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NCT01182363 · ClinicalTrials.gov registry record · NA
Reducing Risk After an Adverse Pregnancy Outcome
A NA study, sponsored by Boston Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 188
- Enrollment target
NCT01182363 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 188 participants.
The verdict
NCT01182363, a NA study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 188 participants
- Enrollment target
Study Summary
This application to the Boston University Medical Center Institutional Review Board outlines a research plan devoted to identifying and managing maternal depression in Early Intervention (EI). The target population is women who's children are enrolled in early intervention who have experienced an adverse pregnancy outcome, defined as the birth of a child who was born prematurely, low birth weight, or with birth defects. Early intervention provides developmental services to the state's birth to three population under the Part C of the Individuals with Disabilities Act (IDEA). Our intervention strategy involves the identification of mothers whose children receive early intervention services and who, themselves, are at risk for depression. Eligible mothers will be offered a preventative intervention that involves the principles of Problem Solving Treatment (PST). Problem Solving Treatment is a brief skills-building psychotherapeutic intervention that focuses on specific daily problems, and applies to these problems a structured approach to finding and evaluating solutions. This study will be a parallel group randomized control trial (RCT) of 188 mother-child dyads. Mothers in the intervention group will receive 6 sessions of Problem Solving Treatment, which will be referred to as Problem Solving Education (PSE) in this application. The women in the control site will receive usual care. Problem Solving Education interventionists (Problem Solving Educators or PS Educators) will conduct Problem Solving Education with mothers of children who receive early intervention services through Thom Child and Family Services, Bay Cove Early Intervention program, South Shore Mental Health (Step One Early Intervention), and Meeting Street Early Intervention with an enrollment goal of 188 mothers. In addition to engaging in Problem Solving Education sessions, mothers who agree to participate in the study will meet with research staff to complete 1)baseline assessment measures at study
Interventions
- BEHAVIORAL Project Solve Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01182363
The ClinicalTrials.gov registry entry for NCT01182363 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Project Solve Education is the first listed.
NCT01182363 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01182363 about?
NCT01182363 is a clinical study titled "Reducing Risk After an Adverse Pregnancy Outcome". This application to the Boston University Medical Center Institutional Review Board outlines a research plan devoted to identifying and managing maternal depression in Early Intervention (EI). The target population is women who's children are enrolled in early intervention who have experienced an ad...
What is the current status of trial NCT01182363?
This trial is currently completed. It is a NA study. The enrollment target is 188 participants. The study started on 2010-08. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01182363?
The interventions under investigation include: Project Solve Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT01182363?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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