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Problem-Solving Education for Maternal Depression

N/A

Recruiting

Led By Michael Silverstein, MD MPH

Research Sponsored by Brown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2, 4, 6, 8, 10, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a stepped-care intervention (with components that help both prevent & treat depression) can help a broad population base in MA.

Who is the study for?

This trial is for mothers of children aged 0-5 enrolled in Head Start programs, who will continue to receive services for at least a year. Participants must report feelings of depression or loss of pleasure and be Medicaid beneficiaries. They should also speak English or Spanish.

What is being tested?

The study tests a stepped-care intervention (SCI) aimed at preventing and managing maternal depression within Head Start centers. It includes problem-solving education (PSE), engagement sessions, and usual care, with the approach tailored to the severity of symptoms.

What are the potential side effects?

Both problem-solving education and engagement sessions have been previously tested and are considered safe with supportive evidence from randomized trials. No specific side effects are mentioned as they relate more to educational interventions rather than medical treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2, 4, 6, 8, 10, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2, 4, 6, 8, 10, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 4, 6, 8, 10, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in incident rates of moderate to severe maternal depressive symptoms based on the QIDS

Change in the mean maternal depressive symptoms based on the QIDS

Secondary study objectives

Behavioral Activation for Depression

Bracken School Readiness Assessment

Burden of illness for depression

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Stepped-care intervention (SCI) groupExperimental Treatment2 Interventions

In the SCI group, mothers with low baseline depressive symptoms are offered the problem-solving education (PSE) prevention intervention, and mothers with greater depressive symptoms are offered Engagement Sessions.

Group II: Usual care control groupActive Control1 Intervention

Families in the control group will receive usual Head Start services.

Do I qualify?Apply below to find out