Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brown University
Study ID
NCT04092010
Status
Recruiting
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Conditions

  • Maternal Depression

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Problem-solving education (PSE) — BEHAVIORAL
    PSE will be offered to mothers with low baseline depressive symptoms (the first, preventive step of the SCI). PSE participants will have their symptoms assessed at each session and will convert to Engagement Sessions if they meet pre-specified 'step up' criteria.
  • Engagement sessions — BEHAVIORAL
    Engagement sessions will be offered to mothers with greater depressive symptoms to link them to formal mental health services (the second, referral step of the SCI)
  • Usual care — BEHAVIORAL
    Normal services provided children and their mothers in Head Start

Study Details

Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness.

Key Dates

Start date
Aug 16, 2023
Status verified
Dec 2024
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
388 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Stepped-care intervention (SCI) group
    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.
  • Active Comparator: Usual care control group
    Families in the control group will receive usual Head Start services.

Primary Outcome Measure

Change in incident rates of moderate to severe maternal depressive symptoms based on the QIDS [ Time Frame: Baseline, 2, 4, 6, 8, 10, 12 months follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical CenterBostonMassachusetts02119
Amy Yule, MD

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By research site
Boston Medical Center· Boston, MA

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