NCT05832437Completed
BREATHE-Peds Pilot- II III Trial and Post Trial
The Development and Pilot Testing of a Caregiver-Child Shared Decision-Making Intervention to Improve Asthma in Urban Youth
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 67 (actual)
- First submitted
- 10 Apr 2023
- Start date
- 4 May 2023
- Primary completion date
- 7 Nov 2024
- Lead sponsor
- Columbia University
- Diseases
- Asthma
- NCT number
- NCT05832437
What you commit to
- Study type: Interventional
- Participants enrolled: 67
- From 4 May 2023 to the primary completion date, 7 Nov 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Serious mental health conditions that preclude completion of study procedures or confound analyses or participation in a listening session
Other
- Non-English speaking
Who the study is looking for
- 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.
- Inclusion Criterion (clinicians):
- 1\. Those who manage a panel of pediatric asthma patients at partner FQHC.
Age in the registry: 10 years to 14 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Urban Health Plan: Adolescent Health and Wellness Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Urban Health Plan: Bella Vista Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Urban Health Plan: El Nuevo San Juan Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.