Status:
COMPLETED
Improving Preterm Outcomes by Safeguarding Maternal Mental Health
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
Tufts Medical Center
Beth Israel Deaconess Medical Center
Conditions:
Depression
Child Development
Eligibility:
All Genders
Up to 64 years
Phase:
NA
Brief Summary
The investigators' goal is to optimize the developmental outcomes of preterm infants by preventing depression and improving functioning among their mothers during the critical first year of life. The ...
Detailed Description
Preterm infants are born at biological risk for poor health and developmental outcomes; and those born to low-income families face additional social risks known to further interfere with healthy child...
Eligibility Criteria
Inclusion
- Baby is 26-34 weeks gestational age
- Baby qualifies to receive Medicaid
- Mother comfortable in English or Spanish
- Singleton or twin gestation
- Baby is expected to survive
Exclusion
- Mother in major depressive episode or endorses suicidality
- Mother with psychosis or otherwise cognitively limited
- Mother with known active substance use; custody of infant uncertain
- Infant is critically ill
- Triplets or higher number gestation
- Mother who is enrolled in another study receiving the same intervention that we are testing
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT01892982
Start Date
June 1 2013
End Date
July 31 2018
Last Update
August 28 2018
Active Locations (4)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Boston Medical Center
Boston, Massachusetts, United States, 02118
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215