Evaluate the Effectiveness and Cost-effectiveness of 'Supportive Parenting App' a Mobile Based Application on Parental and Newborn Outcomes: A Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- Maternal postpartum depression
研究概览
简要总结
The Supportive Parenting App is a theory-based perinatal educational intervention for couples administered through a mobile application. The intervention comprise of knowledge-based content, informational videos and audio, discussion forum, peer volunteer chat group, and a frequently asked questions (FAQ) expert advice section.
The aims of the study are to:
- develop theory-based supportive parenting App (SPA) intervention for both first-time and experienced parents across perinatal period
- examine its effectiveness on parental outcomes: including maternal depression at 12 months postpartum (primary outcome), paternal depression, parental anxiety, parenting self-efficacy, help - seeking behavior (social support), parental bonding and parenting satisfaction (secondary outcomes); and new-born outcomes: physical, social and emotional developments (secondary outcomes)
- evaluate SPA's cost-effectiveness as compared to standard perinatal care across major restructured hospitals, and
- examine the perceptions of parents in receiving this intervention.
When compared with those in the control group receiving standard care:
- parents receiving SPA intervention will have better- emotional well-being (reduced depression and anxiety);parenting self-efficacy; social support; bonding and satisfaction.
- new-borns of parents receiving SPA will have better physical, social and emotional development
- It will be more cost-effective to provide SPA than the standard care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able to read and speak English
- •have low-risk singleton pregnancy with more than 24 weeks of gestation (age of viability)
- •have smartphone with internet access
排除标准
- •have physical or mental disorders which would interfere with their ability to participate in the study
- •have high-risk pregnancy including placenta-previa major, pre-eclampsia, pregnancy induced hypertension etc.
- •have complicated assisted delivery such as vacuum or forceps with 4th degree perineal tear of the mother; and /or
- •give birth to a newborn at still-birth or a newborn with congenital anomalies and/or medical complications including pathological jaundice, that required special care in hospital.
研究组 & 干预措施
Standard hospital care with follow up
Receive standard hospital care with follow up
Standard hospital care with follow up + Supportive Parenting App
Receive standard hospital care and follow up, and access to the Supportive Parenting App from pregnancy to 6 months postpartum
干预措施: Supportive Parenting Application (Other)
结局指标
主要结局
Maternal postpartum depression
时间窗: 12 months postpartum
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Maternal postpartum depression
时间窗: 1 month postpartum
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Maternal postpartum depression
时间窗: 2 month postpartum
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Maternal postpartum depression
时间窗: 4 months postpartum
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Maternal postpartum depression
时间窗: 6 months postpartum
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Maternal postpartum depression
时间窗: 9 months postpartum
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
次要结局
- Infant physical, social, and emotional development(12 months postpartum)
- Paternal depression(12 month postpartum)
- Parental Anxiety(12 month postpartum)
- Parenting self-efficacy(12 month postpartum)
- Perceived social support(12 month postpartum)
- Parent-Infant bonding(12 month postpartum)
- Parenting satisfaction(12 month postpartum)
- Infant physical, social, and emotional development(6 months postpartum)
- Infant physical, social, and emotional development(2 months postpartum)
- Infant physical, social, and emotional development(4 months postpartum)
- Infant physical, social, and emotional development(9 months postpartum)
- Paternal depression(1 month postpartum)
- Paternal depression(2 month postpartum)
- Paternal depression(4 month postpartum)
- Paternal depression(6 month postpartum)
- Paternal depression(9 month postpartum)
- Parental Anxiety(1 month postpartum)
- Parental Anxiety(2 month postpartum)
- Parental Anxiety(4 month postpartum)
- Parental Anxiety(6 month postpartum)
- Parental Anxiety(9 month postpartum)
- Parenting self-efficacy(1 month postpartum)
- Parenting self-efficacy(2 month postpartum)
- Parenting self-efficacy(4 month postpartum)
- Parenting self-efficacy(6 month postpartum)
- Parenting self-efficacy(9 month postpartum)
- Perceived social support(1 month postpartum)
- Perceived social support(2 month postpartum)
- Perceived social support(4 month postpartum)
- Perceived social support(6 month postpartum)
- Perceived social support(9 month postpartum)
- Parent-Infant bonding(1 month postpartum)
- Parent-Infant bonding(2 month postpartum)
- Parent-Infant bonding(4 month postpartum)
- Parent-Infant bonding(6 month postpartum)
- Parent-Infant bonding(9 month postpartum)
- Parenting satisfaction(1 month postpartum)
- Parenting satisfaction(2 month postpartum)
- Parenting satisfaction(4 month postpartum)
- Parenting satisfaction(6 month postpartum)
- Parenting satisfaction(9 month postpartum)
研究者
Shefaly Shorey
Assistant Professor
National University of Singapore