Preventing Maternal Depression In Head Start
| Status: | Completed |
|---|---|
| Conditions: | Depression |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 15 - 64 |
| Updated: | 8/10/2016 |
| Start Date: | February 2011 |
| End Date: | July 2016 |
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.
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.
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.
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.
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
We found this trial at
2
sites
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