Preventing Maternal Depression In Head Start
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Maternal depression disproportionately affects low-income and minority women, and has
      profound negative impacts on their children. The investigators are conducting a randomized
      trial of a systems approach to identify mothers at risk for depression in Head Start - a
      federally funded early learning program for children of low-income families - and to provide
      an on-site intervention to prevent or alleviate depressive symptoms; improve functioning;
      and, where appropriate, proactively link mothers to more definitive mental health services.
    

Detailed description: 
      This study is one component of a series of studies that aims to develop a comprehensive
      system of maternal depression prevention and management within Head Start. In our March 2014
      review of the CT.gov protocol, we synchronized it with our institution's IRB protocol, which
      had been modified based on how the individual studies within this series relate to one
      another. Specifically, the original IRB protocol combined two studies into one: a 'main'
      depression prevention trial (n=230, R01MH091871), and a small adjunct pilot aimed at
      referring those with symptoms of major depression to further care (n=60). Thus, the original
      CT.gov protocol included subjects both at risk for depression and with symptoms consistent
      with major depression. When the latter pilot study subsequently received external funding, we
      separated the two studies into two IRB protocols, and thus have adjusted our CT.gov protocol
      to the appropriate sample size of 230, and indicated symptoms of major depression as an
      exclusion criterion for the prevention trial. Because Major Depressive Episode was
      inadvertently listed as a primary outcome measure for the prevention trial (and PTSD and
      Anxiety as secondary outcome measures), we have removed them as such and listed it under
      'other' outcomes, thereby aligning the CT.gov protocol with the statistical analysis plan of
      the original grant application and IRB protocol. Lastly, we corrected administrative errors
      in the study's projected end date and masking design.
    

Intervention name(s): Problem Solving Education and Activated Referral to Care
Intervention type(s): Behavioral
Intervention description(s): The intervention represents an integrated identification and intervention system based on the evidence-based construct of screening, brief intervention, and referral to treatment (SBIRT). Within the comprehensive case management services of Head Start, eligible women will be randomized to receive either usual care or the Head Start-based intervention. In our intervention, mothers at risk for depression will receive a problem-solving intervention; depression symptom monitoring; and an "Activated" referral to more definitive services for those who have worsening symptoms over time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention