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Problem Solving Education and Neonatal Intensive Care Unit (NICU) Mothers

Empowering Low Income Mothers With Preterm Infants: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01214967
Acronym
Project Solve
Enrollment
50
Registered
2010-10-05
Start date
2008-10-31
Completion date
2010-06-30
Last updated
2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Depression

Keywords

risk factors for maternal depression

Brief summary

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.

Interventions

psycho-educational intervention

Sponsors

Tufts Medical Center
CollaboratorOTHER
Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Baby is ≤ 33 weeks gestational age and is expected to survive. * Baby qualifies to receive WIC * Mother is comfortable in English or Spanish.

Exclusion criteria

* Mother has psychosis * Mother endorses suicidal ideation * Custody of baby is uncertain * Mother is cognitively limited, per judgment of NICU attending physician * Baby is critically ill, per judgment of NICU attending physician

Design outcomes

Primary

MeasureTime frame
Maternal Depressive Symptoms6 months

Secondary

MeasureTime frame
Health Care Supervision Schedule for Children6 months
Immunization Schedule for Children6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026