Asthma
Conditions
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 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.
Interventions
BEHAVIORALProject ASPIRE Home-Based Family Intervention
Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months
BEHAVIORALProject ASPIRE Enhanced Treatment As Usual
Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score on the Family Asthma Management System Scale (FAMSS) | 4 months from baseline | 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. |
| Metered Dose Inhaler Checklist (MDIC) | 4 months, 10 months | Observational rating scale assessing MDI/spacer technique |
| 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
| Measure | Time frame |
|---|---|
| Parenting Stress Index - SF (PSI-SF) | 4 months, 10 months |
| Brief Symptom Inventory (BSI) | 4 months, 10 months |
Countries
United States
Participant flow
Recruitment details
Families were recruited from an urban hospital and a residential camp for children with asthma. Initial eligibility criteria : (a) residence in one of two urban counties, (b) child age 8 to 13, (c) Medicaid or State Children's Health Insurance Program, (d) current prescription of a daily controller agent, and (e) poorly controlled asthma.
Pre-assignment details
Caregivers of children meeting initial eligibility criteria were interviewed briefly by phone; those answering affirmatively to either of two stress questions were invited to participate in a Screening Assessment. Caregivers with an elevated score on a stress measure were invited to participate in the trial.
Participants by arm
| Arm | Count |
|---|---|
| 1: Home-based Family Intervention Home-based family intervention
Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months | 21 |
| 2: Enhanced Treatment As Usual Enhanced Treatment As Usual (1 home visit)
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 | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | 2: Enhanced Treatment As Usual | Total | 1: Home-based Family Intervention |
|---|---|---|---|
| Age, Continuous | 10.6 years STANDARD_DEVIATION 1.9 | 10.5 years STANDARD_DEVIATION 1.6 | 10.4 years STANDARD_DEVIATION 1.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 40 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 15 Participants | 6 Participants |
| Sex: Female, Male Male | 11 Participants | 26 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 20 |
| serious Total, serious adverse events | 0 / 23 | 0 / 20 |
Outcome results
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
Time frame: 4 months, 10 months
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.
Time frame: 4 months from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1: Home-based Family Intervention | Mean Score on the Family Asthma Management System Scale (FAMSS) | 4.9 units on a scale | Standard Error 0.293 |
| 2: Enhanced Treatment As Usual | Mean Score on the Family Asthma Management System Scale (FAMSS) | 4.1 units on a scale | Standard Error 0.3 |
p-value: 0.23Regression, Linear
Primary
Metered Dose Inhaler Checklist (MDIC)
Observational rating scale assessing MDI/spacer technique
Time frame: 4 months, 10 months
Secondary
Brief Symptom Inventory (BSI)
Time frame: 4 months, 10 months
Secondary
Parenting Stress Index - SF (PSI-SF)
Time frame: 4 months, 10 months