RecruitingNot ApplicableNCT04092010

Improving Preschool Outcomes by Addressing Maternal Depression in Head Start


Sponsor

Brown University

Enrollment

388 participants

Start Date

Aug 16, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study helps mothers enrolled in Head Start (a US preschool program for low-income families) who are experiencing depression. The goal is to treat maternal depression so that both mothers and their young children can thrive — because a parent's mental health has a big impact on a child's early development. **You may be eligible if...** - You are the mother of a child aged 0 to 5 who is enrolled in Head Start - You speak English or Spanish **You may NOT be eligible if...** - You are currently having thoughts of suicide - You have a cognitive limitation that would prevent participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALProblem-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.

BEHAVIORALEngagement 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)

BEHAVIORALUsual care

Normal services provided children and their mothers in Head Start


Locations(1)

Boston Medical Center

Boston, Massachusetts, United States

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NCT04092010


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