Breathe With Ease: A Unique Approach to Managing Stress (BEAMS)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
District of Columbia
-
Washington, District of Columbia, Vereinigte Staaten, 20010
- Children's National Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
We plan to enroll parent-child dyads that meet the following criteria:
Inclusion criteria (Parent):
- self-identify as African-American
- both the legal guardian and primary asthma caregiver of an eligible child.
Exclusion criteria (Parent):
- 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.
Inclusion criteria (Child):
- parent-identified as African-American
- age 4-12 years inclusive at recruitment
- physician diagnosis of persistent asthma
- publicly financed insurance
Exclusion criteria (Child):
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Usual Care
IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
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IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
|
|
Experimental: Intervention
Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.
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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."
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Symptom-free Days in the Last 14 Days
Zeitfenster: 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
|
Repeated Measures at 6 months (3 month data collected to allow for repeated measures)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Asthma Morbidity - Nighttime Asthma Symptoms
Zeitfenster: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
Nights of asthma symptoms in prior 14d
|
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
|
Asthma Severity and Control
Zeitfenster: Repeated Measures at 3, 6, and 12 months
|
Repeated Measures at 3, 6, and 12 months
|
|
|
Asthma Medication Adherence
Zeitfenster: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
Reported use of inhaled corticosteroids and LTRA in past two days
|
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
|
Health Care Utilization - Emergency Department Visits for Asthma
Zeitfenster: 12 months after enrollment
|
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
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12 months after enrollment
|
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Asthma Exacerbations - Courses of Systemic Steroids
Zeitfenster: Assessed at 6m and 12m following enrollment
|
Courses of systemic steroids over 12m follow up period
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Assessed at 6m and 12m following enrollment
|
|
Parental Stress
Zeitfenster: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
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.
|
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
|
Parental Depression
Zeitfenster: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
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.
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Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
|
Child Anxiety
Zeitfenster: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
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.
|
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
|
Child Depression
Zeitfenster: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
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.
|
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
|
Caregiver Quality of Life
Zeitfenster: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
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.
|
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
|
Number of Participants With AEs and SAEs
Zeitfenster: 12m follow up period
|
Safety data: Number of Participants with AEs and SAEs
|
12m follow up period
|
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Economic Outcomes
Zeitfenster: 12m follow-up period
|
Analysis of costs of care in both groups
|
12m follow-up period
|
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Caregiver Smoking Behavior
Zeitfenster: Repeated Measures at 6 and 12 months
|
parent report of cigarettes smoked per day
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Repeated Measures at 6 and 12 months
|
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Coping Strategies
Zeitfenster: Repeated measures at 12m FU (6m data used for repeated measures)
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Brief COPE
|
Repeated measures at 12m FU (6m data used for repeated measures)
|
|
Mindfulness
Zeitfenster: Repeated Measures at 6 and 12 months
|
Interpersonal Mindfulness in Parenting
|
Repeated Measures at 6 and 12 months
|
|
Parental Resilience
Zeitfenster: Repeated Measures at 6 and 12 months
|
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.
|
Repeated Measures at 6 and 12 months
|
|
Exacerbations - Hospital Admissions
Zeitfenster: Assessed at 6m and 12m after enrollment
|
Number of participants with hospital admissions due to exacerbations
|
Assessed at 6m and 12m after enrollment
|
|
Symptom-free Days in the Last 14 Days
Zeitfenster: Repeated Measures at 12 months (with data also assessed at 3m and 6m)
|
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
|
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
Zeitfenster: Repeated measures at 6 and 12 months (3m data collected for repeated measures)
|
Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d
|
Repeated measures at 6 and 12 months (3m data collected for repeated measures)
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Sociodemographics
Zeitfenster: Baseline
|
Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history
|
Baseline
|
|
Number of Participants With Positive Smoke Exposure
Zeitfenster: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
Participants with environmental smoke exposure.
Responses were regrouped as negative (none) or positive (daily, often, or rarely) based on two questions: "How often did anyone smoke inside the home where child usually lives?" or "How often did anyone smoke in the room where child usually sleeps?"
A positive response on either or both questions was considered positive exposure.
|
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
|
|
Parental Health Literacy
Zeitfenster: Baseline
|
Single Item Literacy Screener (SILS)
|
Baseline
|
|
Use of Existing Ancillary Services
Zeitfenster: Assessed at 6m and 12m following enrollment
|
Assessed at 6m and 12m following enrollment
|
|
|
Parental Resilience
Zeitfenster: Baseline
|
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.
|
Baseline
|
|
Intervention Component Uptake
Zeitfenster: 6 month intervention period
|
Completion of intervention sessions
|
6 month intervention period
|
|
Intervention Satisfaction
Zeitfenster: 6 month intervention period
|
Brief survey of satisfaction with intervention components.
|
6 month intervention period
|
|
Intervention Fidelity
Zeitfenster: 6 month intervention period
|
Checklist of staff's fidelity to individual components of intervention protocol
|
6 month intervention period
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Stephen Teach, MD, MPH, Children's National Health System
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 5819
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