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The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic

RECRUITINGN/ASponsored by Children's National Research Institute
Actively Recruiting
PhaseN/A
SponsorChildren's National Research Institute
Started2024-10-15
Est. completion2026-12-15
Eligibility
Healthy vol.Accepted
Locations1 site

Summary

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?

Eligibility

Healthy volunteers accepted
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

Conditions3

AsthmaAsthma in ChildrenDepression

Locations1 site

Children's National Hospital
Washington D.C., District of Columbia, 20010
Geraldine Mendez-Gonzalez202-476-6956GMENDEZGON@childrensnational.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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