Family Approach to Managing Asthma in Early Teens
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 1
- 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
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Behavioral Intervention: Asthma: It's a Family Affair
Separate student and parent intervention groups.
干预措施: Asthma: It's a Family Affair! (Behavioral)
Behavioral Control Group
Students and parents participate in an education only control group
干预措施: Asthma and Stress Comparator (Behavioral)
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
Jean-Marie Bruzzese
Associate Professor
NYU Langone Health