The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic
Purpose
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 aged 4-11 years 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
- Asthma in Children
- Depression
Eligibility
- Eligible Ages
- Over 4 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 ≥ 10 during standardized screening at the child with asthma's clinic visit Child: - Ages 4-11 years - 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) 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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Enhanced IPT-B |
Enhanced Brief Interpersonal Psychotherapy |
|
|
Active Comparator Supplemented Usual Care |
Short-term care coordination |
|
Recruiting Locations
Children's National and nearby locations
Washington, District of Columbia 20010
More Details
- NCT ID
- NCT06623981
- Status
- Recruiting
- Sponsor
- Children's National Research Institute
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 aged 4-11 years with asthma. Mothers with clinically significant depressive symptoms (PHQ-9 ≥ 10) 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.