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: 9274971
• 负责人: MITCHELL M SCHEIMAN
• 金额: $ 34.62万
• 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/9274971
• 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; Cognitive; Control Groups; Convergence Insufficiency; Data; Data Coordinating Center; Development; Diplopia; Educational Curriculum; Evaluation; Eye; Funding; Future; Headache; Health Personnel; Home environment; Individual; Instruction; Intervention; Investigation; 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; Recruitment Activity; 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 analysis; secondary outcome; success; symptom treatment; teacher; treatment effect; treatment group; treatment trial; trial design

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)：这是汇聚性功能不全治疗试验-注意力和阅读试验(CITT-ART)的主席拨款建议，这是一项随机、安慰剂对照的临床试验，旨在测试汇聚性功能不全(CI)治疗对阅读成绩和注意力测量的影响。在这项试验中，324名患有症状性脑梗塞的9岁至14岁的儿童将被随机分配到：1)基于办公室的强化/调节治疗，配合家庭强化；2)基于办公室的安慰剂治疗，配合家庭强化。治疗16周后，蒙面到治疗组的考官将进行以下主要结果测量：1)阅读理解(韦氏个人成就测验[WIAT-III])阅读理解分测试和2)注意力(ADHD症状的长处和弱点和正常行为量表[天鹅])。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。其他次要结果测量包括：阅读流利性测试(Wiatt III)，SNAP注意力测试，CI症状调查，CI的临床测量(即接近汇合点和近距离的正融合趋同)，以及对影响阅读理解的关键阅读和认知成分的评估(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。这项主席拨款方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。随附的文件包括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建议。相关性(见说明)：症状性CI是一种常见的儿童视力障碍，经常与阅读时的症状有关(例如，失去位置、注意力不集中、频繁重复阅读、阅读缓慢以及难以记住所读的内容)。然而，脑梗塞治疗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儿童的卫生保健提供者具有重要意义。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。