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

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?

Study Overview

• Status: Recruiting
• Conditions: Depression; Asthma in Children
• Intervention / Treatment: Behavioral: Enhanced Brief Interpersonal Psychotherapy; Behavioral: Supplemented Usual Care

Detailed Description

The purpose of the study is to determine the effectiveness and implementation of Brief Enhanced Interpersonal Psychotherapy (IPT-B), an evidence-based treatment for maternal depression, delivered in an urban pediatric asthma clinic. This study is a pilot Hybrid Type 1 Effectiveness-Implementation, single-blinded, prospective randomized controlled trial. A parallel two-group design will be used to evaluate the impact of the intervention (Enhanced IPT-B) among a sample of 48 Black mothers of children under the age of 18 with asthma. Mothers with PHQ-9 ≥ 8 will be identified in the asthma clinic through routine depression screening during the child's visit and recruited to participate in the study if they meet eligibility criteria. Following the informed consent process, mothers randomized to the intervention group will receive Enhanced IPT-B. Enhanced IPT-B consists of a single, 45-60-minute pre-treatment engagement session followed by eight weekly, 45-minute individual psychotherapy sessions carried out by a licensed mental health clinician within an 8-12-week timeframe. Mothers randomized to the comparison group will receive Supplemented Usual Care which involves short-term care coordination to access community mental health resources. Data on maternal mental health, child asthma management and outcomes, and child mental health will be collected from mothers and children at baseline, 3 months post-baseline, and 6 months post-baseline. Data on implementation outcomes will be collected from mothers and asthma clinic leadership and staff. Quantitative and qualitative data analysis strategies will be utilized to answer the research questions.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geraldine Mendez-Gonzalez; Phone Number: (202) 476-6956; Email: GMENDEZGON@childrensnational.org

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • Children's National Hospital
      • Principal Investigator: Rachel Margolis, PhD, MSW
      • Contact: Geraldine Mendez-Gonzalez; Phone Number: 202-476-6956; Email: GMENDEZGON@childrensnational.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced IPT-B; Enhanced Brief Interpersonal Psychotherapy	Behavioral: Enhanced Brief Interpersonal Psychotherapy; Enhanced IPT-B consists of a single, 45-60-minute pre-treatment engagement session followed by eight weekly, 45-minute individual sessions carried out within an 8-12-week timeframe.
Active Comparator: Supplemented Usual Care; Short-term care coordination	Behavioral: Supplemented Usual Care; Usual care for caregivers with depressive symptoms involves the asthma clinic physician discussing the PHQ-9 results with the caregiver, providing brief psychoeducation on depression and giving the caregiver a written list of mental health resources. Usual care will be supplemented by providing short-term care coordination. Care coordination will involve assisting the participant in calling a mental health clinic to make an appointment and one follow-up phone call within two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal depressive symptoms	≥ 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.	T2 (3 months post-baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically significant maternal depressive symptoms	9-item Patient Health Questionnaire (PHQ-9) score less than 10 (i.e., not clinically significant) at T2. The PHQ-9 score ranges from 0-27, with higher scores indicating more depressive symptoms. A score of 10 or more indicates clinically significant symptoms. This variable will be dichotomized into clinically significant and not clinically significant.	T2 (3 months post-baseline)
Child asthma exacerbations	Number of asthma exacerbations requiring steroids in the past 6 months	T3 (6 months post-baseline)
Child asthma symptoms	Mother-reported number of child asthma symptom-free days during the prior 14 days	T2 (3 months post-baseline), T3 (6 months post-baseline)
Maintenance	Percentage of enrolled mothers who remain in the study	T3 (6 months post-baseline)
Acceptability	Mean treatment satisfaction survey score on the Client Satisfaction Questionnaire	T2 (3 months post-baseline)
Maternal anxiety symptoms	Scores on the 7-item Generalized Anxiety Disorder sale (GAD-7). Scores range from 0-21, with higher scores indicating more anxiety.	T2 (3-months post-baseline) and T3 (6months post-baseline)
Maternal PTSD symptoms	Score on the PTSD Checklist for DSM-5 (PCL-5), a validated self-report measure of PTSD symptoms in adults. Scores on the PCL-5 range from 0-80, with higher scores indicating more PTSD symptoms.	T2 (3 months post-baseline) and T3 (6 months post-baseline)
Child depressive symptoms	Mother report of child depressive symptoms on the PROMIS Parent Proxy Depressive Symptoms v3.0- Short Form 6a. Raw scores on the measure range from 6-30, with higher scores indicating more depressive symptoms.	T2 (3 months post-baseline) and T3 (6 months post-baseline)
Child anxiety symptoms	Mother report of child anxiety symptoms on the PROMIS Parent Proxy Short Form GenPop v3.0 - Anxiety 8a. Raw scores on the measure range from 8-40, with higher scores indicating more anxiety symptoms.	T2 (3 months post-baseline) and T3 (6 months post-baseline)
Child asthma control	Dichotomized score on the Child Asthma Control Test where ACT ≥ 20 indicates controlled asthma and ACT less than 20 indicates uncontrolled asthma.	T2 (3 months post-baseline), T3 (6 months post-baseline)
Asthma management	Summary score on the Family Asthma Management System Scale (FAMSS), a clinical interview that assesses how well the family system manages the asthma of the child. The interview is recorded and rated on eight 9-point subscales that tap the various domains of asthma management, with higher scores indicating better management.	T2 (3 months post-baseline)
Reach	The number and proportion of eligible mothers recruited into the study	T1 (Baseline)
Feasibility	Percentage of mothers who complete at least 7 sessions of the intervention (Enhanced IPT-B)	T2 (3 months post-baseline)
Staff-reported implementation outcomes	Semi-structure qualitative interviews with asthma clinic staff and leadership to assess adoption, acceptability, and maintenance of the intervention.	At the end of year 2
Satisfaction	Semi-structured interviews will be conducted with at least one third of Enhanced IPT-B participants to assess intervention satisfaction.	T3 (6 months post-baseline)

Collaborators and Investigators

• Sponsor: Children's National Research Institute
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Rachel Margolis, PhD, MSW, Children's National Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: STUDY00001112; K01MD018636 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual and aggregate survey data (including raw and recoded data) will be shared. The data from intervention sessions with Enhanced IPT-B participants will not be shared. Summarized aggregated deidentified data from the implementation-focused process evaluation will be made available for sharing.
• IPD Sharing Time Frame: The study data will be released and made available approximately 12 months following the conclusion of the award period. Datasets underlying publications will be shared at or prior to initial publication date. Data we do not publish on will be shared before the end of this award. Study data deposited in the DSDR repository will be available to the research community permanently.
• IPD Sharing Access Criteria: All shared study materials, data, and metadata will be made publicly available to researchers external to the project free of charge through the Data Sharing for Demographic Research (DSDR) digital data repository hosted by the ICPSR. The data will be findable in the DSDR repository and identifiable using a study digital object identifier provided by ICPSR.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No