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临床试验/NCT00241852
NCT00241852已完成3 期

Family Approach to Managing Asthma in Early Teens

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 392 人开始时间: 2005年5月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
392
试验地点
2
主要终点
Symptom severity

研究概览

简要总结

The purpose of this study is to test two asthma management programs: (a) a school-based curriculum to empower middle school students to manage their asthma and (b) a parent training curriculum to teach childrearing skills that support the youths' growing autonomy and need to self-manage their disease.

详细描述

BACKGROUND:

Asthma is a public health problem with its prevalence and morbidity being significant in 11- to 14-year olds, particularly among ethnic minorities. Despite this, little has been done to intervene with this age group. This is surprising considering the success of asthma education programs for younger children. In addition, there are no reports of parenting training to help families manage asthma despite the significant influence parenting strategies have on the management of chronic illnesses.

DESIGN NARRATIVE:

The overall goal of this study is to test the efficacy of a program with two complementary components: (a) a school-based curriculum to empower middle school students to manage their asthma and (b) a parent training curriculum to teach childrearing skills that support the youths' growing autonomy and need to self-manage their disease. The specific aims are: (1) to implement screening to identify 6th - 8th grade students with persistent asthma; and (2) to provide health education and parent training to help children and parents manage asthma more effectively. The student program is based on Coping with Asthma at Home and at School, a successful program developed in Holland. The parent program is an adaptation of Thriving Teens, an effective parent training program developed by the investigators. Participants in this randomized control trial will be 384 children with asthma and their caregivers from 16 New York City public schools serving low-income, ethnic minorities. It is hypothesized that students randomized to the intervention will have, relative to controls, improvements in three primary outcomes: (1) reduced symptom severity; (2) improved quality of life; and (3) better asthma management skills. Also, when compared to controls, intervention students will show improvement in the following secondary outcomes: (4) urgent health care utilization; (5) days with activity restriction; and (6) parent-child interactions. Caregivers and children will complete comprehensive surveys assessing these outcomes at baseline, and immediately and 6- and 12-months after the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
11 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Symptom severity

时间窗: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention

quality of life

时间窗: Baseline, and immediate, 6-months and 12-months post-intervention

asthma management skills

时间窗: Baseline, and immediate, 6-months and 12-months post-intervention

次要结局

  • parent-child interactions(Baseline, and immediate, 6-months and 12-months post-intervention)
  • Urgent health care utilization(baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention)
  • days with activity restriction(baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Marie Bruzzese

Associate Professor

NYU Langone Health

研究点 (2)

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