Improving Preterm Outcomes by Safeguarding Maternal Mental Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression Child Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Problem Solving Education tailored to NICU

NICU-PSE integrates motivational interviewing and problem solving, with ongoing monitoring and linkage to mental health services for mothers with worsening depressive symptoms over time. The intervention is provided over six sessions, including three tailored, post-discharge sessions, which address issues common to families of preterm infants: caregiver burden, complexity of medical follow-up, and social reintegration following hospitalization.

Group Type EXPERIMENTAL

Problem Solving Education tailored to NICU

Intervention Type BEHAVIORAL

Control

Both study groups receive standard NICU medical, social work, and nursing services. At each study site, attending neonatologists and pediatrics residents constitute the medical team, and all families are assigned a social worker.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Problem Solving Education tailored to NICU

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes