Effect of 'Parentbot - a Digital Healthcare Assistant (PDA)' in Improving Parenting Outcomes During the Perinatal Period

Study Overview
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Brief Summary
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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: Develop a theory-based perinatal intervention with integrated chatbot features for both first-time and experienced parents 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 Examine the perceptions of parents from both the intervention and control group after the intervention 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).

Official Title
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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

Conditions
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Parents, Perinatal Depression, Self Efficacy, Anxiety, Stress, Parenting Satisfaction

Intervention / Treatment
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* Behavioral: PDA mobile application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-group parallel-armed randomized controlled trial (RCT) with a pretest and repeated posttest experimental design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard hospital care with follow-up + PDA mobile application<br>Receive standard hospital care and follow-up, and access to the Parentbot - a Digital healthcare Assistant (PDA) mobile application from pregnancy until one-month postpartum | Behavioral: PDA mobile application<br>* Parentbot - a Digital healthcare Assistant (PDA): A mobile application-based psychosocial parenting intervention with integrated chatbot features. It consists of multimedia educational materials (text files, audio files and videos), discussion forums, guided mindfulness-based meditation videos, guided reflection and gratitude journals and a chatbot.<br>|
| No Intervention: Standard hospital care with follow-up<br>Receive standard hospital care with follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting self-efficacy | 10-item Parenting Efficacy Scale (PES): Score ranges from 10-40, with higher scores indicating a higher level of perceived parenting self-efficacy | 1 month postpartum | 
| Parenting self-efficacy | 10-item Parenting Efficacy Scale (PES): Score ranges from 10-40, with higher scores indicating a higher level of perceived parenting self-efficacy | 3 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress | 10-item Perceived Stress Scale (PSS): Score ranges from 0-40, with higher scores indicating higher stress levels | 1 month postpartum | 
| Stress | 10-item Perceived Stress Scale (PSS): Score ranges from 0-40, with higher scores indicating higher stress levels | 3 months postpartum | 
| Depression | 10-item Edinburgh Postnatal Depression Scale (EPDS) Scale: Score ranges from 0-30, with higher scores indicating more severe depressive symptoms | 1 month postpartum | 
| Depression | 10-item Edinburgh Postnatal Depression Scale (EPDS) Scale: Score ranges from 0-30, with higher scores indicating more severe depressive symptoms | 3 months postpartum | 
| Anxiety | 40-item State-Trait Anxiety Inventory (STAI): Score ranges from 40-160, with higher scores indicating more severe anxiety symptoms | 1 month postpartum | 
| Anxiety | 40-item State-Trait Anxiety Inventory (STAI): Score ranges from 40-160, with higher scores indicating more severe anxiety symptoms | 3 months postpartum | 
| Social support | 4-item Perceived Social Support for Parenting scale (PSSP): Score ranges from 0-16, with higher scores indicating higher level of perceived social support | 1 month postpartum | 
| Social support | 4-item Perceived Social Support for Parenting scale (PSSP): Score ranges from 0-16, with higher scores indicating higher level of perceived social support | 3 months postpartum | 
| Parent-child bonding | 8-item Parent-Infant Bonding Questionnaire (PIBQ): Score ranges from 0-24, with higher scores indicating poorer parent-child bonding | 1 month postpartum | 
| Parent-child bonding | 8-item Parent-Infant Bonding Questionnaire (PIBQ): Score ranges from 0-24, with higher scores indicating poorer parent-child bonding | 3 months postpartum | 
| Parenting satisfaction | 11-item evaluation subscale of the What Being the Parent of a Baby is Like scale (WBPL): Score ranges from 0-90, with higher scores indicating greater parenting satisfaction | 1 month postpartum | 
| Parenting satisfaction | 11-item evaluation subscale of the What Being the Parent of a Baby is Like scale (WBPL): Score ranges from 0-90, with higher scores indicating greater parenting satisfaction | 3 months postpartum |