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Problem Solving Education and Neonatal Intensive Care Unit (NICU) Mothers
NCT01214967 · View on ClinicalTrials.gov ↗
Study 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 100,00
Conditions Studied
Interventions
- BEHAVIORAL Problem Solving Education
Study Locations (2)
Massachusetts
- Boston Medical Center — Boston
- Tufts Medical Center — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-10 |
| Est. Completion | 2010-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01214967
The ClinicalTrials.gov registry entry for NCT01214967 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 192 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Maternal Depression appearing as the primary indexed condition, and to 1 intervention — of which Problem Solving Education is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01214967 reports 2 study locations spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01214967 about?
NCT01214967 is a clinical study titled "Problem Solving Education and Neonatal Intensive Care Unit (NICU) Mothers". 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 ...
What is the current status of trial NCT01214967?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2008-10. Estimated completion is 2010-06.
What conditions does trial NCT01214967 study?
This clinical trial studies the following conditions: Maternal Depression. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01214967?
The interventions under investigation include: Problem Solving Education (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01214967?
This trial is sponsored by Boston Medical Center, which has 192 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01214967 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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