Perinatal DepressionPDANCT05463926

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

A study testing PDA mobile application in people with Perinatal Depression and Parents, run by National University of Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Perinatal Depression, Parents, Self Efficacy
What is being tested?: PDA mobile application
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 236 participants
Where: 1 siteSingapore
Study dates: 15 Nov 2022to 31 Aug 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

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

Other trials in Singapore

About this study

Official title: 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:

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).

Conditions: Perinatal Depression, Parents, Self Efficacy, Anxiety, Stress, Parenting Satisfaction
Being tested: PDA mobile application
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PDA mobile applicationBehavioural
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.

Study groups in NCT05463926
Study group	Role	What they receive
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 Receives: Behavioral: PDA mobile application
Standard hospital care with follow-up	No intervention	Receive standard hospital care with follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 3 months postpartum

Secondary outcomes (12)

Stress
10-item Perceived Stress Scale (PSS): Score ranges from 0-40, with higher scores indicating higher stress levels
Measured: 1 month postpartum
Stress
10-item Perceived Stress Scale (PSS): Score ranges from 0-40, with higher scores indicating higher stress levels
Measured: 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
Measured: 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
Measured: 3 months postpartum
Anxiety
40-item State-Trait Anxiety Inventory (STAI): Score ranges from 40-160, with higher scores indicating more severe anxiety symptoms
Measured: 1 month postpartum
Anxiety
40-item State-Trait Anxiety Inventory (STAI): Score ranges from 40-160, with higher scores indicating more severe anxiety symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 202231 Aug 2023

First posted19 Jul 2022
Study start15 Nov 2022
Primary completion31 Aug 2023
Study completion31 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Perinatal DepressionStudies of the same condition, open and under way.
More trials run by National University of SingaporeThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two-group parallel-armed randomized controlled trial (RCT) with a pretest and repeated posttest experimental design
Masking: None (open label)
Enrolment: 236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05463926
Sponsor's protocol ID: NHG DSRB 2021/00227
Acronym: PDA
Status last verified: Feb 2024
First submitted: 14 Jul 2022
Last updated: 8 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chua JYX, Choolani M, Chee CYI, Yi H, Lalor JG, Chong YS, Shorey S. A Mobile App-Based Intervention (Parentbot-a Digital Healthcare Assistant) for Parents: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2025 Apr 17;27:e64882. doi: 10.2196/64882.
PubMed 40245395
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.
PubMed 39305680

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents
Anxiety, Depression
Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
Recruiting
Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications

All Perinatal Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05463926
Acronym / sponsor ID: PDA / NHG DSRB 2021/00227
Conditions: Perinatal Depression, Parents, Self Efficacy, Anxiety, Stress, Parenting Satisfaction
Study type: Interventional
Recruitment status: Completed
Enrolment: 236 participants (actual)
Lead sponsor: National University of SingaporeUniversity, hospital or other
Study start: 15 Nov 2022 (actual)
Primary completion: 31 Aug 2023 (actual)
Study completion: 31 Aug 2023 (actual)
First posted: 19 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Two-group parallel-armed randomized controlled trial (RCT) with a pretest and repeated posttest experimental design

Arm	Type	Receives
Standard hospital care with follow-up + PDA mobile application	Experimental	Behavioral: PDA mobile applicationReceive standard hospital care and follow-up, and access to the Parentbot - a Digital healthcare Assistant (PDA) mobile application from pregnancy until one-month postpartum
Standard hospital care with follow-up	No intervention	–Receive standard hospital care with follow-up

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PDA mobile applicationParentbot - 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.	Behavioural	Standard hospital care with follow-up + PDA mobile application

Primary outcome

Parenting self-efficacy
Time frame: 1 month postpartum
10-item Parenting Efficacy Scale (PES): Score ranges from 10-40, with higher scores indicating a higher level of perceived parenting self-efficacy
Parenting self-efficacy
Time frame: 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

12 secondary outcomes

Stress
Time frame: 1 month postpartum
Stress
Time frame: 3 months postpartum
Depression
Time frame: 1 month postpartum
Depression
Time frame: 3 months postpartum
Anxiety
Time frame: 1 month postpartum
Anxiety
Time frame: 3 months postpartum
Social support
Time frame: 1 month postpartum
Social support
Time frame: 3 months postpartum
Parent-child bonding
Time frame: 1 month postpartum
Parent-child bonding
Time frame: 3 months postpartum
Parenting satisfaction
Time frame: 1 month postpartum
Parenting satisfaction
Time frame: 3 months postpartum

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
Derived from this study: PubMed 40245395Chua JYX, Choolani M, Chee CYI, Yi H, Lalor JG, Chong YS, Shorey S. A Mobile App-Based Intervention (Parentbot-a Digital Healthcare Assistant) for Parents: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2025 Apr 17;27:e64882. doi: 10.2196/64882.
Derived from this study: PubMed 39305680Chua 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.
Individual participant dataSharing planned: No

Related trials for Perinatal Depression

Recruiting
Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents
Anxiety, Depression
Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
Recruiting
Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shefaly Shorey, PhD principal investigator

National University of Singapore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PDA mobile application in people with Perinatal Depression and Parents, run by National University of Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parenting self-efficacy (time frame: 1 month postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05463926, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.