Maternal Depression Clinical Trial
Official title:
Empowering Low Income Mothers With Preterm Infants: a Randomized Controlled Trial
Premature infants are born at substantial risk for poor health and developmental outcomes,
which commonly include hearing and vision problems, developmental delays, and poor school
performance. Premature infants of low-income families face additional social risks known to
worsen these outcomes. The Institute of Medicine recognized this important public health
problem in its 2006 report, Preterm Birth, which argued for the need to improve the quality
of follow-up care for preterm infants discharged from the neonatal intensive care unit
(NICU). The underpinning of this proposal is that maternal depression - common among
families of premature infants - interferes with adherence to follow-up services, and (both
through this mechanism and directly) adversely impacts child health and development.
Conversely, alleviating depressive symptoms among these women represents a promising
strategy to improve adherence to NICU follow-up services and to improve the outcomes of this
vulnerable population.
This project aims to mitigate the adverse effects of maternal depression in this specific
high-risk population by testing a theory-based, parent-directed empowerment strategy, called
Problem Solving Education (PSE). In the past, similar strategies have been proven effective
for improving the mood and functioning of depressed adults, and for improving adherence to
medical treatment. However, they have never been tested in the setting of a parent-child
relationship or among families of premature infants.
This project involves a clinical trial of PSE among 50 low-income mothers at risk for
depression, who have premature infants in two Boston NICUs: Boston Medical Center and Tufts
Medical Center. The investigators aim to determine the impact of PSE on maternal depressive
symptoms and functioning, and adherence to child health supervision and immunization
schedules, vision screening, and early intervention evaluation for babies with suspected
developmental delays.
Approximately 100,000 children are born prematurely to low-income families each year.
Parent-directed PSE aims to improve outcomes for these children through the prevention
and/or attenuation of maternal depressive symptoms, as well as through family activation and
promotion of adherence to follow-up care. If successful, PSE could also provide the
cornerstone of a more generalizable empowerment strategy for families of children with
chronic medical conditions.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
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