Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
This study aims to help mothers in Head Start programs who are experiencing symptoms of depression, which can also benefit their children. It tests a "stepped-care intervention" (SCI) that offers different levels of support based on a mother's needs. If you have lower depressive symptoms, you might receive Problem-solving education (PSE). If your symptoms are more significant, you'll be offered Engagement sessions to connect you with mental health services. The study will track changes in mothers' depressive symptoms over 12 months to see how well these interventions work. This study is for women who are mothers of children aged 0-5 in Head Start and speak English or Spanish. It is not for mothers with suicidal thoughts or cognitive limitations. The study plans to enroll 388 participants.
- Study design
- This is an interventional study involving 388 participants. It tests a stepped-care intervention with different levels of support.
- What's involved
- Participants will have their depressive symptoms assessed at baseline and at 2, 4, 6, 8, 10, and 12 months. The specific number of sessions for Problem-solving education or Engagement sessions is not detailed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after starting the intervention.
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Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
At a glance
Conditions
NCT04092010
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Boston Medical Center
Boston, Massachusettsno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Emily Feinberg, ScD CPNP · PRINCIPAL_INVESTIGATOR · Brown University
- Michael Silverstein, MD · PRINCIPAL_INVESTIGATOR · Brown University
- Amy Yule, MD · PRINCIPAL_INVESTIGATOR · Boston Medical Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Inclusion
Exclusion
What this trial measures
- Change in incident rates of moderate to severe maternal depressive symptoms based on the QIDSBaseline, 2, 4, 6, 8, 10, 12 months follow-up
The Quick Inventory of Depressive Symptoms (QIDS) will be used to assess the incidence of moderate to severe depressive symptom episodes, as defined by a QIDS score ≥ 11. The QIDS is a 16 item self-administered instrument with potential responses for each item of 0 to 3. Higher scores are associated with greater depressive symptoms.
- Change in the mean maternal depressive symptoms based on the QIDSBaseline, 2, 4, 6, 8, 10, 12 months follow-up
The Quick Inventory of Depressive Symptoms will be used to assess depressive symptoms. The QIDS is a 16 item self-administered instrument with potential responses for each item of 0 to 3. Higher scores are associated with greater depressive symptoms. The mean QIDS scores will be calculated for the baseline and each follow up period.