AsthmaNCT02374138
Breathe With Ease: A Unique Approach to Managing Stress (BEAMS)
A study testing Parental stress management in people with Asthma, run by Stephen J. Teach, MD, MPH at 1 site in United States.
Trial summary
Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Parental stress management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to May 2017
- Phase
- Interventional
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- self-identify as African-American
- both the legal guardian and primary asthma caregiver of an eligible child.
- parent-identified as African-American
- age 4-12 years inclusive at recruitment
- physician diagnosis of persistent asthma
- publicly financed insurance
Who cannot join
- unable or unwilling to sign informed consent document
- exclusionary psychiatric condition, including but not limited to psychosis, based on the screening form at recruitment
- enrolled in another asthma research study.
- chronic medical condition (other than asthma) including but not limited to diabetes, sickle cell disease, heart disease, lung disease or neurological disorder.
- In addition, the PI may choose to not include a participant if he does not believe it is in the family's best interest to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Improving Asthma Outcomes Through Stress Management
Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children.
A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes.
Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.
Read the detailed description
Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children.
A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes.
Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.
We will conduct a single blind, prospective randomized controlled trial comparing the IMPACT DC Asthma Clinic's existing intervention of guideline-based clinical care, education, and short-term care coordination (usual care) to usual care plus parental stress management in a cohort of up to 200 parent-child dyads of AA youth aged 4-12 years.
- Conditions
- Asthma
- Being tested
- Parental stress management, Usual Care
- Keywords
- psychosocial stress
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental stress managementBehavioural
The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."
Usual CareOther
IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Receives: Other: Usual Care |
| Intervention | Experimental | Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Receives: Behavioral: Parental stress management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom-free Days in the Last 14 Days
Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
Measured: Repeated Measures at 6 months (3 month data collected to allow for repeated measures)
Secondary outcomes (19)
Asthma Morbidity - Nighttime Asthma Symptoms
Nights of asthma symptoms in prior 14d
Measured: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Asthma Severity and Control
Measured: Repeated Measures at 3, 6, and 12 months
Asthma Medication Adherence
Reported use of inhaled corticosteroids and LTRA in past two days
Measured: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Health Care Utilization - Emergency Department Visits for Asthma
Health care utilization - emergency department visits for asthma over six month and twelve month follow up periods. Reported as those documented in the electronic medical record of Children's National Health System plus parent report of visits elsewhere
Measured: 12 months after enrollment
Asthma Exacerbations - Courses of Systemic Steroids
Courses of systemic steroids over 12m follow up period
Measured: Assessed at 6m and 12m following enrollment
Parental Stress
Score on Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 questions and is a measure of the degree to which situations in one's life are appraised as stressful. Scores range from 0 - 40, with higher scores indicating a higher level of perceived stress.
Measured: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Parental Depression
Score on Center for Epidemiologic Studies Depression Scale (CES-D - 10). The CESD-10 scale screens for depressive symptoms. Scores range from 0-30, with higher scores indicating a higher degree of depressive symptoms.
Measured: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Child Anxiety
PROMIS Parent Proxy Anxiety. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.
Measured: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Child Depression
PROMIS Parent Proxy Depressive Symptoms is a parent-report assessment of child depression. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.
Measured: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Caregiver Quality of Life
Caregiver quality of life score, assessed by modified Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ). The measure had five response options, with scores ranging from 13-65 and higher scores meaning better quality of life. No subscales were analyzed.
Measured: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Number of Participants With AEs and SAEs
Safety data: Number of Participants with AEs and SAEs
Measured: 12m follow up period
Economic Outcomes
Analysis of costs of care in both groups
Measured: 12m follow-up period
Caregiver Smoking Behavior
parent report of cigarettes smoked per day
Measured: Repeated Measures at 6 and 12 months
Coping Strategies
Brief COPE
Measured: Repeated measures at 12m FU (6m data used for repeated measures)
Mindfulness
Interpersonal Mindfulness in Parenting
Measured: Repeated Measures at 6 and 12 months
Parental Resilience
Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.
Measured: Repeated Measures at 6 and 12 months
Exacerbations - Hospital Admissions
Number of participants with hospital admissions due to exacerbations
Measured: Assessed at 6m and 12m after enrollment
Symptom-free Days in the Last 14 Days
Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
Measured: Repeated Measures at 12 months (with data also assessed at 3m and 6m)
Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use
Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d
Measured: Repeated measures at 6 and 12 months (3m data collected for repeated measures)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2016
- Study completionMay 2017
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen J. Teach, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor-investigator, Stephen J. Teach, MD, MPH, Children's National Research Institute
- Investigators
- Stephen Teach, MD, MPH, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374138
- Sponsor's protocol ID
- 5819
- Status last verified
- Aug 2019
- First submitted
- 10 Feb 2015
- Last updated
- 23 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Teach SJ, Shelef DQ, Foushee N, Horn IB, Yadav K, Wang Y, Rand CS, Streisand R. Randomized clinical trial of parental psychosocial stress management to improve asthma outcomes. J Asthma. 2021 Jan;58(1):121-132. doi: 10.1080/02770903.2019.1665063. Epub 2019 Sep 23.
PubMed 31545115
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Asthma Outcomes Through Stress Management
- ClinicalTrials.gov ID
- NCT02374138
- Acronym / sponsor ID
- 5819
- Conditions
- Asthma
- Keywords
- psychosocial stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Stephen J. Teach, MD, MPHUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- May 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Posted 23 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children.
A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes.
Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.
Detailed description
Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children.
A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes.
Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.
We will conduct a single blind, prospective randomized controlled trial comparing the IMPACT DC Asthma Clinic's existing intervention of guideline-based clinical care, education, and short-term care coordination (usual care) to usual care plus parental stress management in a cohort of up to 200 parent-child dyads of AA youth aged 4-12 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareIMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination |
| Intervention | Experimental | Behavioral: Parental stress managementParental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- self-identify as African-American
- both the legal guardian and primary asthma caregiver of an eligible child.
- parent-identified as African-American
- age 4-12 years inclusive at recruitment
- physician diagnosis of persistent asthma
Key exclusion criteria (5 listed)
- unable or unwilling to sign informed consent document
- exclusionary psychiatric condition, including but not limited to psychosis, based on the screening form at recruitment
- enrolled in another asthma research study.
- chronic medical condition (other than asthma) including but not limited to diabetes, sickle cell disease, heart disease, lung disease or neurological disorder.
- In addition, the PI may choose to not include a participant if he does not believe it is in the family's best interest to participate.
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 |
|---|---|---|
| Parental stress managementThe intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches." | Behavioural | Intervention |
| Usual CareIMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination | Other | Usual Care |
Primary outcome
Symptom-free Days in the Last 14 Days
Time frame: Repeated Measures at 6 months (3 month data collected to allow for repeated measures)
Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications
19 secondary outcomes
Asthma Morbidity - Nighttime Asthma Symptoms
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Asthma Severity and Control
Time frame: Repeated Measures at 3, 6, and 12 months
Asthma Medication Adherence
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Health Care Utilization - Emergency Department Visits for Asthma
Time frame: 12 months after enrollment
Asthma Exacerbations - Courses of Systemic Steroids
Time frame: Assessed at 6m and 12m following enrollment
Parental Stress
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Parental Depression
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Child Anxiety
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Child Depression
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Caregiver Quality of Life
Time frame: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Number of Participants With AEs and SAEs
Time frame: 12m follow up period
Economic Outcomes
Time frame: 12m follow-up period
Caregiver Smoking Behavior
Time frame: Repeated Measures at 6 and 12 months
Coping Strategies
Time frame: Repeated measures at 12m FU (6m data used for repeated measures)
Mindfulness
Time frame: Repeated Measures at 6 and 12 months
Parental Resilience
Time frame: Repeated Measures at 6 and 12 months
Exacerbations - Hospital Admissions
Time frame: Assessed at 6m and 12m after enrollment
Symptom-free Days in the Last 14 Days
Time frame: Repeated Measures at 12 months (with data also assessed at 3m and 6m)
Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use
Time frame: Repeated measures at 6 and 12 months (3m data collected for repeated measures)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31545115Teach SJ, Shelef DQ, Foushee N, Horn IB, Yadav K, Wang Y, Rand CS, Streisand R. Randomized clinical trial of parental psychosocial stress management to improve asthma outcomes. J Asthma. 2021 Jan;58(1):121-132. doi: 10.1080/02770903.2019.1665063. Epub 2019 Sep 23.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Stephen Teach, MD, MPH principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental stress management in people with Asthma, run by Stephen J. Teach, MD, MPH at 1 site 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 6 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 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2019). 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?
Symptom-free Days in the Last 14 Days (time frame: Repeated Measures at 6 months (3 month data collected to allow for repeated measures)). 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 NCT02374138, 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 23 Sep 2019.