Headstrong Intervention for Recurrent Pediatric Headache

描述(由申请人提供)：复发性儿童头痛是一种慢性疼痛综合征，影响着200多万美国儿童，经常导致严重的功能残疾和虚弱。此外，这种综合征给患者的家庭和卫生保健系统带来了巨大的成本。本研究的目的是评估一种新的具有成本效益的方法治疗复发性儿童头痛的有效性，该方法允许儿童学习如何通过CD-ROM计划(称为“Headstrong TM”)自我管理他们的头痛。这项赠款提案是对PA-01-115的响应，PA-01-115呼吁进行研究，寻求确定和完善针对特定疼痛状况的创新和有效的治疗策略。一项随机试验将用于评估Headstrong TM干预的有效性。108名儿童患者，年龄7-12岁，被诊断为复发性偏头痛、肌肉收缩或慢性日常头痛综合征，将被纳入研究。登记后，每个患者的基线头痛频率、持续时间和强度将使用头痛日记进行为期一个月的评估。在这一个月的基线期间，我们还将收集数据，以检查与头痛相关的残疾和与健康相关的生活质量。在基线之后，患者将被随机分配到标准医疗护理+Headstrong TM干预或标准医疗护理+教育条件(也是一个光盘计划，其中包含有关反复头痛的信息，如类型、病因和触发因素)。这两个小组将在一个月的时间里完成各自计划中的模块。然后将在治疗后一个月以及治疗后三个月、六个月和十二个月的随访中继续收集依赖措施。主要研究结果将是头痛的频率、持续时间和强度，通过每天的头痛日记来衡量。次要终点将包括与头痛相关的残疾结果和生活质量。

DESCRIPTION (provided by applicant): Recurrent pediatric headache is a chronic pain syndrome affecting more than two million American children and often resulting in significant functional disability and debilitation. Moreover, this syndrome represents a substantial cost to the patient's family and the health care system. The goal of the present study is to evaluate the efficacy of a new cost-effective approach to the treatment of recurrent pediatric headache that allows children to learn how to self-manage their headaches via a CD-ROM program (called "Headstrong TM"). This grant proposal is being submitted in response to PA-01-115, which called for research seeking to identify and refine innovative and effective treatment strategies for specific pain conditions. A randomized trial will be used to evaluate the effectiveness of the Headstrong TM intervention. One-hundred and eight (108) pediatric patients, ages 7-12 years, with a diagnosed recurrent migraine, muscle-contraction, or chronic daily headache syndrome will be enrolled in the study. After enrollment, each patient's baseline headache frequency, duration, and intensity will be assessed for one month using headache diaries. During this one-month baseline period, we will also collect data to examine headache-related disability and health related quality of life. After baseline, patients will be randomly assigned to the standard medical care plus Headstrong TM intervention or the standard medical care plus Education condition (also a CD-ROM program with information about recurrent headaches, such as types, etiology, and triggers). Both groups will work through modules in their respective programs over the course of one month. Dependent measures will then continue to be collected at one-month post-treatment and three-, six-, and twelve-month post-treatment follow-up. The primary study outcome will be headache frequency, duration, and intensity as measured by daily headache diaries. Secondary endpoints will include headache-related disability outcomes and quality of life.