← Back to Search

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 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

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,672,409 Total Patients Enrolled

6 Trials studying Postpartum Depression

4,286 Patients Enrolled for Postpartum Depression

Brown UniversityLead Sponsor

456 Previous Clinical Trials

557,956 Total Patients Enrolled

1 Trials studying Postpartum Depression

250 Patients Enrolled for Postpartum Depression

Boston Medical CenterOTHER

384 Previous Clinical Trials

871,242 Total Patients Enrolled

1 Trials studying Postpartum Depression

231 Patients Enrolled for Postpartum Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still open slots available in this experiment for participants?

"This medical trial is currently enrolling, as per the latest information on clinicaltrials.gov. The study was initially posted in August 16th 2023 and saw its most recent update November 16th of that same year."

Answered by AI

How many participants are currently aiding in the data collection of this clinical experiment?

"Affirmative. Clinicaltrials.gov hosts data that demonstrates this medical investigation, which was originally published on the 16th of August 2023, is actively looking for participants. 388 volunteers must be sourced from 1 clinical site."

Answered by AI

What are the goals of this clinical trial?

"The primary outcome of this trial, which will be assessed at Baseline and the follow-up points of 2, 4, 6, 8 10 12 months is a shift in mean maternal depressive symptoms as measured by QIDS. Furthermore, we aim to measure Rate of participants engaged with care (defined as ≥ 1 visit for psychotherapy or pharmacotherapy with a behavioral health specialist/prescription for psychiatric medication from any medical practitioner.), Retention in Care rate (≥4 visits for psychotherapy or pharmacotherapy with a behavioural health spcialist/prescription for psychiatric medication), and Evidence-Based Care rate (psychotherpy or antidepressant med"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

2023. "Improving Preschool Outcomes by Addressing Maternal Depression in Head Start". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04092010.

All > Depression Boston