Improving Preterm Outcomes by Safeguarding Maternal Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 8
- 主要终点
- Incidence of major depressive episode and depressive symptom trajectories
研究概览
简要总结
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.
详细描述
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.
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Primary aims. Regarding outcomes for mothers, the investigators aim to:
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Decrease the incidence of major depressive episode (MDE) and improve depressive symptom trajectories during the first postpartum year; and
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Improve general and parental functioning, as measured by valid and reliable scales.
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Secondary aims. Regarding risk mechanisms and child outcomes, the investigators aim to:
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Improve mothers' sense of mastery, and decrease their caregiver burden and social isolation;
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Improve adherence to evidence-based quality indicators for NICU follow-up care;
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Improve maternal sensitivity and mother-child interaction patterns; and
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Improve infant social engagement, emotionality, and cognitive functioning.
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Exploratory aims. the investigators will explore the role of a brief set of potential intervention moderators:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Problem Solving Education tailored to NICU (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.
结局指标
主要结局
Incidence of major depressive episode and depressive symptom trajectories
时间窗: one year
To measure depression and depressive symptom trajectories, we will combine a dimensional measure (the Quick Inventory of Depressive Symptoms - QIDS) with the diagnostic Structured Clinical Interview for DSM-IV Disorders (SCID). Administering the QIDS every other month during this time frame will allow us to follow depression symptom trajectories with a repeated measure sensitive to change with treatment. Administering the SCID at 12-months will allow us to determine timing and severity of major depressive episode(s).
General Functioning
时间窗: one year
General functioning will be measured by the mean total SAS-SR score, and mean scores for the family, partner, and social SAS subscales. The SAS will be administered at 6 and 12 months of follow-up.
次要结局
- Socio-emotional functioning(one year)
- Cognitive functioning(one year)
- Caregiver burden, mastery and social support(one year)
- Adherence to recommended NICU follow-up care(one year)
- Parent-child interaction(one year)