N/A
Completed N=67
BREATHE-Peds Pilot- II III Trial and Post Trial
Source: ClinicalTrials.gov NCT05832437 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Mean Asthma Control Questionnaire Score — 2.7; 2.63; 0.98; 0.82 score on a scale
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 II and III only
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Asthma Control Questionnaire Score |
2.7; 2.63; 0.98; 0.82; 0.80; 0.58 | — |
| SECONDARY Mean Shared Decision Making-Questionnaire-9 Score |
42.9; 39.55 | — |
| SECONDARY Mean Medication Adherence Report Scale - Asthma Score |
4.13; 3.87; 4.13; 4.05; 4.34; 4.26 | — |
| SECONDARY Mean Asthma Quality of Life Questionnaire Score |
5.37; 5.72; 5.78; 6.44; 5.89; 6.17 | — |
| SECONDARY Mean Asthma Impairment and Risk Questionnaire Score |
2.79; 3.00; 1.46; 1.64; 1.08; 1.45 | — |
Eligibility Criteria
Inclusion Criteria (Dyad participants):
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):
- Those who manage a panel of pediatric asthma patients at partner FQHC.
Exclusion Criteria (Dyad participants):
- Non-English speaking
- Serious mental health conditions that preclude completion of study procedures or confound analyses or participation in a listening session
Data sourced from ClinicalTrials.gov (NCT05832437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.