Family-Focused, Stress-Reduction Program to Improve the Health Care of Urban Children With Asthma (ASPIRE)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Project ASPIRE Home-Based Family Intervention
Project ASPIRE Enhanced Treatment As Usual
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
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
Sites / Locations
- Emory University School of Medicine
- American Lung Association - Southeast Division
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1: Home-based family intervention
2: ETAU
Arm Description
Home-based family intervention
Enhanced Treatment As Usual (1 home visit)
Outcomes
Primary Outcome Measures
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.
Metered Dose Inhaler Checklist (MDIC)
Observational rating scale assessing MDI/spacer technique
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
Secondary Outcome Measures
Parenting Stress Index - SF (PSI-SF)
Brief Symptom Inventory (BSI)
Full Information
NCT ID
NCT00384813
First Posted
October 3, 2006
Last Updated
July 3, 2014
Sponsor
Emory University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00384813
Brief Title
Family-Focused, Stress-Reduction Program to Improve the Health Care of Urban Children With Asthma
Acronym
ASPIRE
Official Title
Project ASPIRE: Improving Pediatric Asthma Management for Urban Families
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Home-based family intervention
Arm Type
Experimental
Arm Description
Home-based family intervention
Arm Title
2: ETAU
Arm Type
Active Comparator
Arm Description
Enhanced Treatment As Usual (1 home visit)
Intervention Type
Behavioral
Intervention Name(s)
Project ASPIRE Home-Based Family Intervention
Intervention Description
Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months
Intervention Type
Behavioral
Intervention Name(s)
Project ASPIRE Enhanced Treatment As Usual
Intervention Description
Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist
Primary Outcome Measure Information:
Title
Mean Score on the Family Asthma Management System Scale (FAMSS)
Description
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.
Time Frame
4 months from baseline
Title
Metered Dose Inhaler Checklist (MDIC)
Description
Observational rating scale assessing MDI/spacer technique
Time Frame
4 months, 10 months
Title
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
Time Frame
4 months, 10 months
Secondary Outcome Measure Information:
Title
Parenting Stress Index - SF (PSI-SF)
Time Frame
4 months, 10 months
Title
Brief Symptom Inventory (BSI)
Time Frame
4 months, 10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne P. Celano, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
American Lung Association - Southeast Division
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22353006
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.
Results Reference
result
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Family-Focused, Stress-Reduction Program to Improve the Health Care of Urban Children With Asthma
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