AsthmaNCT05137223
BREATHE-Peds Pilot - I Focus Group Interviews
An observational study of Asthma and Asthma in Children, run by Columbia University at 3 sites in United States.
Trial summary
The overall aims of this study are to develop and pilot test BRief intervention to Evaluate Asthma THErapy (BREATHE)-Peds, a dyadic shared decision-making intervention, to improve asthma by supporting self-management among racial and ethnic minority early adolescents receiving care for uncontrolled asthma in… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, Asthma in Children
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Apr 2022to 19 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Early adolescents (aged 10-14 years) with persistent uncontrolled asthma receiving care in federally-qualified health centers and their caregivers
Who may be able to join
- Aged 10-14 years
- Physician-diagnosed persistent asthma (defined as being prescribed a controller medication)
- Informal caregivers (e.g., parent, grandparent) of adolescents aged 10-14 years with physician-diagnosed persistent asthma
Who cannot join
- Serious mental health conditions
- Developmental delay
- Serious mental health conditions
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Urban Health Plan: Adolescent Health and Wellness
The Bronx, New York, 10459
Urban Health Plan: El Nuevo San Juan
The Bronx, New York, 10459
Urban Health Plan: Bella Vista
The Bronx, New York, 10474
About this study
Official title: The Development and Pilot Testing of a Caregiver-Child Shared Decision-Making Intervention to Improve Asthma in Urban Youth
The overall aims of this study are to develop and pilot test BRief intervention to Evaluate Asthma THErapy (BREATHE)-Peds, a dyadic shared decision-making intervention, to improve asthma by supporting self-management among racial and ethnic minority early adolescents receiving care for uncontrolled asthma in federally-qualified health centers (FQHCs) in urban communities. Aim 1 (Phase I) involves developing the intervention through focus groups with early adolescents and caregivers. Aims 2 and 3 (Phase II) involve preliminary testing of the intervention through a pilot randomized controlled trial. This record is for Phase I only.
Read the detailed description
Despite high asthma prevalence and morbidity among adolescents (highest among Black and Hispanic youth and early adolescents aged 10-14), there is a lack of developmentally appropriate interventions for this at-risk group. Racial and ethnic minority early adolescents have sub-optimal asthma self-management. Critical health behaviors that emerge during early adolescence affect lifelong patterns; therefore, early adolescence offers a unique opportunity to intervene. Additionally, successful self-management requires the right division of responsibility between adolescents and their caregivers. Thus, intervening simultaneously with early adolescents and their caregivers who can help support the adolescent's growing autonomy to self-manage their condition has the potential for a synergistic effect.
Prior studies have demonstrated the effects of improved asthma control of BREATHE, a brief one-time shared decision-making intervention for Black adults with uncontrolled asthma that utilizes motivational interviewing delivered by primary care providers. This study (i.e., Phase I) attempts to build on these promising results by adapting BREATHE to caregiver-early adolescent dyads. Phase I of the study will involve conducting up to 6 focus groups to identify components of BREATHE that are relevant to racial and ethnic minority early adolescents with uncontrolled asthma receiving care at FQHCs in urban communities and their caregivers. Focus groups will be composed of ~10 participants each: (a) two groups of early adolescents aged 10-14 with asthma; (b) two groups of the caregivers of the youth in Group A; and (c) two groups of adolescent-caregiver dyads who did not participate in Group A or B. Investigators will use the focus group results to write BREATHE-Peds, making modifications based on feedback from two primary care providers and two pediatric pulmonologists.
- Conditions
- Asthma, Asthma in Children
- Keywords
- Asthma, Adolescents, Dyads, Shared decision-making, Minority health
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Only Focus Groups | 20 early adolescents (ages 10-14) with physician-diagnosed persistent asthma (i.e., prescribed a controller medication) receiving care at a FQHC | |
| Caregiver Only Focus Groups | 20 informal caregivers (e.g., parent, grandparent) of early adolescents with physician-diagnosed persistent asthma receiving care at a FQHC | |
| Adolescent and Caregiver Focus Groups | 10 adolescents with physician-diagnosed persistent asthma receiving care at a FQHC and their caregivers (both of whom did not participate in either previous group for a total of 20 participants in the group cohort) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who successfully complete the focus group
Focus groups will be held with early adolescents and caregivers to identify relevant components of a pre-existing intervention (i.e., BREATHE) for a new intervention (i.e., BREATHE-Peds). Information collected during these focus groups will aid in the design/implementation of the intervention to be pilot-tested in Phase II.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start26 Apr 2022
- Primary completion19 Sep 2022
- Study completion19 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Maureen George, Columbia University
- Investigators
- Maureen George, PhD, Principal investigator, Columbia UniversityJean-Marie Bruzzese, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137223
- Sponsor's protocol ID
- AAAT8015-I
- Other IDs
- 1R21NR019668-01A1
- Status last verified
- Mar 2023
- First submitted
- 16 Nov 2021
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Centers for Disease Control. Asthma Surveillance Data. Retrieved from https://www.cdc.gov/asthma/asthmadata.htm October 20, 2020.
Zahran HS, Bailey CM, Damon SA, Garbe PL, Breysse PN. Vital Signs: Asthma in Children - United States, 2001-2016. MMWR Morb Mortal Wkly Rep. 2018 Feb 9;67(5):149-155. doi: 10.15585/mmwr.mm6705e1.
PubMed 29420459Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status of childhood asthma in the United States, 1980-2007. Pediatrics. 2009 Mar;123 Suppl 3:S131-45. doi: 10.1542/peds.2008-2233C.
PubMed 19221156Claudio L, Stingone JA, Godbold J. Prevalence of childhood asthma in urban communities: the impact of ethnicity and income. Ann Epidemiol. 2006 May;16(5):332-40. doi: 10.1016/j.annepidem.2005.06.046. Epub 2005 Oct 20.
PubMed 16242960Lara M, Akinbami L, Flores G, Morgenstern H. Heterogeneity of childhood asthma among Hispanic children: Puerto Rican children bear a disproportionate burden. Pediatrics. 2006 Jan;117(1):43-53. doi: 10.1542/peds.2004-1714.
PubMed 16396859Bruzzese JM, Bonner S, Vincent EJ, Sheares BJ, Mellins RB, Levison MJ, Wiesemann S, Du Y, Zimmerman BJ, Evans D. Asthma education: the adolescent experience. Patient Educ Couns. 2004 Dec;55(3):396-406. doi: 10.1016/j.pec.2003.04.009.
PubMed 15582346Dahl RE, Allen NB, Wilbrecht L, Suleiman AB. Importance of investing in adolescence from a developmental science perspective. Nature. 2018 Feb 21;554(7693):441-450. doi: 10.1038/nature25770.
PubMed 29469094Williams PG, Holmbeck GN, Greenley RN. Adolescent health psychology. J Consult Clin Psychol. 2002 Jun;70(3):828-42.
PubMed 12090386Maggs JL, Schulenberg J, Hurrelmann K. Developmental transitions during adolescence: health promotion implications. In: Schulenberg J, Maggs JL, Hurrelman K, eds. Health Risks and Developmental Transitions During Adolescence. New York: Cambridge University Press. 1997;522-546.
Klok T, Kaptein AA, Brand PLP. Non-adherence in children with asthma reviewed: The need for improvement of asthma care and medical education. Pediatr Allergy Immunol. 2015 May;26(3):197-205. doi: 10.1111/pai.12362.
PubMed 25704083Rhee H, Belyea MJ, Brasch J. Family support and asthma outcomes in adolescents: barriers to adherence as a mediator. J Adolesc Health. 2010 Nov;47(5):472-8. doi: 10.1016/j.jadohealth.2010.03.009. Epub 2010 May 14.
PubMed 20970082Yang TO, Sylva K, Lunt I. Parent support, peer support, and peer acceptance in healthy lifestyle for asthma management among early adolescents. J Spec Pediatr Nurs. 2010 Oct;15(4):272-81. doi: 10.1111/j.1744-6155.2010.00247.x.
PubMed 20880275Bruzzese JM, Stepney C, Fiorino EK, Bornstein L, Wang J, Petkova E, Evans D. Asthma self-management is sub-optimal in urban Hispanic and African American/black early adolescents with uncontrolled persistent asthma. J Asthma. 2012 Feb;49(1):90-7. doi: 10.3109/02770903.2011.637595. Epub 2011 Dec 7.
PubMed 22149141Holley S, Morris R, Knibb R, Latter S, Liossi C, Mitchell F, Roberts G. Barriers and facilitators to asthma self-management in adolescents: A systematic review of qualitative and quantitative studies. Pediatr Pulmonol. 2017 Apr;52(4):430-442. doi: 10.1002/ppul.23556. Epub 2016 Oct 7.
PubMed 27717193Bruzzese JM, Unikel L, Gallagher R, Evans D, Colland V. Feasibility and impact of a school-based intervention for families of urban adolescents with asthma: results from a randomized pilot trial. Fam Process. 2008 Mar;47(1):95-113. doi: 10.1111/j.1545-5300.2008.00241.x.
PubMed 18411832
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Pilot Testing of a Caregiver-Child Shared Decision-Making Intervention to Improve Asthma in Urban Youth
- ClinicalTrials.gov ID
- NCT05137223
- Acronym / sponsor ID
- AAAT8015-I
- Conditions
- Asthma, Asthma in Children
- Keywords
- Asthma, Adolescents, Dyads, Shared decision-making, Minority health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aims of this study are to develop and pilot test BRief intervention to Evaluate Asthma THErapy (BREATHE)-Peds, a dyadic shared decision-making intervention, to improve asthma by supporting self-management among racial and ethnic minority early adolescents receiving care for uncontrolled asthma in federally-qualified health centers (FQHCs) in urban communities. Aim 1 (Phase I) involves developing the intervention through focus groups with early adolescents and caregivers. Aims 2 and 3 (Phase II) involve preliminary testing of the intervention through a pilot randomized controlled trial. This record is for Phase I only.
Detailed description
Despite high asthma prevalence and morbidity among adolescents (highest among Black and Hispanic youth and early adolescents aged 10-14), there is a lack of developmentally appropriate interventions for this at-risk group. Racial and ethnic minority early adolescents have sub-optimal asthma self-management. Critical health behaviors that emerge during early adolescence affect lifelong patterns; therefore, early adolescence offers a unique opportunity to intervene. Additionally, successful self-management requires the right division of responsibility between adolescents and their caregivers. Thus, intervening simultaneously with early adolescents and their caregivers who can help support the adolescent's growing autonomy to self-manage their condition has the potential for a synergistic effect.
Prior studies have demonstrated the effects of improved asthma control of BREATHE, a brief one-time shared decision-making intervention for Black adults with uncontrolled asthma that utilizes motivational interviewing delivered by primary care providers. This study (i.e., Phase I) attempts to build on these promising results by adapting BREATHE to caregiver-early adolescent dyads. Phase I of the study will involve conducting up to 6 focus groups to identify components of BREATHE that are relevant to racial and ethnic minority early adolescents with uncontrolled asthma receiving care at FQHCs in urban communities and their caregivers. Focus groups will be composed of ~10 participants each: (a) two groups of early adolescents aged 10-14 with asthma; (b) two groups of the caregivers of the youth in Group A; and (c) two groups of adolescent-caregiver dyads who did not participate in Group A or B. Investigators will use the focus group results to write BREATHE-Peds, making modifications based on feedback from two primary care providers and two pediatric pulmonologists.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adolescent Only Focus Groups | – | –20 early adolescents (ages 10-14) with physician-diagnosed persistent asthma (i.e., prescribed a controller medication) receiving care at a FQHC |
| Caregiver Only Focus Groups | – | –20 informal caregivers (e.g., parent, grandparent) of early adolescents with physician-diagnosed persistent asthma receiving care at a FQHC |
| Adolescent and Caregiver Focus Groups | – | –10 adolescents with physician-diagnosed persistent asthma receiving care at a FQHC and their caregivers (both of whom did not participate in either previous group for a total of 20 participants in the group cohort) |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Early adolescents (aged 10-14 years) with persistent uncontrolled asthma receiving care in federally-qualified health centers and their caregivers
Key inclusion criteria (3 listed)
- Aged 10-14 years
- Physician-diagnosed persistent asthma (defined as being prescribed a controller medication)
- Informal caregivers (e.g., parent, grandparent) of adolescents aged 10-14 years with physician-diagnosed persistent asthma
Key exclusion criteria (3 listed)
- Serious mental health conditions
- Developmental delay
- Serious mental health conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants who successfully complete the focus group
Time frame: up to 12 months
Focus groups will be held with early adolescents and caregivers to identify relevant components of a pre-existing intervention (i.e., BREATHE) for a new intervention (i.e., BREATHE-Peds). Information collected during these focus groups will aid in the design/implementation of the intervention to be pilot-tested in Phase II.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- BackgroundCenters for Disease Control. Asthma Surveillance Data. Retrieved from https://www.cdc.gov/asthma/asthmadata.htm October 20, 2020.
- Background: PubMed 29420459Zahran HS, Bailey CM, Damon SA, Garbe PL, Breysse PN. Vital Signs: Asthma in Children - United States, 2001-2016. MMWR Morb Mortal Wkly Rep. 2018 Feb 9;67(5):149-155. doi: 10.15585/mmwr.mm6705e1.
- Background: PubMed 19221156Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status of childhood asthma in the United States, 1980-2007. Pediatrics. 2009 Mar;123 Suppl 3:S131-45. doi: 10.1542/peds.2008-2233C.
- Background: PubMed 16242960Claudio L, Stingone JA, Godbold J. Prevalence of childhood asthma in urban communities: the impact of ethnicity and income. Ann Epidemiol. 2006 May;16(5):332-40. doi: 10.1016/j.annepidem.2005.06.046. Epub 2005 Oct 20.
- Background: PubMed 16396859Lara M, Akinbami L, Flores G, Morgenstern H. Heterogeneity of childhood asthma among Hispanic children: Puerto Rican children bear a disproportionate burden. Pediatrics. 2006 Jan;117(1):43-53. doi: 10.1542/peds.2004-1714.
- Background: PubMed 15582346Bruzzese JM, Bonner S, Vincent EJ, Sheares BJ, Mellins RB, Levison MJ, Wiesemann S, Du Y, Zimmerman BJ, Evans D. Asthma education: the adolescent experience. Patient Educ Couns. 2004 Dec;55(3):396-406. doi: 10.1016/j.pec.2003.04.009.
- Background: PubMed 29469094Dahl RE, Allen NB, Wilbrecht L, Suleiman AB. Importance of investing in adolescence from a developmental science perspective. Nature. 2018 Feb 21;554(7693):441-450. doi: 10.1038/nature25770.
- Background: PubMed 12090386Williams PG, Holmbeck GN, Greenley RN. Adolescent health psychology. J Consult Clin Psychol. 2002 Jun;70(3):828-42.
- BackgroundMaggs JL, Schulenberg J, Hurrelmann K. Developmental transitions during adolescence: health promotion implications. In: Schulenberg J, Maggs JL, Hurrelman K, eds. Health Risks and Developmental Transitions During Adolescence. New York: Cambridge University Press. 1997;522-546.
- Background: PubMed 25704083Klok T, Kaptein AA, Brand PLP. Non-adherence in children with asthma reviewed: The need for improvement of asthma care and medical education. Pediatr Allergy Immunol. 2015 May;26(3):197-205. doi: 10.1111/pai.12362.
- Background: PubMed 20970082Rhee H, Belyea MJ, Brasch J. Family support and asthma outcomes in adolescents: barriers to adherence as a mediator. J Adolesc Health. 2010 Nov;47(5):472-8. doi: 10.1016/j.jadohealth.2010.03.009. Epub 2010 May 14.
- Background: PubMed 20880275Yang TO, Sylva K, Lunt I. Parent support, peer support, and peer acceptance in healthy lifestyle for asthma management among early adolescents. J Spec Pediatr Nurs. 2010 Oct;15(4):272-81. doi: 10.1111/j.1744-6155.2010.00247.x.
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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.
Maureen George, PhD principal investigator
Columbia University
Jean-Marie Bruzzese, PhD principal investigator
Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Asthma in Children, run by Columbia University at 3 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 3 inclusion and 3 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 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants who successfully complete the focus group (time frame: up to 12 months). 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 NCT05137223, which also lists 16 linked publications.
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 6 Nov 2024.