Asthma Clinical Trial
Official title:
Project ASPIRE: Improving Pediatric Asthma Management for Urban Families
Stress and anxiety can negatively affect children with asthma. Reducing the stress of asthmatic children and their families may lead to improved asthma care and fewer asthma symptoms in the children. The purpose of this study is to develop and evaluate a family-focused asthma education program aimed at reducing stress levels and improving asthma care for urban children with asthma.
Asthma is a serious, chronic illness that affects 9 million children in the United States.
Common asthma symptoms include wheezing, shortness of breath, chest tightness, and coughing.
Asthma attacks can be triggered by a variety of irritants, including mold, pollen, tobacco
smoke, or allergies. Stress can also cause asthma attacks, and children who experience high
levels of stress and anxiety tend to have poor asthma management skills and health outcomes.
Additionally, family stress can affect the ability of families and caregivers to provide
adequate care to children with asthma. Currently, few asthma education programs are aimed at
helping both children and parents manage stress. The purpose of this study is to evaluate
the effectiveness of a stress-reduction family intervention on improving health outcomes in
asthmatic children.
Study researchers will first conduct focus groups with children who have asthma, their
parents, and community health organizations to identify barriers to effective asthma
management and sources of stress for caregivers; a family-focused intervention will then be
developed. Fifty families with an asthmatic child will be enrolled and randomly assigned to
one of two groups. Group 1 participants will partake in four to six home-based, family
educational sessions over a 4-month period. Sessions will focus on asthma education and
stress management techniques for the entire family. One of these sessions may take place at
the child's doctor's office as a way to focus on improving parent-doctor communication.
Group 2 participants will partake in a single home-based asthma education session. Study
visits for all participants will occur at baseline, Month 4, and 6 months post-intervention.
At these timepoints, asthma self-management will be assessed through family interviews and
observation of the child's inhaler use; tobacco exposure levels will be measured with a
urine test; and family functioning and stress levels will be assessed with questionnaires.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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