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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a brief talk therapy called Enhanced IPT-B for Black mothers with depression symptoms whose children have asthma. It compares the therapy with usual care plus brief help coordinating care at a city asthma clinic for children. Researchers will see if it helps mothers feel less depressed, improves their children's asthma, and can be offered in the clinic.

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?

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Mother is the main caregiver of a child treated at the community asthma clinic.
  • Mother identifies as female and Black.
  • Mother is age 18 or older and speaks English.
  • Mother scores 8 or higher on the PHQ-9, a depression screening form, at the child's asthma clinic visit.
  • Child will be under age 18 for the full 6-month study.
  • Child has public health insurance.
  • Child has ongoing asthma diagnosed by a doctor.

Who can't join

  • Mother has a high risk of suicide based on screening at the child's asthma clinic visit.
  • Mother has bipolar disorder or mania, which can cause periods of very high mood or energy.
  • Mother has schizophrenia, a mental illness that can affect thoughts and sense of reality.
  • Mother currently has a problem with substance use or dependence.
  • Mother is currently facing serious physical violence from an intimate partner.
  • Study staff find that the mother cannot meaningfully take part in study activities.
  • Child has another major health condition, such as heart or lung disease, major delays in development, diabetes, seizures, or sickle cell disease.
  • Child is in another treatment study or program that includes a behavior-focused part or a new asthma treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

DC