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临床试验/NCT06575894
NCT06575894
Enrolling By Invitation
不适用

Can an Evidence-Based Mental Health Intervention be Implemented Into Preexisting Home Visiting Programs Using Implementation Facilitation?

Hackensack Meridian Health2 个研究点 分布在 1 个国家目标入组 1,750 人2026年4月1日

概览

阶段
不适用
干预措施
Standard Implementation
疾病 / 适应症
Mental Health Disorder
发起方
Hackensack Meridian Health
入组人数
1750
试验地点
2
主要终点
Adoption
状态
Enrolling By Invitation
最后更新
12天前

概览

简要总结

Depression and anxiety during and after pregnancy are common medical complications contributing to a rising maternal mortality rate. Home visiting programs can offer evidence-based interventions to improve mental health outcomes for a vulnerable pregnant population; however, barriers remain to achieving the full potential of these interventions. Our work will explore the impact of context on the implementation of a mental health intervention to provide action-based and impactful data that focuses on the lived experiences of the diverse populations served by home visiting programs in Iowa and Indiana.

详细描述

Perinatal mental health conditions are the most common complication of pregnancy and childbirth (1 in 8 women). When left untreated, perinatal depression and anxiety adversely affect the entire family with pregnancy complications and negative outcomes including preterm birth, impaired mother-infant bonding, impaired lactation, substance abuse, divorce, suicide, and infanticide. Despite this, significant gaps persist in the diagnosis and treatment of perinatal depression and anxiety. Preliminary research with stakeholders including community advisory boards, groups underreceiving mental health services, and state departments of health, demonstrates the importance of social support as a mechanism for improving perinatal depression, particularly in rural geographies. Home visiting programs (HVPs) can provide the social support needed to improve mental health outcomes in pregnant and postpartum women. Using the strategy of implementation facilitation, our proposed study will engage multilevel stakeholders (e.g., policymakers, front-line implementers, and intervention recipients) to adapt facilitation to integrate a maternal mental health intervention across two midwestern, rural states (Iowa and Indiana) with multiple HVP models. Given the complexity and heterogeneity of the contexts in which Mothers and Babies will be integrated, a three variable hybrid implementation-effectiveness-context trial will test the adapted facilitation strategy compared with implementation as usual (i.e., standard education) and will assess contextual factors related to the outcomes. Using an evidence-based implementation strategy that tailors implementation delivery to the needs of the specific populations and context may improve fidelity and adoption, particularly in rural states where residents have limited access to care. The immediate impact of this research will be to show whether adapted facilitation can improve the uptake and fidelity of a maternal mental health intervention like Mothers and Babies across multiple HVP models and thus positively affect depressive symptoms and perceived stress of recipients. Further, our implementation protocol can be used by other states to better integrate other evidence-based interventions into public health programs, leading to further improvements in maternal mental health, better access, and further reductions in adverse outcomes for mothers, children, and families.

注册库
clinicaltrials.gov
开始日期
2026年4月1日
结束日期
2029年2月28日
最后更新
12天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Affiliated as staff or volunteer with a home visiting program in Iowa or Indiana at the time of enrollment
  • Aged 18 years or older

排除标准

  • \- No exclusion criteria.

研究组 & 干预措施

Standard Implementation

Control arm home visitors will receive standard Mothers and Babies implementation support from their supervisors.

干预措施: Standard Implementation

HV Supervisor Refused

Home visitors outside the trial will receive no implementation support from their supervisors with respect to the Mothers and Babies intervention.

Adapted Facilitation

Home visitors in the adapted facilitation group will receive standard Mothers and Babies support plus adapted facilitation delivered by home visiting supervisors trained in adapted implementation facilitation.

干预措施: Adapted Facilitation

结局指标

主要结局

Adoption

时间窗: From date of recruitment assessed up to 12 months (3 months postpartum)

Percent of home visitors who deliver Mothers and Babies intervention to program recipients

Fidelity

时间窗: From date of recruitment assessed up to 12 months (3 months postpartum)

Percent of home visitors who deliver all 9 sessions of Mothers and Babies to program recipients

次要结局

  • Depressive Symptoms(From date of recruitment assessed up to 12 months (3 months postpartum))

研究点 (2)

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