This trial is active, not recruiting.

Condition asthma
Treatments project aspire home-based family intervention, project aspire enhanced treatment as usual
Phase phase 2
Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Start date January 2007
End date April 2009
Trial size 50 participants
Trial identifier NCT00384813, 412, HL083877-01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Home-based family intervention
project aspire home-based family intervention
Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months
(Active Comparator)
Enhanced Treatment As Usual (1 home visit)
project aspire enhanced treatment as usual
Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist

Primary Outcomes

Asthma self-management, as determined by family interviews, child's observed technique with metered dose inhaler (MDI)/spacer, and child's exposure to environmental tobacco smoke (ETS)
time frame: 4 months, 10 months
Asthma morbidity, as determined by number of asthma symptom days, number of school days missed due to asthma, and number of emergency department visits for acute asthma
time frame: 4 months, 10 months
Family functioning
time frame: 4 months, 10 months
Caregiver stress
time frame: 4 months, 10 months

Secondary Outcomes

Charges for asthma-related health care utilization
time frame: 4 months, 6 months

Eligibility Criteria

Male or female participants from 8 years up to 13 years old.

Inclusion Criteria: - Clinical diagnosis of persistent asthma - Poorly controlled asthma, as determined by emergency department visit, hospitalization, or steroid burst in the year prior to study entry - Primary caregiver is under stress, as determined by a significantly elevated score on measures of stress - Receives Medicaid or participates in Medicaid HMO - Resides in the Atlanta metropolitan area Exclusion Criteria: - Nonatopic, nonpsychiatric illness that requires daily medication - Diagnosis of asthma in the year prior to study entry - Homeless - Caregiver is unable to complete study screening process - Caregiver does not speak English

Additional Information

Official title Project ASPIRE: Improving Pediatric Asthma Management for Urban Families
Principal investigator Marianne P. Celano, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI).