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

Project ASPIRE: Improving Pediatric Asthma Management for Urban Families

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University School of Medicine
    • Smyrna, Georgia, United States, 30080
      • American Lung Association - Southeast Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1: Home-based family intervention; Home-based family intervention	Behavioral: 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: 2: ETAU; Enhanced Treatment As Usual (1 home visit)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Score on the Family Asthma Management System Scale (FAMSS)	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.	4 months from baseline
Metered Dose Inhaler Checklist (MDIC)	Observational rating scale assessing MDI/spacer technique	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		4 months, 10 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Parenting Stress Index - SF (PSI-SF)	4 months, 10 months
Brief Symptom Inventory (BSI)	4 months, 10 months

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Marianne P. Celano, PhD, Emory University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: October 3, 2006
• First Submitted That Met QC Criteria: October 3, 2006
• First Posted (Estimate): October 6, 2006

Study Record Updates

• Last Update Posted (Estimate): July 28, 2014
• Last Update Submitted That Met QC Criteria: July 3, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 014-2006 (Other Identifier: Emory IRB); R21HL083877 (U.S. NIH Grant/Contract)