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?
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
Children's National Hospital
Washington D.C., District of Columbia, United States
RECRUITINGMaternal 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.
Time frame: T2 (3 months post-baseline)
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.
Time frame: T2 (3 months post-baseline)
Child asthma exacerbations
Number of asthma exacerbations requiring steroids in the past 6 months
Time frame: T3 (6 months post-baseline)
Child asthma symptoms
Mother-reported number of child asthma symptom-free days during the prior 14 days
Time frame: T2 (3 months post-baseline), T3 (6 months post-baseline)
Maintenance
Percentage of enrolled mothers who remain in the study
Time frame: T3 (6 months post-baseline)
Acceptability
Mean treatment satisfaction survey score on the Client Satisfaction Questionnaire
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: T2 (3 months post-baseline)
Reach
The number and proportion of eligible mothers recruited into the study
Time frame: T1 (Baseline)
Feasibility
Percentage of mothers who complete at least 7 sessions of the intervention (Enhanced IPT-B)
Time frame: T2 (3 months post-baseline)
Satisfaction
Semi-structured interviews will be conducted with at least one third of Enhanced IPT-B participants to assess intervention satisfaction.
Time frame: T3 (6 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.
Time frame: At the end of year 2
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