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

NCT ID: NCT05463926

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-08-31

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:

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).

Detailed Description

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Conditions

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Perinatal Depression Parents Self Efficacy Anxiety Stress Parenting Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-group parallel-armed randomized controlled trial (RCT) with a pretest and repeated posttest experimental design
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

PDA mobile application

Intervention Type BEHAVIORAL

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.

Standard hospital care with follow-up

Receive standard hospital care with follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University of Singapore

OTHER

Sponsor Role lead

Responsible Party

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Shefaly Shorey

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shefaly Shorey, PhD

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore

Locations

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Alice Lee Centre for Nursing Studies, National University of Singapore

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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Chua JYX, Choolani M, Chee CYI, Yi H, Chan YH, Lalor JG, Chong YS, Shorey S. The effectiveness of Parentbot - a digital healthcare assistant - on parenting outcomes: A randomized controlled trial. Int J Nurs Stud. 2024 Dec;160:104906. doi: 10.1016/j.ijnurstu.2024.104906. Epub 2024 Sep 13.

Reference Type DERIVED
PMID: 39305680 (View on PubMed)

Other Identifiers

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NHG DSRB 2021/00227

Identifier Type: -

Identifier Source: org_study_id

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