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

This study is looking at ways to help mothers who have children with asthma and are experiencing symptoms of depression. It compares two approaches: Enhanced Brief Interpersonal Psychotherapy (IPT-B) and Supplemented Usual Care. Enhanced IPT-B involves eight weekly, 45-minute therapy sessions. Supplemented Usual Care means your child's doctor would discuss your depression screening results, offer information about depression, and provide a list of mental health resources. The main goal is to see if Enhanced IPT-B can reduce maternal depressive symptoms. Researchers also want to see if it improves your child's asthma management and health. This study is currently recruiting Black mothers, aged 18 or older, who are the primary caregiver of a child under 18 with asthma and have a PHQ-9 score of 8 or higher, indicating depressive symptoms.

Study design
This is a pilot study with 48 participants. It is a randomized controlled trial, meaning participants will be assigned by chance to either receive Enhanced Brief Interpersonal Psychotherapy or Supplemented Usual Care.
What's involved
If you join, you would either have eight weekly, 45-minute individual therapy sessions over 8-12 weeks, or receive information and resources from your child's doctor.
Compensation
Not stated in the trial record.
Follow-up
Your maternal depressive symptoms will be measured again 3 months after the study begins.

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NCT06623981

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

Recruiting
NAAll AgesInterventionalTreatment
Children's National Research Institute
~60 participants
Updated 2026-02-24 on ClinicalTrials.gov
What's tested:Enhanced Brief Interpersonal PsychotherapySupplemented Usual Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maternal depressive symptoms
Measured over T2 (3 months post-baseline)

Conditions

Asthma in Children
Depression

Explore related trials

AsthmaDepression

Where it's being run

1 sites across 1 states
District of Columbia1

Study leadership

  • Rachel Margolis, PhD, MSW · PRINCIPAL_INVESTIGATOR · Children's National Research Institute

Who to contact

Geraldine Mendez-Gonzalez
[email protected]
(202) 476-6956
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
\<18 years old for the duration of the 6-month study period
Publicly insured
Physician-diagnosed persistent asthma

Exclusion

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
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

What this trial measures

  • Maternal depressive symptomsT2 (3 months post-baseline)

    ≥ 50% reduction in depressive symptoms on the 9-item Patient Health Questionnaire (PHQ-9) at T2. The PHQ-9 score ranges from 0-27, with higher scores indicating more depressive symptoms. This variable will be dichotomized into 50% or greater reduction in depressive symptoms vs. less than 50% reduction in depressive symptoms from T1 to T2.