Preventing Maternal Depression In Head Start
- Conditions
- Depression
- Interventions
- Behavioral: Problem Solving Education and Activated Referral to Care
- Registration Number
- NCT01298804
- Lead Sponsor
- Boston Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 230
- Family enrolled in Head Start, and child expected to attend Head Start activities for at least 6 months of the 12-month follow-up period.
- Family without imminent plans to relocate
- Mother is comfortable in English or Spanish.
- Parent/guardian who has a child that attends Head Start
- Child attending Head Start and is between the ages 0-5
- Screen positive to 2-question depression screener (PHQ2), or have a past history of depression
- Ability to provide informed consent.
- Not suicidal
- High suicidal ideation
- Cognitive limitation
- Psychosis
- No known risks for depression
- Symptoms reflecting major depressive episode
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Problem Solving Education Problem Solving Education and Activated Referral to Care -
- Primary Outcome Measures
Name Time Method Depression Symptoms 12 months QIDS
Problem Solving Skills 12 months Social Problem Solving Inventory
- Secondary Outcome Measures
Name Time Method Social functioning 12 months Social Adjustment Scale- Self-report
Parent functioning/stress 12 months Parenting Stress Index, Perceived Stress Index
Receipt of Mental Health Services 12 months Head Start attendance 12 months Head Start records, analyzed as monthly absence rates
Child Behavior 6 months Teacher Version of Social Skills Rating System
Trial Locations
- Locations (2)
ABCD Head Start
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States