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

Overview

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?

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Maternal depressive symptoms [Time frame: T2 (3 months post-baseline)]

Secondary outcome measures (12)

• Clinically significant maternal depressive symptoms [Time frame: T2 (3 months post-baseline)]
• Child asthma exacerbations [Time frame: T3 (6 months post-baseline)]
• Child asthma symptoms [Time frame: T2 (3 months post-baseline), T3 (6 months post-baseline)]
• Maintenance [Time frame: T3 (6 months post-baseline)]
• Acceptability [Time frame: T2 (3 months post-baseline)]
• Maternal anxiety symptoms [Time frame: T2 (3-months post-baseline) and T3 (6months post-baseline)]
• Maternal PTSD symptoms [Time frame: T2 (3 months post-baseline) and T3 (6 months post-baseline)]
• Child depressive symptoms [Time frame: T2 (3 months post-baseline) and T3 (6 months post-baseline)]
• Child anxiety symptoms [Time frame: T2 (3 months post-baseline) and T3 (6 months post-baseline)]
• Child asthma control [Time frame: T2 (3 months post-baseline), T3 (6 months post-baseline)]
• Asthma management [Time frame: T2 (3 months post-baseline)]
• Reach [Time frame: T1 (Baseline)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Children's National Hospital — Washington D.C.

Identifiers

NCT: NCT06623981 · STUDY00001112 · K01MD018636

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗