AsthmaPhase 2ASPIRENCT00384813
Family-Focused, Stress-Reduction Program to Improve the Health Care of Urban Children With Asthma
A Phase 2 study testing Project ASPIRE Home-Based Family Intervention and Project ASPIRE Enhanced Treatment As Usual in people with Asthma, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Asthma
- What is being tested?
- Project ASPIRE Home-Based Family Intervention and Project ASPIRE Enhanced Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to Apr 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University School of Medicine
Atlanta, Georgia, 30303
American Lung Association - Southeast Division
Smyrna, Georgia, 30080
About this study
Official title: Project ASPIRE: Improving Pediatric Asthma Management for Urban Families
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Project ASPIRE Home-Based Family Intervention, Project ASPIRE Enhanced Treatment As Usual
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project ASPIRE Home-Based Family InterventionBehavioural
Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months
Project ASPIRE Enhanced Treatment As UsualBehavioural
Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist
| Study group | Role | What they receive |
|---|---|---|
| 1: Home-based family intervention | Experimental | Home-based family intervention Receives: Behavioral: Project ASPIRE Home-Based Family Intervention |
| 2: ETAU | Active comparator | Enhanced Treatment As Usual (1 home visit) Receives: Behavioral: Project ASPIRE Enhanced Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months from baseline
Metered Dose Inhaler Checklist (MDIC)
Observational rating scale assessing MDI/spacer technique
Measured: 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
Measured: 4 months, 10 months
Secondary outcomes (2)
Parenting Stress Index - SF (PSI-SF)
Measured: 4 months, 10 months
Brief Symptom Inventory (BSI)
Measured: 4 months, 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startJan 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Marianne Celano, Emory University
- Investigators
- Marianne P. Celano, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384813
- Sponsor's protocol ID
- 014-2006
- Other IDs
- R21HL083877, 014-2006
- Acronym
- ASPIRE
- Status last verified
- Jul 2014
- First submitted
- 3 Oct 2006
- Last updated
- 28 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22353006
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project ASPIRE: Improving Pediatric Asthma Management for Urban Families
- ClinicalTrials.gov ID
- NCT00384813
- Acronym / sponsor ID
- ASPIRE / 014-2006
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 6 Oct 2006 (estimated)
- Results
- Posted 28 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Home-based family intervention | Experimental | Behavioral: Project ASPIRE Home-Based Family InterventionHome-based family intervention |
| 2: ETAU | Active comparator | Behavioral: Project ASPIRE Enhanced Treatment As UsualEnhanced Treatment As Usual (1 home visit) |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project ASPIRE Home-Based Family InterventionHome-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months | Behavioural | 1: Home-based family intervention |
| Project ASPIRE Enhanced Treatment As UsualPsychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist | Behavioural | 2: ETAU |
Primary outcome
Mean Score on the Family Asthma Management System Scale (FAMSS)
Time frame: 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)
Time frame: 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
Time frame: 4 months, 10 months
2 secondary outcomes
Parenting Stress Index - SF (PSI-SF)
Time frame: 4 months, 10 months
Brief Symptom Inventory (BSI)
Time frame: 4 months, 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22353006Celano 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne P. Celano, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Project ASPIRE Home-Based Family Intervention and Project ASPIRE Enhanced Treatment As Usual in people with Asthma, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score on the Family Asthma Management System Scale (FAMSS) (time frame: 4 months from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00384813, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2014.