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.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04092010

Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

Active, Not Recruiting
NAAll AgesInterventionalHealth services
Brown University
~388 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Problem-solving education (PSE)Engagement sessionsUsual care

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in incident rates of moderate to severe maternal depressive symptoms based on the QIDS
Measured over Baseline, 2, 4, 6, 8, 10, 12 months follow-up
+1 more outcome measured
Maternal Depression

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.

  • Emily Feinberg, ScD CPNP · PRINCIPAL_INVESTIGATOR · Brown University
  • Michael Silverstein, MD · PRINCIPAL_INVESTIGATOR · Brown University
  • Amy Yule, MD · PRINCIPAL_INVESTIGATOR · Boston Medical Center

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Mother of a 0 to 5-year-old Head Start child
Mother speaks English or Spanish

Exclusion

Mother with suicidal ideation
Mother with cognitive limitation
  • 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.