Clinical trial NCT01298804: Preventing Maternal Depression In Head Start
Official title: Preventing Maternal Depression In Head Start
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Head Start and Early Head Start Programs in Action for Boston Community Development Incorporated
First posted: 2011-02-18
Enrollment: 230
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

* High suicidal ideation
* Cognitive limitation
* Psychosis
* No known risks for depression
* Symptoms reflecting major depressive episode

Primary outcomes:
measure: Depression Symptoms
timeFrame: 2 months
measure: Depression Symptoms
timeFrame: 4 months
measure: Depression Symptoms
timeFrame: 6 months
measure: Depression Symptoms
timeFrame: 8 months
measure: Depression Symptoms
timeFrame: 10 months
measure: Depression Symptoms
timeFrame: 12 months
measure: Problem Solving Skills
timeFrame: 6 months
measure: Problem Solving Skills
timeFrame: 12 months
Secondary outcomes:
measure: Social functioning
timeFrame: 6 months
measure: Parent functioning/stress
timeFrame: 6 months
measure: Head Start attendance
timeFrame: 12 months
measure: Receipt of Mental Health Services
timeFrame: 12 months
measure: Social functioning
timeFrame: 12 months
measure: Parent functioning/stress
timeFrame: 12 months
measure: Child Behavior
timeFrame: 6 months
Other outcomes:
measure: Major Depressive Episode
timeFrame: 12 months
measure: Post Traumatic Stress Disorder
timeFrame: 12 months
measure: Anxiety
timeFrame: 12 months
Locations:
city: Boston
country: United States
facility: ABCD Head Start
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Michael Silverstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silverstein M, Cabral H, Hegel M, Diaz-Linhart Y, Beardslee W, Kistin CJ, Feinberg E. Problem-Solving Education to Prevent Depression Among Low-Income Mothers: A Path Mediation Analysis in a Randomized Clinical Trial. JAMA Netw Open. 2018 Jun 1;1(2):e180334. doi: 10.1001/jamanetworkopen.2018.0334.
citation: Silverstein M, Diaz-Linhart Y, Cabral H, Beardslee W, Broder-Fingert S, Kistin CJ, Patts G, Feinberg E. Engaging Mothers With Depressive Symptoms in Care: Results of a Randomized Controlled Trial in Head Start. Psychiatr Serv. 2018 Nov 1;69(11):1175-1180. doi: 10.1176/appi.ps.201800173. Epub 2018 Sep 26.
citation: Silverstein M, Diaz-Linhart Y, Cabral H, Beardslee W, Hegel M, Haile W, Sander J, Patts G, Feinberg E. Efficacy of a Maternal Depression Prevention Strategy in Head Start: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Aug 1;74(8):781-789. doi: 10.1001/jamapsychiatry.2017.1001.