Clinical trial NCT06623981: The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic
Official title: Testing the Effectiveness and Implementation of an Evidence-Based Maternal Depression Treatment in an Urban Pediatric Asthma Clinic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Depression
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?

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.

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 ≥ 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

Primary outcomes:
measure: Maternal depressive symptoms
timeFrame: T2 (3 months post-baseline)
Secondary outcomes:
measure: Clinically significant maternal depressive symptoms
timeFrame: T2 (3 months post-baseline)
measure: Child asthma exacerbations
timeFrame: T3 (6 months post-baseline)
measure: Child asthma symptoms
timeFrame: T2 (3 months post-baseline), T3 (6 months post-baseline)
measure: Maintenance
timeFrame: T3 (6 months post-baseline)
measure: Acceptability
timeFrame: T2 (3 months post-baseline)
measure: Maternal anxiety symptoms
timeFrame: T2 (3-months post-baseline) and T3 (6months post-baseline)
measure: Maternal PTSD symptoms
timeFrame: T2 (3 months post-baseline) and T3 (6 months post-baseline)
measure: Child depressive symptoms
timeFrame: T2 (3 months post-baseline) and T3 (6 months post-baseline)
measure: Child anxiety symptoms
timeFrame: T2 (3 months post-baseline) and T3 (6 months post-baseline)
measure: Child asthma control
timeFrame: T2 (3 months post-baseline), T3 (6 months post-baseline)
measure: Asthma management
timeFrame: T2 (3 months post-baseline)
measure: Reach
timeFrame: T1 (Baseline)
measure: Feasibility
timeFrame: T2 (3 months post-baseline)
measure: Satisfaction
timeFrame: T2 (3 months post-baseline)
measure: Staff-reported implementation outcomes
timeFrame: At the end of year 2
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Rachel Margolis, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References: