Family Approach to Managing Asthma in Early Teens
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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New York
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New York、New York、美国、10016
- New York University School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria for Youth:
- Prior diagnosis of asthma from a medical provider
- Asthma symptoms an average of 3 times per month during the 12 months prior to study entry OR less frequent symptoms but having 1 or more urgent visits to a doctor/emergency room or hospitalization for asthma during the 12 months prior to study entry
- Use of prescribed asthma medication in the 12 months prior to study entry
Inclusion Criteria for Families:
- Child and participating parent must live together
Exclusion Criteria for Youth:
- Co-morbidity that might affect lung function, such as cystic fibrosis or sickle cell anemia
- Highly specialized developmental or learning needs (e.g., Down's syndrome, mental retardation, severe ADHD)
- Major psychiatric illness
Exclusion Criteria for Families:
- Foster parents and their children
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Behavioral Intervention: Asthma: It's a Family Affair
Separate student and parent intervention groups.
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Intervention families will receive a comprehensive program with two complementary components: (1) a school-based intervention to empower middle school students to manage their asthma and (2) parent training to teach their caregivers childrearing skills that support the youth's growing autonomy and need to self-manage their disease.
The student component is comprised of 6, 60 minute group workshops; the caregiver component consists of 5, 90-minute group workshops.
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有源比较器：Behavioral Control Group
Students and parents participate in an education only control group
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Caregivers assigned to the Asthma and Stress Comparator group will receive a single educational workshop focusing on the developmental changes adolescents experience, how these changes may cause stress, and ways to cope with stress.
The children will also participate in a single school-based session on similar topics.
Both caregivers and students will learn basic asthma facts.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Symptom severity
大体时间：baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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quality of life
大体时间：Baseline, and immediate, 6-months and 12-months post-intervention
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Baseline, and immediate, 6-months and 12-months post-intervention
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asthma management skills
大体时间：Baseline, and immediate, 6-months and 12-months post-intervention
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Baseline, and immediate, 6-months and 12-months post-intervention
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Urgent health care utilization
大体时间：baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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days with activity restriction
大体时间：baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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parent-child interactions
大体时间：Baseline, and immediate, 6-months and 12-months post-intervention
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Baseline, and immediate, 6-months and 12-months post-intervention
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合作者和调查者
调查人员
- 首席研究员：Jean-Marie Bruzzese, PhD、NYU Langone Health
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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