NCT05463926

Brief Summary

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. 1.Develop a theory-based perinatal intervention with integrated chatbot features for both first-time and experienced parents
  2. 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. 3.Examine the perceptions of parents from both the intervention and control group after the intervention
  4. 4.Collate suggestions for further improvement from the participants and members of the research team

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

July 14, 2022

Last Update Submit

February 6, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Stress

    1 month postpartum

  • Stress

    3 months postpartum

  • Depression

    1 month postpartum

  • Depression

    3 months postpartum

  • Anxiety

    1 month postpartum

  • +7 more secondary outcomes

Study Arms (2)

Standard hospital care with follow-up + PDA mobile application

EXPERIMENTAL

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

Standard hospital care with follow-up

NO INTERVENTION

Receive standard hospital care with follow-up

Interventions

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 + PDA mobile application

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alice Lee Centre for Nursing Studies, National University of Singapore

Singapore, 117597, Singapore

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Shefaly Shorey, PhD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two-group parallel-armed randomized controlled trial (RCT) with a pretest and repeated posttest experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 14, 2022

First Posted

July 19, 2022

Study Start

November 15, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

February 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations