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| ID | Type | Description | Link |
|---|---|---|---|
| R21HL083877 | U.S. NIH Grant/Contract | View source | |
| 014-2006 | Other Identifier | Emory IRB |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Home-based family intervention | Experimental | Home-based family intervention |
|
| 2: ETAU | Active Comparator | Enhanced Treatment As Usual (1 home visit) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Project ASPIRE Home-Based Family Intervention | Behavioral | Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Parenting Stress Index - SF (PSI-SF) | 4 months, 10 months | |
| Brief Symptom Inventory (BSI) | 4 months, 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne P. Celano, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University School of Medicine | Atlanta | Georgia | 30303 | United States | ||
| American Lung Association - Southeast Division |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22353006 | Result | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 2: Enhanced Treatment As Usual |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | units on a scale | 4 months from baseline |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marianne Celano, PhD, ABPP | Emory University School of Medicine | 404-778-1536 | mcelano@emory.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Project ASPIRE Enhanced Treatment As Usual | Behavioral | Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist |
|
| Smyrna |
| Georgia |
| 30080 |
| United States |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
|
| Primary | Metered Dose Inhaler Checklist (MDIC) | Observational rating scale assessing MDI/spacer technique | Not Posted | 4 months, 10 months |
| 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 | Not Posted | 4 months, 10 months |
| Secondary | Parenting Stress Index - SF (PSI-SF) | Not Posted | 4 months, 10 months |
| Secondary | Brief Symptom Inventory (BSI) | Not Posted | 4 months, 10 months |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 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 | 0 | 20 | 0 | 20 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |