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Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
NCT04092010 · View on ClinicalTrials.gov ↗
Study Summary
Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness.
Conditions Studied
Interventions
- BEHAVIORAL Usual care
- BEHAVIORAL Problem-solving education (PSE)
- BEHAVIORAL Engagement sessions
Study Locations (1)
Massachusetts
- Boston Medical Center — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2023-08-16 |
| Est. Completion | 2028-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04092010
The ClinicalTrials.gov registry entry for NCT04092010 describes a study currently listed as recruiting. 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 388 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 268 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 3 interventions — of which Usual care 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: NCT04092010 reports 1 study location 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 NCT04092010 about?
NCT04092010 is a clinical study titled "Improving Preschool Outcomes by Addressing Maternal Depression in Head Start". Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Bo...
What is the current status of trial NCT04092010?
This trial is currently recruiting. It is a NA study. The enrollment target is 388 participants. The study started on 2023-08-16. Estimated completion is 2028-04-30.
What conditions does trial NCT04092010 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 NCT04092010?
The interventions under investigation include: Usual care (BEHAVIORAL), Problem-solving education (PSE) (BEHAVIORAL), Engagement sessions (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04092010?
This trial is sponsored by Brown University, which has 268 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04092010 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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