Family-Focused, Stress-Reduction Program to Improve the Health Care of Urban Children With Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Behavioral: Project ASPIRE Home-Based Family Intervention; Behavioral: Project ASPIRE Enhanced Treatment As Usual

• Registration Number: NCT00384813
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2006-10-03
• Study First Submitted QC: 2006-10-03
• Study First Posted: 2006-10-06
• Study Start: 2007-01
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2014-05-20
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-03
• Last Update Submitted: 2014-07-03
• Results First Posted: 2014-07-28
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Home-based family intervention	Project ASPIRE Home-Based Family Intervention	Home-based family intervention
2: ETAU	Project ASPIRE Enhanced Treatment As Usual	Enhanced Treatment As Usual (1 home visit)

Primary Outcome Measures

Name	Time	Method
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	4 months, 10 months
Mean Score on the Family Asthma Management System Scale (FAMSS)	4 months from baseline	Family Asthma Management System Scale is semi-structured clinical interview that includes open-ended questions assessing family management of pediatric asthma. The interview is recorded and rated using a standard manual on seven core subscales and two optional subscales.The interview is recorded and rated on seven to nine 9-point subscales that tap the various domains of asthma management, with higher scores indicating better management (1 being the worse asthma management and 9 being the best asthma management). Mean of all of the subscales used to compute a total score.
Metered Dose Inhaler Checklist (MDIC)	4 months, 10 months	Observational rating scale assessing MDI/spacer technique

Secondary Outcome Measures

Name	Time	Method
Parenting Stress Index - SF (PSI-SF)	4 months, 10 months
Brief Symptom Inventory (BSI)	4 months, 10 months

Trial Locations

Locations (2)

American Lung Association - Southeast Division; 🇺🇸 Smyrna, Georgia, United States

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States