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
2 other identifiers
interventional
43
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 asthma
Started Jan 2007
Typical duration for phase_2 asthma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2006
CompletedFirst Posted
Study publicly available on registry
October 6, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
July 28, 2014
CompletedJuly 28, 2014
July 1, 2014
2.2 years
October 3, 2006
May 20, 2014
July 3, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Parenting Stress Index - SF (PSI-SF)
4 months, 10 months
Brief Symptom Inventory (BSI)
4 months, 10 months
Study Arms (2)
1: Home-based family intervention
EXPERIMENTALHome-based family intervention
2: ETAU
ACTIVE COMPARATOREnhanced Treatment As Usual (1 home visit)
Interventions
Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months
Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Emory University School of Medicine
Atlanta, Georgia, 30303, United States
American Lung Association - Southeast Division
Smyrna, Georgia, 30080, United States
Related 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.
PMID: 22353006RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marianne Celano, PhD, ABPP
- Organization
- Emory University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Marianne P. Celano, PhD
Emory University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 3, 2006
First Posted
October 6, 2006
Study Start
January 1, 2007
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
July 28, 2014
Results First Posted
July 28, 2014
Record last verified: 2014-07