Phase 2
Completed N=43
Family-Focused, Stress-Reduction Program to Improve the Health Care of Urban Children With Asthma
Source: ClinicalTrials.gov NCT00384813 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Mean Score on the Family Asthma Management System Scale (FAMSS) — 4.9; 4.1 units on a scale — p=0.23
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.
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) |
— | — |
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
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. Informational only — not medical advice.