Improving Preterm Outcomes by Safeguarding Maternal Mental Health

Completed · Not applicable

Conditions studied: Depression, Child Development

In brief

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 investigators are conducting a randomized controlled trial of a replicable, lay-delivered intervention - the basic approach of which is to use an empirically-supported, cognitive behavioral strategy to help mothers solve their unique daily problems and address some of the predictable challenges to parenting a preterm infant.

Key facts

Study ID

NCT01892982

Run by

Boston Medical Center

People needed

325

Starts

2013-06-01

Expected to finish

2018-07-31

Last updated by the study team

2018-08-28

Who can join

Age: any, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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