The Northern Babies Longitudinal Study: Predicting Postpartum Depression and Improving Parent-infant Interaction With The Newborn Behavioral Observation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Levels of postpartum depression
研究概览
简要总结
Postpartum depression (PPD) is a prevalent disorder. Studying the factors related to PPD will help to identify families at risk and provide preventive interventions. This can in turn improve the developmental trajectories for the children. Several previous studies have investigated risk factors for PPD. However, few studies have focused on cognitive vulnerability factors. The first aim of the present study is to explore a range of protective and risk factors, including cognitive factors, for PPD, parent-infant interactions and child development. The second aim of the study is to evaluate the effectiveness of The Newborn Behavioral Observation (NBO) as a universal preventive intervention delivered in routine practice. The NBO is a brief relationship-enhancing intervention that may reduce depressive symptomatology in mothers.
详细描述
Aims
The present study has three broad aims:
- Examine key pre- and postnatal predictors related to parental functioning: a) parental depression, anxiety, and stress, b) parental reflective functioning in relation to the infant, and c) parent-infant attachment style.
- Examine key pre- and postnatal predictors related to interaction and developmental problems in the child: a) difficulties in parent-infant interaction in the first 4 months post-delivery, and b) infant's cognitive, communicative and motor development, signs of sustained withdrawal behaviour, and heart-rate variability at 6 months post-delivery.
- Evaluate the effectiveness of the NBO as a universal preventive intervention delivered in routine practice as compared to standard care, on:
- Parental outcomes (depressive symptoms, parenting stress, reflective functioning, attachment to the infant),
- Relational outcomes (emotional availability in parent-child interaction), and
- Infant outcomes (cognitive, communicative and motor development at 6 months post-delivery, heart-rate variability).
Predictor variables include some well-known vulnerability factors for developing PPD (e.g., depression symptoms in pregnancy, adult attachment style, relationship satisfaction and life stress), but the main focus in the observational part of the research project is on cognitive vulnerability factors such as early maladaptive schemas, repetitive negative thinking, rumination, implicit attitudes and cognitive processing of emotionally valenced infant facial information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant woman and expecting fathers
- •Speak Norwegian
排除标准
- •Do not speak Norwegian
研究组 & 干预措施
NBO plus routine care
The Newborn Behavioral Observation
干预措施: The Newborn Behavioral Observation (NBO) (Behavioral)
NBO plus routine care
The Newborn Behavioral Observation
干预措施: Routine care (Behavioral)
Routine care
干预措施: Routine care (Behavioral)
结局指标
主要结局
Levels of postpartum depression
时间窗: Six weeks postpartum
Mothers and fathers self-reported levels of postpartum depression measured with the Edinburgh Postnatal Depression Scale.
次要结局
- Parental reflective functioning(Four months postpartum)
- Bonding between parent and child(Four months postpartum)
- Parental stress(Four months postpartum)
- A composite measure of the infant´s temperament(Six months postpartum)
- Infant cognitive, communicative and motor development(Six months postpartum)
- Levels of postpartum depression(Six months postpartum)
- Parent-child interaction(Four months postpartum)
- Infants social withdrawal behaviour(Six months postpartum)
- Heart rate variability(Six months postpartum)