The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic
Recruiting · NCT06623981 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's National Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to test the effectiveness and implementation of delivering Enhanced Brief Interpersonal Psychotherapy (IPT-B), an evidence-based maternal depression treatment, to mothers of children under the age of 18 in an urban pediatric asthma clinic. Researchers will compare Enhanced IPT-B and supplemented usual care (brief care coordination). The main questions the trial aims to answer are: 1. Does Enhanced IPT-B decrease maternal depressive symptoms? 2. Does Enhanced IPT-B improve child asthma management and health outcomes (exacerbations, symptoms, control)? 3. What are the preliminary implementation outcomes of delivering Enhanced IPT-B in an urban pediatric asthma clinic?
Who can take part
Inclusion criteria
- Maternal:
- Primary caregiver of the child with asthma seen at the community-based asthma clinic
- Female (self-identified)
- Black (self-identified)
- ≥ 18 years of age
- English-speaking
- PHQ-9 ≥ 8 during standardized screening at the child with asthma's clinic visit
- Child:
- \<18 years old for the duration of the 6-month study period
- Publicly insured
- Physician-diagnosed persistent asthma
Exclusion criteria
- Maternal:
- Acutely suicidal (high risk on the C-SSRS at child's asthma clinic visit)
- Bipolar disorder or mania
- Schizophrenia
- Current substance abuse/dependence
- Current serious physical intimate partner violence (IPV)
- Lack of capacity to meaningfully participate in study procedures, as assessed by study staff during screening
- Child:
- Significant medical co-morbidity (e.g., disorders of the cardiorespiratory system, significant developmental delay, diabetes, seizure disorder, and sickle cell disease)
- Enrolled in another intervention with a behavioral component and/or novel asthma therapeutics
Where it is running
1 location listed across 1 US state.
- Children's National Hospital - Washington D.C., District of Columbia, United States