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临床试验/NCT00916240
NCT00916240已完成不适用

Multisystemic Therapy to Reduce Health Disparities in Adolescents With Asthma

National Heart, Lung, and Blood Institute (NHLBI)1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2008年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
1
主要终点
Pulmonary functioning (FEV-1, FVC)

研究概览

简要总结

Asthma is a chronic lung disease that inflames and narrows the airways. Symptoms can include recurring periods of wheezing, chest tightness, shortness of breath, and coughing. Minority, inner city teens are at increased risk for complications from the disease, possibly because of poor illness management. The purpose of this study is to test the effectiveness of Multisystemic Therapy (MST)-an intensive, home- and community-based psychotherapy-for improving asthma management and overall health and for reducing healthcare costs for inner city African American teens with asthma.

详细描述

Although rates of childhood asthma are increasing worldwide, more alarming is the disproportionate rise in rates of asthma among urban, disadvantaged, minority children. Inner city children, particularly adolescents, also appear to be most at risk for morbidity, mortality, and emergency department visits as a result of asthma. This may be caused by poor illness management.

Because of the multiple factors that affect whether or not a family is able to adequately manage a youth's asthma, educational interventions alone are typically insufficient to reduce morbidity and healthcare utilization, particularly in high-risk urban populations. As a result, more intensive, multi-component interventions are necessary to improve asthma management and outcomes for those youth at highest risk. MST is an innovative, flexible, home- and community-based family therapy that has been shown to improve health outcomes in urban children and adolescents with other chronic medical conditions such as type 1 diabetes and HIV infection. The purpose of this study is to determine the effectiveness of MST in improving health outcomes and reducing healthcare costs in high-risk urban adolescents with moderate to severe persistent asthma.

Participants will include high-risk African-American adolescents with moderate to severe asthma. High-risk youth are defined as those with one or more hospitalizations for asthma treatment in the previous 12 months. At a baseline hospital visit, participants will complete questionnaires and an interview, both of which will focus on the participant's family and asthma history. Participants will also have the option of having the study personnel visit their home instead. Participants will then be randomly assigned to receive either MST plus standard multidisciplinary specialty care or standard multidisciplinary care alone.

Participants assigned to MST will attend psychological treatment sessions in their homes for about 6 months. Treatment sessions will be attended by both children and parents, occur at a time designated by the participants, and last about 1 hour. Participants will also complete questionnaires about their interactions with the therapist and their satisfaction with treatment.

Participants assigned to standard multidisciplinary specialty care alone will receive weekly home-based, supportive family counseling for about 6 months. The treatment will provide emotional support to the family regarding asthma, help the family spot problems in asthma care, and address specific support that may help them with asthma management. Counseling sessions will last about 45 minutes.

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
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Moderate to severe persistent asthma
  • •African American
  • •One or more hospitalizations for asthma in the last 12 months

排除标准

  • •No exclusions will be made due to co-morbid mental health problems (i.e., attention deficit hyperactivity disorder [ADHD], conduct disorder, depression, anxiety disorder), with the exception of thought disorder (i.e. schizophrenia, autism), suicidality, or mental retardation

研究组 & 干预措施

1

Experimental

Participants will receive Multisystemic Therapy (MST).

干预措施: Multisystemic Therapy (Behavioral)

2

Active Comparator

Participants will receive home-based, non-directive family support.

干预措施: Home-based, Non-Directive Family Support (Behavioral)

结局指标

主要结局

Pulmonary functioning (FEV-1, FVC)

时间窗: Measured at study entry and Months 7 (post treatment) and 12

Hospital and emergency department utilization (for asthma exacerbation)

时间窗: Measured at study entry and Months 7 (post treatment) and 12

次要结局

  • Identification of mediators and moderators of MST treatment effects, e.g., individual adolescent factors (asthma knowledge/skill, mental health); family factors (family routines and relationships), etc.(Measured at study entry and Months 7 (post treatment) and 12)

研究者

研究点 (1)

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