BREATHE-Peds Pilot - I Focus Group Interviews

NCT05137223 | Completed

• 2 other identifiers: AAAT8015-I1R21NR019668-01A1
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Asthma; Asthma in Children

Keywords

Asthma; Adolescents; Dyads; Shared decision-making; Minority health

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 12 months

Study Arms (3)

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)

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Early adolescents (aged 10-14 years) with persistent uncontrolled asthma receiving care in federally-qualified health centers and their caregivers

You may qualify if:

• Aged 10-14 years
• Physician-diagnosed persistent asthma (defined as being prescribed a controller medication)

You may not qualify if:

• Serious mental health conditions
• Developmental delay
• Informal caregivers (e.g., parent, grandparent) of adolescents aged 10-14 years with physician-diagnosed persistent asthma
• Serious mental health conditions

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (3)

Urban Health Plan: Adolescent Health and Wellness

The Bronx, New York, 10459, United States

Location

Urban Health Plan: El Nuevo San Juan

The Bronx, New York, 10459, United States

Location

Urban Health Plan: Bella Vista

The Bronx, New York, 10474, United States

Location

Related Publications (16)

• Centers for Disease Control. Asthma Surveillance Data. Retrieved from https://www.cdc.gov/asthma/asthmadata.htm October 20, 2020.

  BACKGROUND

• 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.

  PMID: 29420459 BACKGROUND

• Akinbami 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.

  PMID: 19221156 BACKGROUND

• Claudio 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.

  PMID: 16242960 BACKGROUND

• Lara 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.

  PMID: 16396859 BACKGROUND

• Bruzzese 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.

  PMID: 15582346 BACKGROUND

• Dahl 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.

  PMID: 29469094 BACKGROUND

• Williams PG, Holmbeck GN, Greenley RN. Adolescent health psychology. J Consult Clin Psychol. 2002 Jun;70(3):828-42.

  PMID: 12090386 BACKGROUND

• Maggs 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

• 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.

  PMID: 25704083 BACKGROUND

• Rhee 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.

  PMID: 20970082 BACKGROUND

• Yang 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.

  PMID: 20880275 BACKGROUND

• Bruzzese 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.

  PMID: 22149141 BACKGROUND

• Holley 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.

  PMID: 27717193 BACKGROUND

• Bruzzese 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.

  PMID: 18411832 BACKGROUND

• George M, Bruzzese JM, Lynn S Sommers M, Pantalon MV, Jia H, Rhodes J, Norful AA, Chung A, Chittams J, Coleman D, Glanz K. Group-randomized trial of tailored brief shared decision-making to improve asthma control in urban black adults. J Adv Nurs. 2021 Mar;77(3):1501-1517. doi: 10.1111/jan.14646. Epub 2020 Nov 29.

  PMID: 33249632 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Maureen George, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Jean-Marie Bruzzese, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing, Columbia University Irving Medical Center

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 30, 2021
• Study Start: April 26, 2022
• Primary Completion: September 19, 2022
• Study Completion: September 19, 2022
• Last Updated: November 6, 2024

Record last verified: 2023-03

Locations

US (3)