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

NCT ID: NCT00384813

Last Updated: 2014-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-04-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1: Home-based family intervention

Home-based family intervention

Group Type: EXPERIMENTAL

Project ASPIRE Home-Based Family Intervention

Intervention Type: BEHAVIORAL

Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months

2: ETAU

Enhanced Treatment As Usual (1 home visit)

Group Type: ACTIVE_COMPARATOR

Project ASPIRE Enhanced Treatment As Usual

Intervention Type: BEHAVIORAL

Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist

Interventions

Project ASPIRE Home-Based Family Intervention

Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Marianne Celano

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marianne P. Celano, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University School of Medicine

Atlanta, Georgia, United States

American Lung Association - Southeast Division

Smyrna, Georgia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22353006 (View on PubMed)

Other Identifiers

R21HL083877

Identifier Type: NIH

Identifier Source: secondary_id

View Link

014-2006

Identifier Type: OTHER

Identifier Source: secondary_id

014-2006

Identifier Type: -

Identifier Source: org_study_id