Protocol for a randomized controlled trial of the Mommy&Me study: A multi-modal approach to address social determinants of health and mental health among low-income Black perinatal populations

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-04-21 DOI:10.1016/j.conctc.2025.101489

Huynh-Nhu Le , Nickie Andescavage , Jennifer M. Keller , Maariya M. Bassa , Aimee L. Danielson , Diedtra Henderson , Shanae Bond , Nandi Mjenga , Stephanie Wells , Patricia Quinn , Catherine Limperopoulos

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Abstract

Background

Mental health disorders, including stress, anxiety, and depression, are the most common complications during pregnancy, with significant racial disparities in prevalence and access to care. Low-income Black/African American/of African descent (Black) individuals are at greater risk for perinatal mental health issues and face more obstacles to care due to a variety of barriers, including poor implementation of screening protocols, stigma, adverse experiences of social determinants of health, and distrust of healthcare systems. These disparities are particularly striking in Washington, DC, and worsened during the COVID-19 pandemic.

Methods

This study has two aims: (1) to refine an individualized plan to integrate patient navigation and a culturally adapted cognitive-behavioral (CBT) prevention and treatment intervention for low-income Black pregnant women; and (2) to determine the effectiveness of multiple interventions: patient navigation, culturally adapted CBT, and/or peer support groups versus usual care for pregnant individuals at subthreshold and threshold risk for prenatal stress, depression and/or anxiety in a two-arm prospective longitudinal randomized controlled study. Outcomes will be tracked from pregnancy through 12 months postpartum, assessing maternal mental health, engagement with the intervention, healthcare experiences and utilization, and infant outcomes.

Conclusions

If found to be efficacious, results will help develop scalable, culturally relevant interventions aimed at reducing racial disparities in maternal mental health care and improving health outcomes for both mothers and infants. Trial registration: ClinicalTrials.gov ID NCT05345834.

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妈妈和我研究的随机对照试验方案：解决低收入黑人围产期人群健康和心理健康的社会决定因素的多模式方法

心理健康障碍，包括压力、焦虑和抑郁，是怀孕期间最常见的并发症，在患病率和获得护理方面存在显著的种族差异。低收入黑人/非裔美国人/非洲人后裔（黑人）个体面临围产期心理健康问题的更大风险，由于各种障碍，包括筛查方案执行不当，污名化，健康社会决定因素的不良经历以及对医疗保健系统的不信任，他们面临更多的护理障碍。这些差异在华盛顿特区尤为明显，在2019冠状病毒病大流行期间进一步恶化。方法本研究有两个目的：(1)为低收入黑人孕妇制定个性化的患者导航和文化适应性认知行为（CBT）预防和治疗干预方案；(2)确定多种干预措施的有效性：在一项两组前瞻性纵向随机对照研究中，患者导航、文化适应性CBT和/或同伴支持团体与产前压力、抑郁和/或焦虑的阈下和阈下风险孕妇个体的常规护理。结果将被跟踪从怀孕到产后12个月，评估产妇的心理健康，参与干预，医疗保健经验和利用，以及婴儿的结果。结论：如果发现有效，结果将有助于开发可扩展的、与文化相关的干预措施，旨在减少孕产妇心理保健中的种族差异，改善母婴的健康结果。试验注册：ClinicalTrials.gov ID NCT05345834。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.