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

Emory University logo

Emory University

Status and phase

Completed
Phase 2

Conditions

Asthma

Treatments

Behavioral: Project ASPIRE Enhanced Treatment As Usual
Behavioral: Project ASPIRE Home-Based Family Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00384813
R21HL083877 (U.S. NIH Grant/Contract)
014-2006 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

8 to 13 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

43 participants in 2 patient groups

1: Home-based family intervention
Experimental group
Description:
Home-based family intervention
Treatment:
Behavioral: Project ASPIRE Home-Based Family Intervention
2: ETAU
Active Comparator group
Description:
Enhanced Treatment As Usual (1 home visit)
Treatment:
Behavioral: Project ASPIRE Enhanced Treatment As Usual

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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