Testing the Effectiveness and Implementation of an Evidence-Based Maternal Depression Treatment in an Urban Pediatric Asthma Clinic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maternal depressive symptoms
研究概览
简要总结
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:
- Does Enhanced IPT-B decrease maternal depressive symptoms?
- Does Enhanced IPT-B improve child asthma management and health outcomes (exacerbations, symptoms, control)?
- What are the preliminary implementation outcomes of delivering Enhanced IPT-B in an urban pediatric asthma clinic?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •<18 years old for the duration of the 6-month study period
- •Publicly insured
- •Physician-diagnosed persistent asthma
排除标准
- •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
- •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
研究组 & 干预措施
Enhanced IPT-B
Enhanced Brief Interpersonal Psychotherapy
干预措施: Enhanced Brief Interpersonal Psychotherapy (Behavioral)
Supplemented Usual Care
Short-term care coordination
干预措施: Supplemented Usual Care (Behavioral)
结局指标
主要结局
Maternal depressive symptoms
时间窗: T2 (3 months post-baseline)
≥ 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.
次要结局
- Clinically significant maternal depressive symptoms(T2 (3 months post-baseline))
- Child asthma exacerbations(T3 (6 months post-baseline))
- Child asthma symptoms(T2 (3 months post-baseline), T3 (6 months post-baseline))
- Maintenance(T3 (6 months post-baseline))
- Acceptability(T2 (3 months post-baseline))
- Maternal anxiety symptoms(T2 (3-months post-baseline) and T3 (6months post-baseline))
- Maternal PTSD symptoms(T2 (3 months post-baseline) and T3 (6 months post-baseline))
- Child depressive symptoms(T2 (3 months post-baseline) and T3 (6 months post-baseline))
- Feasibility(T2 (3 months post-baseline))
- Child anxiety symptoms(T2 (3 months post-baseline) and T3 (6 months post-baseline))
- Child asthma control(T2 (3 months post-baseline), T3 (6 months post-baseline))
- Asthma management(T2 (3 months post-baseline))
- Reach(T1 (Baseline))
- Satisfaction(T3 (6 months post-baseline))
- Staff-reported implementation outcomes(At the end of year 2)