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

Asthma Clinical Trial

— ASPIRE  

Official title:

Project ASPIRE: Improving Pediatric Asthma Management for Urban Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384813
• Other study ID #: 014-2006
• Secondary ID: R21HL083877014-2
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2006
• Last updated: July 3, 2014
• Start date: January 2007
• Est. completion date: April 2009

Study information

• Verified date: July 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 13 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

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
• 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

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	American Lung Association - Southeast Division	Smyrna	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Metered Dose Inhaler Checklist (MDIC)	Observational rating scale assessing MDI/spacer technique	4 months, 10 months	No
Primary	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	No
Secondary	Parenting Stress Index - SF (PSI-SF)		4 months, 10 months	No
Secondary	Brief Symptom Inventory (BSI)		4 months, 10 months	No