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RECRUITING
NCT04092010
NA

Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

Sponsor: Brown University

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

388

Start Date

2023-08-16

Completion Date

2028-04-30

Last Updated

2024-12-11

Healthy Volunteers

No

Interventions

BEHAVIORAL

Problem-solving education (PSE)

PSE will be offered to mothers with low baseline depressive symptoms (the first, preventive step of the SCI). PSE participants will have their symptoms assessed at each session and will convert to Engagement Sessions if they meet pre-specified 'step up' criteria.

BEHAVIORAL

Engagement sessions

Engagement sessions will be offered to mothers with greater depressive symptoms to link them to formal mental health services (the second, referral step of the SCI)

BEHAVIORAL

Usual care

Normal services provided children and their mothers in Head Start

Locations (1)

Boston Medical Center

Boston, Massachusetts, United States