Preventing Maternal Depression In Head Start

Boston Medical Center (BMC)

Status

Completed

Conditions

Depression

Treatments

Behavioral: Problem Solving Education and Activated Referral to Care

Study type

Interventional

Funder types

Other

Identifiers

NCT01298804

R01MH091871

Details and patient eligibility

About

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.

Full 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.

Enrollment

230 patients

Sex

Female

Ages

15 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria