Improving Preterm Outcomes by Safeguarding Maternal Mental Health



Status:Completed
Conditions:Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any - 64
Updated:8/30/2018
Start Date:June 2013
End Date:July 31, 2018

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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.

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 development. In its 2006 report, Preterm Birth, the Institute of Medicine
(IOM) stated the public health importance of optimizing the developmental outcomes of preterm
infants, and specifically called for novel postnatal intervention strategies to accomplish
this goal. Our proposed strategy is based on the premise that preventing maternal depression
- and optimizing maternal functioning in specific domains that mediate the relationship
between maternal depression and adverse child effects - will ultimately improve the
developmental outcomes of this vulnerable child population.

Problem Solving Education (PSE) is a cognitive behavioral strategy that aims to impart
recipients with skills to reduce the impact of stress on personal functioning, and thereby
prevent depression. The present project is a randomized trial of a 6-session intervention
based on PSE. the investigators aim to enroll 325 mother-infant dyads in four NICUs - Boston
Medical Center, Tufts Medical Center, Beth Israel Deaconess Medical Center, and Brigham and
Womens Hospital. Over 12-months of follow-up, the investigators will assess the effects of
PSE on a series of outcome measures for mothers, a series of measures that represent risk
mechanisms by which maternal depression is theorized to impact young children, and a series
of child functioning measures.

1. Primary aims. Regarding outcomes for mothers, the investigators aim to:

1. Decrease the incidence of major depressive episode (MDE) and improve depressive
symptom trajectories during the first postpartum year; and

2. Improve general and parental functioning, as measured by valid and reliable scales.

2. Secondary aims. Regarding risk mechanisms and child outcomes, the investigators aim to:

1. Improve mothers' sense of mastery, and decrease their caregiver burden and social
isolation;

2. Improve adherence to evidence-based quality indicators for NICU follow-up care;

3. Improve maternal sensitivity and mother-child interaction patterns; and

4. Improve infant social engagement, emotionality, and cognitive functioning.

3. Exploratory aims. the investigators will explore the role of a brief set of potential
intervention moderators:

1. On the infant level: severity of infant illness.

2. On the maternal and family level: maternal trauma history, extended family
functioning, and intervention adherence.

Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
4
sites
Boston, Massachusetts 02118
Principal Investigator: Michael Silverstein, MD, MPH
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Elisabeth Schainker, MD
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Michael Prendergast, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Dmitry Dukhovny, MD, MPH
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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