Clinical trial NCT01892982: Improving Preterm Outcomes by Safeguarding Maternal Mental Health
Official title: Improving Preterm Outcomes by Safeguarding Maternal Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Child Development
Keywords: Maternal Depression
Preterm Birth
Preterm Outcomes
Child Development
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Tufts Medical Center
name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-07-08
Enrollment: 325
Sex: ALL
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of major depressive episode and depressive symptom trajectories
timeFrame: one year
measure: General Functioning
timeFrame: one year
Secondary outcomes:
measure: Caregiver burden, mastery and social support
timeFrame: one year
measure: Adherence to recommended NICU follow-up care
timeFrame: one year
measure: Parent-child interaction
timeFrame: one year
measure: Socio-emotional functioning
timeFrame: one year
measure: Cognitive functioning
timeFrame: one year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Michael Silverstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: