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临床试验/NCT05463926
NCT05463926已完成不适用

Effectiveness of 'Parentbot - a Digital Healthcare Assistant (PDA)', a Mobile Application-based Intervention, in Improving Parental Psychosocial Outcomes During the Perinatal Period: a Randomized Controlled Trial and Process Evaluation

National University of Singapore2 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2022年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
236
试验地点
2
主要终点
Parenting self-efficacy

研究概览

简要总结

The Parentbot - a Digital healthcare Assistant (PDA) is a mobile application-based psychosocial parenting intervention with integrated chatbot features, intended for couples to use during the perinatal period. It provides parents with multimedia educational materials (text files, audio files and videos), discussion forum, guided mindfulness-based meditation videos, guided reflection and gratitude journals and a chatbot to answer their queries related to perinatal care in real-time.

This study aims to:

  1. Develop a theory-based perinatal intervention with integrated chatbot features for both first-time and experienced parents
  2. Examine the effectiveness of the PDA intervention in improving parenting self-efficacy (primary outcome), stress, depression, anxiety, social support, parent-child bonding and parenting satisfaction (secondary outcomes) among parents during the perinatal period
  3. Examine the perceptions of parents from both the intervention and control group after the intervention
  4. Collate suggestions for further improvement from the participants and members of the research team

The hypotheses of this study are:

The PDA intervention group will have significantly higher scores for parenting self-efficacy, social support, parent-child bonding and parenting satisfaction, as well as lower scores for stress, depression and anxiety compared to the control group receiving standard care after the intervention at one-month postpartum (post-test 1) and three-months postpartum (post-test 2).

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
All
接受健康志愿者

入选标准

  • Heterosexual married couples who are first-time parents or experienced parents are included if they:
  • Are at least 21 years old
  • Are fluent in English
  • Own a smartphone with internet access
  • Intend to stay in Singapore until three months postpartum
  • Are having a low-risk singleton or multiple pregnancy at > 24 gestational weeks (age of viability).

排除标准

  • Couples will be excluded if either parent has:
  • Any self-reported psychiatric disorders, visual, auditory, cognitive impairment and/or any major medical condition that can affect their abilities to participate in the trial
  • High-risk pregnancy including placenta previa major, pre-eclampsia, intrauterine growth restriction etc
  • Suffer from a miscarriage or made the decision to abort their child
  • Give birth to still-birth newborn
  • Give birth to a newborn with congenital anomalies or medical complications (require intensive care, severe jaundice, Down's syndrome)
  • Single parents will also be excluded. If either the mother or father declines to participate in the study while their partner agrees, the couple will not be allowed to participate in the study.

结局指标

主要结局

Parenting self-efficacy

时间窗: 3 months postpartum

10-item Parenting Efficacy Scale (PES): Score ranges from 10-40, with higher scores indicating a higher level of perceived parenting self-efficacy

次要结局

  • Anxiety(3 months postpartum)
  • Depression(3 months postpartum)
  • Social support(3 months postpartum)
  • Parent-child bonding(3 months postpartum)
  • Parenting satisfaction(3 months postpartum)
  • Stress(3 months postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shefaly Shorey

Associate Professor

National University of Singapore

研究点 (2)

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