估对阅读成绩和注意力的长期影响。本主席拨款提案提供了临床试验的意义、创新和方法，包括初步研究的结果，以及研究主席办公室和职能的预算。随附文件包括CITT-ART程序手册，以及CITT-ART数据协调中心和9个参与临床中心的资助提案。相关性（参见说明）：症状CI是一种常见的儿童视力障碍，通常与阅读时的症状相关（例如，位置丢失、注意力不集中、频繁重新阅读、阅读缓慢以及难以记住所读内容）。然而，CI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了解这些关系，并对教育工作者、心理学家、眼科专业人员和其他照顾有阅读和注意力问题的儿童的医疗保健提供者具有重要影响。这些发现将指导未来视力障碍儿童科学研究的假设发展。