Asthma Clinical Trial
Official title:
Parent-Youth Teamwork in Pediatric Asthma Management
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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