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

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

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).

Study Overview

• Status: Completed
• Conditions: Stress; Anxiety; Parents; Self Efficacy; Perinatal Depression; Parenting Satisfaction
• Intervention / Treatment: Behavioral: PDA mobile application

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117597
    • Alice Lee Centre for Nursing Studies, National University of Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard hospital care with follow-up + PDA mobile application; 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; 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.
No Intervention: Standard hospital care with follow-up; Receive standard hospital care with follow-up

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National University of Singapore
• Investigators: Principal Investigator: Shefaly Shorey, PhD, National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: NHG DSRB 2021/00227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No