Outcome of Sensory-Based Intervention after Birth Trauma

产伤后基于感觉的干预的结果

• 批准号: 6430030
• 负责人: LUCY J MILLER
• 金额: $ 11.3万
• 依托单位: CHILDREN'S HOSPITAL OF DENVER
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-24 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6430030
• 关键词: birth injury; child (0-11); experimental designs; human subject; medical rehabilitation related tag; occupational therapy; patient oriented research; rehabilitation

DESCRIPTION (provided by applicant): The investigators will plan a multi-site Phase III clinical trial of a sensory-based rehabilitation for children who suffer traumatic birth injuries. Collaborators are renowned occupational therapists from three universities and three direct service programs, with decades of experience. They are assisted by three expert consultants and three Research Advisory Councils, constituted of national experts who reside near each local team. The Research Advisory Councils will meet with the regional teams to assist with planning and will meet with the national team once when the team meets at their site. Twenty percent of children with traumatic birth injuries are treated for major disorders, and another 20% have no sequelae of birth trauma. This planning grant focuses on the remaining 60% who suffer hidden handicaps, e.g. subtle limitations and disabilities, not usually identified until the children fail school. One such hidden handicap is Sensory Modulation Dysfunction, a disability manifested by severe difficulties regulating responses to sensory input, that occurs in the absence of any frank peripheral or central nervous system damage. Children with SMD have such extreme over-responsivity to sensation that the child and family's daily life routines are substantially disrupted. The investigators will plan a Phase III masked randomized prospective clinical trial across three diverse geographic regions (CO, CA, MA). The complex process of planning Phase III clinical trials is problematic in OT, because a well-established clinical research infrastructure does not exist. This grant will provide a mechanism for the first time in the history of OT to carefully plan a multisite study to evaluate the effectiveness of this form of pediatric rehabilitation. Hypotheses for a Phase III Clinical Trial: The investigators hypothesize that children with significant birth trauma, who receive a specific type of sensory- based OT rehabilitation intervention will have (a) positive psychophysiological changes (e.g., electrodermal activity and vagal tone); (b) improved impulse control (attention) and emotion regulation; improved self- care, coping, and social participation at home and at school; and (d) better sustainability of family routines due to decreased parental stress. Aims for one-year Planning Grant: The investigators will plan and write an R01, to submit at the end of the planning period. They will convene four one- week meetings quarterly, have bi-monthly conference calls, and complete individual tasks. This will permit (1) the definition of specific inclusion/exclusion criteria, (2) the selection of outcome measures across NCMRR levels of disablement, (3) characterization of the exact intervention protocol, (4) specification of a method to measure fidelity to the treatment model, and (5) specification of data analysis and interpretation methods.

描述(申请人提供)：调查员将规划一个多地点 儿童感觉型康复的第三阶段临床试验 遭受创伤性出生损伤。合作者是著名的职业人士 来自三所大学和三个直接服务项目的治疗师， 几十年的经验。他们由三名专家顾问和三名专家顾问协助。 研究咨询委员会，由居住在附近的国家专家组成 每一支当地球队。研究咨询委员会将与区域 球队协助规划，将在以下情况下与国家队会面一次 团队在他们的工地会面。20%有创伤分娩的儿童 受伤的人治疗严重的疾病，另有20%的人没有后遗症 出生创伤。这项计划拨款集中在剩下的60%的受难者身上。 隐藏的障碍，例如微妙的限制和残疾，通常不会 直到孩子们不能上学为止。其中一个隐藏的障碍是感官 调制功能障碍，一种表现为严重困难的残疾 调节对感觉输入的反应，在没有任何坦率的情况下发生 外周或中枢神经系统受损。患有SMD的儿童有这样的症状 对孩子和家庭的日常生活感到极度过度反应 例行公事基本上被打乱了。调查人员将计划第三阶段 三个不同地域的掩蔽随机前瞻性临床试验 区域(CO、CA、MA)。计划三期临床的复杂过程 试验在OT中是有问题的，因为一项成熟的临床研究 基础设施不存在。这笔赠款将提供一种机制， 在OT历史上第一次仔细计划进行多站点研究 评估这种形式的儿科康复的有效性。 第三阶段临床试验的假设：研究人员假设 有严重出生创伤的儿童，他们接受特定类型的 基于感觉的加班康复干预将有(A)积极的作用 心理生理变化(例如，皮肤电活动和迷走神经紧张度)； 改善冲动控制(注意力)和情绪调节；改善自我 家庭和学校的照顾、应对和社会参与；和(D)更好 由于父母压力的减少，家庭日常生活的可持续性。 为期一年的计划拨款：调查人员将计划并撰写一份 R01，在规划期结束时提交。他们将召集四个一- 每季度召开一次会议，每两个月召开一次电话会议，并完成 单独的任务。这将允许(1)特定的定义 纳入/排除标准，(2)在以下方面选择成果衡量标准 NCMRR致残水平，(3)确切干预的特征 协议，(4)测量治疗保真度的方法的规范 模型，以及(5)数据分析和解释方法的规范。