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NCT06623981Recruiting

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

Testing the Effectiveness and Implementation of an Evidence-Based Maternal Depression Treatment in an Urban Pediatric Asthma Clinic

Source: ClinicalTrials.gov · Last updated 24 Feb 2026

Brief summary (registry, in English)

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?

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
4 Sept 2024
Start date
15 Oct 2024
Primary completion date
15 Dec 2026
Lead sponsor
Children's National Research Institute
Diseases
Asthma
NCT number
NCT06623981

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 15 Oct 2024 to the primary completion date, 15 Dec 2026
  • 1 site 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

  • Bipolar disorder or mania
  • Significant medical co-morbidity (e.g., disorders of the cardiorespiratory system, significant developmental delay, diabetes, seizure disorder, and sickle cell disease)

Other

  • Maternal:
  • Acutely suicidal (high risk on the C-SSRS at child's asthma clinic visit)
  • 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:
  • Enrolled in another intervention with a behavioral component and/or novel asthma therapeutics

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's National Hospital
Coordinator of this site? Confirm its status		Washington D.C.United StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.