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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Behavioral Activation for Depression
Bracken School Readiness Assessment
Burden of illness for depression
+11 more

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.

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Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,977 Previous Clinical Trials
2,680,409 Total Patients Enrolled
6 Trials studying Postpartum Depression
3,959 Patients Enrolled for Postpartum Depression
Brown UniversityLead Sponsor
456 Previous Clinical Trials
557,868 Total Patients Enrolled
1 Trials studying Postpartum Depression
250 Patients Enrolled for Postpartum Depression
Boston Medical CenterOTHER
387 Previous Clinical Trials
873,532 Total Patients Enrolled
1 Trials studying Postpartum Depression
231 Patients Enrolled for Postpartum Depression
~259 spots leftby Apr 2028
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