Convergence Insufficiency Treatment Trial - Attention and Reading Trial

描述（由申请人提供）：这是会聚功能不全治疗试验-注意力和阅读试验（CITT-ART）的主席拨款提案，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。在这项试验中，324名患有症状性CI的9至14岁儿童将被随机分配到：1)以办公室为基础的融合/调节治疗与家庭强化，或2)以办公室为基础的安慰剂治疗与家庭强化。治疗16周后，按治疗组分配的考官将执行主要结果测量：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]）。Gates macginti -4测试采用的形式与课堂上基于课程的评估类似，它将为阅读理解提供第二种衡量标准。其他次要结果测量包括：阅读流畅性测试（WIATT III）、注意力的SNAP测试、CI症状调查、CI的临床测量（即近收敛点和近正向融合点），以及影响阅读理解的关键阅读和认知成分的评估（伪单词解码、单词阅读和听力理解）。治疗一年后将评估对阅读成绩和注意力的长期影响。这份主席的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个参与临床中心的拨款提案。相关性（见说明）：症状性CI是一种常见的儿童视力障碍，通常与阅读时出现的症状相关（例如，迷失位置、注意力不集中、频繁重复阅读、阅读缓慢、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。拟议研究的结果将有助于更好地理解这些关系，并对教育工作者、心理学家、眼科专家和其他照顾有阅读和注意力问题儿童的卫生保健提供者具有重要意义。这一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。

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.