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临床试验/NCT00166582
NCT00166582已完成2 期

Parent-Youth Teamwork in Pediatric Asthma Management

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2002年4月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
60
试验地点
4
主要终点
medication adherence, parental involvement , perceived parent-adolescent conflict, associated health outcome

研究概览

简要总结

The purpose of this research study is to examine the effectiveness of a parent-youth teamwork treatment and an asthma education treatment in helping children use their asthma medicines correctly. We also want to learn about how these treatments affect parental involvement in asthma care, parent and youth relationships, and children's health care.

详细描述

Noncompliance with medication is a prevalent problem for pediatric asthma patients, particularly for pre-adolescents and adolescents. Families reportedly struggle with the transition of expecting adolescents to assume more independence and responsibility in asthma management. Parent-child collaborative management of pediatric chronic illness regimens has been related to better adherence to medical regimens and improved health outcome. This study has four aims. The first aim is to investigate the effectiveness of a low-intensity, behavioral intervention aimed at promoting parental involvement in children's asthma management, particularly in improving medication adherence. The second aim is to examine how the role of parental involvement changes across time and participation in a 5-month study. A third aim is to determine whether parent-adolescent conflict is changed by the intervention. The fourth aim is to evaluate whether participation in the treatment program is associated with improved health status (e.g., improved pulmonary function test results).

Established asthma patients (ages 9-15) will be randomly assigned to one of three groups: Treatment Intervention (TI), Asthma Education (AE), and Standard Care (SC). The TI and AE groups will receive four 30-minute treatment sessions every two weeks. The TI intervention will consist of strategies aimed at promoting parent-youth management in asthma management. The AE group will receive structured reviews of asthma educational materials typically given to asthma patients. SC participants will have no contact with researchers beyond that necessary to gather data. Data will be collected from all participants every two weeks for the first 8-weeks of study involvement and also about 3-months after the final treatment session. Outcome data will include objective measures of medication adherence, parental involvement in asthma, and health outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
9 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patient has been diagnosed with asthma for at least 6 months
  • patient can be managed appropriately on study medications as determined by the attending physician

排除标准

  • patient shows evidence of neurological or significant cognitive impairment

结局指标

主要结局

medication adherence, parental involvement , perceived parent-adolescent conflict, associated health outcome

次要结局

未报告次要终点

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

研究点 (4)

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Parent-Youth Teamwork in Pediatric Asthma Management | 临床试验