Actively Recruiting

Phase Not Applicable
All Genders
NCT06623981

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

Led by Children's National Research Institute · Updated on 2026-02-24

60

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

Sponsors

C

Children's National Research Institute

Lead Sponsor

N

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborating Sponsor

AI-Summary

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?

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be a female (self-identified) primary caregiver of a child with asthma seen at the community-based asthma clinic
  • Self-identify as Black
  • Be 18 years of age or older
  • Speak English
  • Have a PHQ-9 score of 8 or higher during depression screening at the child's clinic visit
  • Have a child under 18 years old during the 6-month study period
  • Child must be publicly insured
  • Child must have physician-diagnosed persistent asthma
Not Eligible

You will not qualify if you...

  • Maternal acute suicidality (high risk on the C-SSRS at child's clinic visit)
  • Maternal bipolar disorder or mania
  • Maternal schizophrenia
  • Current maternal substance abuse or dependence
  • Current serious physical intimate partner violence
  • Lack of capacity to participate meaningfully in study procedures as assessed during screening
  • Child has significant medical co-morbidity such as cardiorespiratory disorders, developmental delay, diabetes, seizure disorder, or sickle cell disease
  • Child is enrolled in another intervention with a behavioral component or novel asthma therapeutics

AI-Screening

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Trial Site Locations

Total: 1 location

1

Children's National Hospital

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

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Research Team

G

Geraldine Mendez-Gonzalez

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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