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

NCT06623981

RecruitingNA

Sponsor: Children's National Research Institute

Conditions: Asthma in Children, Depression

Interventions: Enhanced Brief Interpersonal Psychotherapy, Supplemented Usual Care

Countries: United States

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 overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (1)
  • Washington D.C., District of Columbia, United States