Stress Clinical Trial
Official title:
Improving the Health and Development of Low-Income Pregnant Women
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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