跳至主要内容
临床试验/NCT00536159
NCT00536159已完成不适用

Improving the Health and Development of Low-Income Pregnant Women

Michigan State University2 个研究点 分布在 1 个国家目标入组 613 人开始时间: 1997年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
613
试验地点
2
主要终点
mastery

研究概览

简要总结

Our objective was to test whether there were advantages to Nurse-CHW team home visiting designed to combine the strengths of both visitors, with a focus on maternal stress and mental health, when compared with standard of Community Care (CC) that included professional home visitors in a state-sponsored Medicaid program. We conducted the study under usual community conditions in a population of women eligible for state-sponsored Medicaid programs. We predicted that during pregnancy and infancy, women in the Nurse-CHW team intervention would report 1) less perceived stress; 2) fewer depressive symptoms; and 3) increased levels of psychosocial resources (self-esteem, mastery, and social support) than women in CC. Benefits were expected to be most pronounced for women with low psychosocial resources and high stress at enrollment.

详细描述

Impoverished pregnant and parenting women have greater exposure to environmental stress with adverse effects for their own mental and physical health that may have long term consequences for their children's health and development. The mental health consequences of stress are pervasive in low income pregnant women and mothers with almost half screening positive for depressive symptoms and a quarter meeting diagnostic criteria for major or minor depression. While national home visiting models have demonstrated improvement in health, developmental, and parenting outcomes for women willing to participate, they have had less success in reducing depressive symptoms during pre and postnatal periods, and often programs struggle to engage women with unmet mental health needs.

We conducted a community-based, multi-site, randomized, controlled trial that included longitudinal assessment on five occasions during pregnancy and infancy to determine temporal program effects. We used a CC comparison group because Medicaid insured women in Michigan are eligible for home visiting through enhanced prenatal and infant services, and our goal was to determine if there was any advantage to the team approach when compared to community implementation of the state-sponsored home visiting program.

Pregnant women, who telephoned one of five public clinics in Kent County, Michigan, a county that includes urban (Grand Rapids) and rural areas, were contacted and invited to participate in the trial. We enrolled women considered harder to reach with cultural, language, and literacy barriers to participation and with chronic or current medical problems-populations traditionally served by state-sponsored programs. Participation was not dependent on women coming to a research or health facility, participating in prenatal or child health care or the enhanced services, having reliable transportation, consistent phone service, or stable housing.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Medicaid eligible
  • residency in the county and no plans to move within 18 months
  • at least 16 years of age
  • speaks Spanish or English

排除标准

  • no pre-existing relationship with a home visiting nurse
  • no diagnosis or treatment for a pre-existing mental health condition within the last two years

结局指标

主要结局

mastery

时间窗: <24 weeks gestation to 12 months postbirth

self esteem

时间窗: <24 weeks gestation to 12 months post birth

depressive symptoms

时间窗: <24 weeks gestation to 12 months post birth

perceived stress

时间窗: <24 weeks gestation to 12 months post birth

social support

时间窗: <24 weeks gestation to 12 months postbirth

次要结局

  • Medicaid (maternal and infant)and program costs(<24 weeks gestation to 12 months)
  • maternal-infant interaction(6 and 12 months postbirth)
  • health risk behaviors (smoking, drug, alcohol)(<24 weeks gestation to 12 months postbirth)
  • infant motor, mental development(6 and 12 months postbirth)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验