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NCT01214967 · ClinicalTrials.gov registry record · NA
Problem Solving Education and Neonatal Intensive Care Unit (NICU) Mothers
A NA study of Maternal Depression, sponsored by Boston Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT01214967: Completed NA study of Maternal Depression, sponsored by Boston Medical Center.
NCT01214967 is a NA study of Maternal Depression that has completed, run by Boston Medical Center. The registered enrollment target is 50 participants, below the 790-participant average among 5 other Maternal Depression trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01214967, a NA study of Maternal Depression, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
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 |
What the finished NCT01214967 record still lists
NCT01214967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 790-participant average among 5 other Maternal Depression trials with a reported enrollment target (94% lower).
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.
NCT01214967 reports a single indexed study location in Massachusetts.
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.
What interventions are being tested in trial NCT01214967?
The interventions under investigation include: Problem Solving Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT01214967?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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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