Phase 2 N=43 Randomized Single-blind Treatment

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

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00384813 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcome: Primary: Mean Score on the Family Asthma Management System Scale (FAMSS) — 4.9; 4.1 units on a scale — p=0.23

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Project ASPIRE Home-Based Family Intervention (Behavioral); Project ASPIRE Enhanced Treatment As Usual (Behavioral)
Age: Pediatric · 8+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Score on the Family Asthma Management System Scale (FAMSS)	4.9; 4.1	0.23
PRIMARY Metered Dose Inhaler Checklist (MDIC)	—	—
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	—	—
SECONDARY Parenting Stress Index - SF (PSI-SF)	—	—
SECONDARY Brief Symptom Inventory (BSI)	—	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00384813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.