Asthma in ChildrenNCT05832437
BREATHE-Peds Pilot- II III Trial and Post Trial
A study testing BREATHE-Peds Intervention in people with 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 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- What is being tested?
- BREATHE-Peds Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 May 2023to 13 Dec 2024
- Phase
- Interventional
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 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Dyad (caregiver/child) participants will
- Early adolescents (10-14 years of age) or the caregiver of early adolescents (10-14 years of age)
- Have or the caregiver of a child that has clinician-diagnosed persistent asthma (defined as being prescribed inhaled corticosteroids in the last 12 months)
- Receive asthma care at a partner FQHC and
- Child screens positive for uncontrolled asthma as measured by the Asthma Control Questionnaire- 6 items (ACQ-6) and child or caregiver has erroneous beliefs as measured by the Conventional and Alternative Management for Asthma (CAM-A) survey.
- 1. Those who manage a panel of pediatric asthma patients at partner FQHC.
Who cannot join
- Non-English speaking
- Serious mental health conditions that preclude completion of study procedures or confound analyses or participation in a listening session
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 II and III 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 II and Phase III) ) a pilot validation phase will conduct a group-randomized trial in two FQHCs with 85 dyads treated by 8 PCPs (10 dyads/PCP) randomized to 1 of 2 study arms: (a) BREATHE-PEDS-Peds (n=42 dyads), or (b) dose-matched attention control (n=43 dyads). Post-trial interviews with PCPs, caregivers, and their children to evaluate satisfaction with the intervention will be conducted; caregiver-child dyads will be followed for 3 months post-intervention to assess the impact of BREATHE-PEDS-Peds on asthma outcomes.
- Conditions
- Asthma in Children
- Being tested
- BREATHE-Peds Intervention, Control Intervention
- 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.
BREATHE-Peds InterventionBehavioural
BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).
Control InterventionBehavioural
The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).
| Study group | Role | What they receive |
|---|---|---|
| BREATHE-Peds intervention | Experimental | The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. Receives: Behavioral: BREATHE-Peds Intervention |
| Control Intervention | Active comparator | The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control. Receives: Behavioral: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Asthma Control Questionnaire Score
Asthma control as measured by improvements in Asthma Control Questionnaire (ACQ) score, a 6-item validated and widely used measure of asthma control. Each question is rated from 0 to 6. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. The overall ACQ score is the mean score of all 6 items with scores ranging from 0 to 6. Lower mean scores indicate greater asthma control (better outcome), higher mean scores indicate lesser asthma control.
Measured: Up to 3 months post intervention
Secondary outcomes (4)
Mean Shared Decision Making-Questionnaire-9 Score
The Shared Decision Making (SDM) Questionnaire-9, is a patient reported, 9-item validated instrument that consists of nine statements that measure the decisional process in medical visits from both patients' and physicians' perspectives. Each statement is rated on a six-point scale from "completely disagree" (0) to "completely agree" (5). The raw total score of all items range from 0-45. Lower scores indicate lower levels of shared decision making between provider and patient (in this study as it pertains to asthma treatment) and higher scores indicate higher levels of shared decision making (better outcome).
Measured: Baseline (immediately post-intervention)
Mean Medication Adherence Report Scale - Asthma Score
Inhaled corticosteroid adherence as measured by the Medication Adherence Report Scale - Asthma (MARS-A). Participants are asked to rate the frequency with which they engage in each of the adherence-related behaviors on a five-point scale, where 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. Scores for each item are summed to give a total score ranging from 1 to 5, with higher scores indicating higher levels of reported adherence.
Measured: Up to 3 months post intervention
Mean Asthma Quality of Life Questionnaire Score
Asthma quality of life improvements as measured by the Asthma Quality of Life Questionnaire (AQLQ), a 32-item validated and widely-used measure consisting of 4 domains: symptoms (11 items), emotions (5 items), environment (4 items), and activities (12 items). Each item is measured on a 7-point Likert scale (7 = not impaired at all, 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains. The overall score ranges from 1 to 7, where lower mean scores indicate lower quality of life due to asthma (worse outcome).
Measured: Up to 3 months post intervention
Mean Asthma Impairment and Risk Questionnaire Score
Asthma Impairment and Risk Questionnaire (AIRQ) is a 10-item valid and reliable survey that measures bot domains of control: symptom impairments and risk for uncontrolled asthma. AIRQ™ score ranges from 0-10, measured by total number of YES answers. Score tally of 0-1 indicates well controlled asthma, scores 2-4 indicate not well controlled asthma, and scores 5-10 indicate very poorly controlled asthma.
Measured: Up to 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start4 May 2023
- Primary completion7 Nov 2024
- Study completion13 Dec 2024
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 (16)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 67 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
- NCT05832437
- Sponsor's protocol ID
- AAAT8015-Trial & Post-Trial
- Other IDs
- 1R21NR019668-01A1
- Status last verified
- Oct 2025
- First submitted
- 10 Apr 2023
- Last updated
- 17 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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