Clinical trial NCT00384813: Family-Focused, Stress-Reduction Program to Improve the Health Care of Urban Children With Asthma
Official title: Project ASPIRE: Improving Pediatric Asthma Management for Urban Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-10-06
Enrollment: 43
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Score on the Family Asthma Management System Scale (FAMSS)
timeFrame: 4 months from baseline
measure: Metered Dose Inhaler Checklist (MDIC)
timeFrame: 4 months, 10 months
measure: 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
timeFrame: 4 months, 10 months
Secondary outcomes:
measure: Parenting Stress Index - SF (PSI-SF)
timeFrame: 4 months, 10 months
measure: Brief Symptom Inventory (BSI)
timeFrame: 4 months, 10 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Smyrna
country: United States
facility: American Lung Association - Southeast Division
state: Georgia
Study officials:
affiliation: Emory University
name: Marianne P. Celano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Celano MP, Holsey CN, Kobrynski LJ. Home-based family intervention for low-income children with asthma: a randomized controlled pilot study. J Fam Psychol. 2012 Apr;26(2):171-8. doi: 10.1037/a0027218. Epub 2012 Feb 20.