Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384813
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
2006-10-03
Brief Title:
Family-Focused Stress-Reduction Program to Improve the Health Care of Urban Children With Asthma
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Project ASPIRE Improving Pediatric Asthma Management for Urban Families
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASPIRE
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 childs doctors 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 childs inhaler use tobacco exposure levels will be measured with a urine test and family functioning and stress levels will be assessed with questionnaires
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 childs doctors 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 childs inhaler use tobacco exposure levels will be measured with a urine test and family functioning and stress levels will be assessed with questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21HL083877 | NIH | None | None |
| 014-2006 | OTHER | Emory IRB | httpsreporternihgovquickSearchR21HL083877 |