Supporting At-Risk Mothers Across Perinatal Period: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Postnatal depression
研究概览
简要总结
The SMART app is a mobile application based psychosocial parenting intervention containing educational materials (articles, videos, audios, podcasts) on parenting, an integrated peer support chat function with experienced mothers and an integrated forum for interaction with other mother participants.
The goal of this interventional study is to test the effectiveness of a mobile-app health based intervention, SMART, mothers in the perinatal period.
The main questions this study aims to answer are:
- What is the effect of a mobile-based health intervention, SMART, on maternal outcomes?
- What is the effect of a mobile-based health intervention, SMART, on infant outcomes?
- What is the cost-effectiveness of using SMART as compared to standard routine care?
Researchers will compare results with a control group that will undergo standard routine care.
详细描述
This project aims to develop and evaluate a mobile-health application based Supporting at-risk Mothers across perinatal period: A Randomized controlled Trial (SMART) intervention on maternal outcomes such as maternal depression, anxiety and stress, parenting self-efficacy, help-seeking behaviour and attachment and interaction levels , newborn outcomes such as physical, social and emotional development as well as the cost-effectiveness of the intervention.
When compared with those in the control group receiving standard care:
- mothers receiving SMART intervention will have better: i) emotional well-being (reduced depression, stress, and anxiety); ii) parenting self-efficacy; iii) social support; and iv) attachment, interactions with their newborns and parenting satisfaction.
- newborns of mothers receiving SMART will have better: i) physical development; ii) social development; and iii) emotional development.
- It will be more cost-effective to provide SMART than the standard care.
A randomized controlled, two-group pre-test and repeated post-tests, experimental design will be used. Mothers will be randomly assigned to the intervention group, where they will receive the SMART intervention (Access to the mobile App from pregnancy till 6 months postpartum) which includes knowledge-based content with audio and video materials, a peer discussion forum with other mothers, online chat groups with peer volunteer who are experienced mothers plus the standard care. Peer volunteers will be recruited and their role is to provide support to the mother via a weekly chat with the mothers through the SMART application. The control group will receive the standard care provided by the hospitals and polyclinics. The effectiveness of SMART intervention will be measured based on the improvement of maternal depression (primary outcome), stress and anxiety, parenting self-efficacy in newborn care, social support received by mothers, mother-infant attachment, and interactions as well as newborn outcomes including physical, behavioral (social) and emotional development.
Newborn data such as baby gender, order of birth, baby weight and developmental milestones will be collected to examine their development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •mothers who (1) are 21 years old to 65 years old; (2) can read and speak English; (3) belong to a vulnerable population due to one or more of the following criteria: i) monthly household income is =/less than SGD 2500 and/or under any low-income support services (referral from social workers) ii) have positive maternal Adverse Childhood Events (ACES) evaluation; iii) single mother; iv) clinically referred by medical professionals or other allied workers for requiring psychosocial support; v) pregnancy or birth of baby diagnosed with congenital malformation/abnormality where baby is 1 year old or less and can be discharged home with mother; vi) mothers with Edinburgh Postnatal Depression Scores (EPDS) =9 (at-risk for depression); and (4) have a smartphone with internet access.
排除标准
- •mothers who (1) have chronic physical or mental disorders which would interfere with their ability to participate in the study, and/or (2) gave birth to a baby who needs prolonged hospitalization or NICU support and /or stillborn (3) has a cognitive impairment
结局指标
主要结局
Postnatal depression
时间窗: Baseline and 6 month, 9month, 12month post childbirth
Measured via the Edinburgh Postnatal Depression Scale, a 10-item self-reported questionnaire based on a 4-point Likert scale
次要结局
- Infant physical development(1 month and 6 month at immediate post intervention)
- Infant cognitive development(1 month and 6 month at immediate post intervention)
- Perceived stress(Baseline and 6 month, 9month, 12month post childbirth)
- Parental satisfaction(Baseline and 6 month, 9month, 12month post childbirth)
- Parental efficacy(Baseline and 6 month, 9month, 12month post childbirth)
- Objective stress(1 month and 6 month at immediate post intervention)
- Infant Emotional Development(12 month post childbirth)
- Infant emotional development(1 month and 6 month at immediate post intervention)
- Anxiety(Baseline and 6 month, 9month, 12month post childbirth)
- Perceived social support(Baseline and 6 month, 9month, 12month post childbirth)
- Maternal-infant bonding(1 month, 6 month, 9 month and 12 month post childbirth)
- Infant Physical Development(1 month, 6 month, 9 month and 12 month post childbirth)
- Emotional availability(1 month and 6 month at immediate post intervention)
- Health services and utilization(Baseline, 1 month, 6 month and 12month post childbirth)
- Infant Social Development(1 month and 6 month at immediate post intervention)
研究者
Shefaly Shorey
Associate Professor
National University of Singapore