Effectiveness of 'Supportive Parenting App' on Parental and Newborn Outcomes
2022年4月4日 更新者：Shefaly Shorey、National University of Singapore
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
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
研究概览
研究类型
介入性
注册 (实际的)
398
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Singapore、新加坡、117597
- Alice Lee Centre for Nursing Studies
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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
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The Supportive Parenting Application is a theory-based perinatal educational intervention for couples administered through a mobile application.
The mobile app consist of knowledge-based content, informational videos and audio, discussion forum, chat groups with peer volunteers, and an experts advice section
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无干预：Standard hospital care with follow up
Receive standard hospital care with follow up
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Maternal postpartum depression
大体时间：1 month postpartum
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Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
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1 month postpartum
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Maternal postpartum depression
大体时间：2 month postpartum
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Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
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2 month postpartum
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Maternal postpartum depression
大体时间：4 months postpartum
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Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
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4 months postpartum
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Maternal postpartum depression
大体时间：6 months postpartum
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Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
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6 months postpartum
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Maternal postpartum depression
大体时间：9 months postpartum
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Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
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9 months postpartum
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Maternal postpartum depression
大体时间：12 months postpartum
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Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
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12 months postpartum
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Infant physical, social, and emotional development
大体时间：6 months postpartum
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Bayley-IV scale Minimum raw score of 0 and maximum score of 258 for 129 items.
Higher score indicate better outcome
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6 months postpartum
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Infant physical, social, and emotional development
大体时间：12 months postpartum
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Bayley-IV scale Minimum score of 0 and maximum score of 258 for 129 items.
Higher score indicate better outcome
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12 months postpartum
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Infant physical, social, and emotional development
大体时间：2 months postpartum
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Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes
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2 months postpartum
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Infant physical, social, and emotional development
大体时间：4 months postpartum
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Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes
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4 months postpartum
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Infant physical, social, and emotional development
大体时间：6 months postpartum
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Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes
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6 months postpartum
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Infant physical, social, and emotional development
大体时间：9 months postpartum
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Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes
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9 months postpartum
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Infant physical, social, and emotional development
大体时间：12 months postpartum
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Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes
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12 months postpartum
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Paternal depression
大体时间：1 month postpartum
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Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
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1 month postpartum
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Paternal depression
大体时间：2 month postpartum
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Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
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2 month postpartum
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Paternal depression
大体时间：4 month postpartum
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Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
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4 month postpartum
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Paternal depression
大体时间：6 month postpartum
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Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
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6 month postpartum
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Paternal depression
大体时间：9 month postpartum
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Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
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9 month postpartum
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Paternal depression
大体时间：12 month postpartum
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Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
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12 month postpartum
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Parental Anxiety
大体时间：1 month postpartum
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State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
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1 month postpartum
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Parental Anxiety
大体时间：2 month postpartum
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State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
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2 month postpartum
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Parental Anxiety
大体时间：4 month postpartum
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State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
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4 month postpartum
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Parental Anxiety
大体时间：6 month postpartum
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State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
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6 month postpartum
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Parental Anxiety
大体时间：9 month postpartum
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State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
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9 month postpartum
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Parental Anxiety
大体时间：12 month postpartum
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State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
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12 month postpartum
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Parenting self-efficacy
大体时间：1 month postpartum
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Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
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1 month postpartum
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Parenting self-efficacy
大体时间：2 month postpartum
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Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
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2 month postpartum
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Parenting self-efficacy
大体时间：4 month postpartum
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Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
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4 month postpartum
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Parenting self-efficacy
大体时间：6 month postpartum
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Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
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6 month postpartum
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Parenting self-efficacy
大体时间：9 month postpartum
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Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
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9 month postpartum
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Parenting self-efficacy
大体时间：12 month postpartum
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Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
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12 month postpartum
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Perceived social support
大体时间：1 month postpartum
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Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40.
Higher score indicate higher perceived support.
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1 month postpartum
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Perceived social support
大体时间：2 month postpartum
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Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40.
Higher score indicate higher perceived support.
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2 month postpartum
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Perceived social support
大体时间：4 month postpartum
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Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40.
Higher score indicate higher perceived support.
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4 month postpartum
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Perceived social support
大体时间：6 month postpartum
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Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40.
Higher score indicate higher perceived support.
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6 month postpartum
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Perceived social support
大体时间：9 month postpartum
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Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40.
Higher score indicate higher perceived support.
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9 month postpartum
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Perceived social support
大体时间：12 month postpartum
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Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40.
Higher score indicate higher perceived support.
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12 month postpartum
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Parent-Infant bonding
大体时间：1 month postpartum
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Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
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1 month postpartum
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Parent-Infant bonding
大体时间：2 month postpartum
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Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
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2 month postpartum
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Parent-Infant bonding
大体时间：4 month postpartum
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Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
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4 month postpartum
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Parent-Infant bonding
大体时间：6 month postpartum
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Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
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6 month postpartum
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Parent-Infant bonding
大体时间：9 month postpartum
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Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
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9 month postpartum
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Parent-Infant bonding
大体时间：12 month postpartum
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Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
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12 month postpartum
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Parenting satisfaction
大体时间：1 month postpartum
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What Being the Parent of a New Baby is Like Questionnaire (WPBL) 11-items, scores range from 0 to 99 with higher scores indicating better parenting satisfaction.
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1 month postpartum
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Parenting satisfaction
大体时间：2 month postpartum
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What Being the Parent of a New Baby is Like Questionnaire (WPBL) 11-items, scores range from 0 to 99 with higher scores indicating better parenting satisfaction.
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2 month postpartum
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Parenting satisfaction
大体时间：4 month postpartum
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What Being the Parent of a New Baby is Like Questionnaire (WPBL) 11-items, scores range from 0 to 99 with higher scores indicating better parenting satisfaction.
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4 month postpartum
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Parenting satisfaction
大体时间：6 month postpartum
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What Being the Parent of a New Baby is Like Questionnaire (WPBL) 11-items, scores range from 0 to 99 with higher scores indicating better parenting satisfaction.
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6 month postpartum
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Parenting satisfaction
大体时间：9 month postpartum
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What Being the Parent of a New Baby is Like Questionnaire (WPBL) 11-items, scores range from 0 to 99 with higher scores indicating better parenting satisfaction.
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9 month postpartum
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Parenting satisfaction
大体时间：12 month postpartum
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What Being the Parent of a New Baby is Like Questionnaire (WPBL) 11-items, scores range from 0 to 99 with higher scores indicating better parenting satisfaction.
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12 month postpartum
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Shefaly Shorey, PhD、National University of Singapore
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年3月1日
初级完成 (实际的)
2022年3月22日
研究完成 (实际的)
2022年3月22日
研究注册日期
首次提交
2021年1月7日
首先提交符合 QC 标准的
2021年1月10日
首次发布 (实际的)
2021年1月12日
研究记录更新
最后更新发布 (实际的)
2022年4月12日
上次提交的符合 QC 标准的更新
2022年4月4日
最后验证
2022年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Supportive Parenting Application的临床试验
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University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的