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Active, not recruiting Not applicable Interventional

Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

ClinicalTrials.gov ID: NCT04092010

Public ClinicalTrials.gov record NCT04092010. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 1:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04092010
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Brown University
Other
Enrollment
388 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
Not listed
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 16, 2023 (Actual)
Primary completion
Apr 30, 2028 (Estimated)
Completion
Apr 30, 2028 (Estimated)
Last update posted
Aug 6, 2026

2023 – 2028

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Boston Medical Center Boston Massachusetts 02119 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04092010, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 6, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04092010 live on ClinicalTrials.gov.

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