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

Primary Purpose

Perinatal Depression, Parents, Self Efficacy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
PDA mobile application
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Perinatal Depression

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Standard hospital care with follow-up + PDA mobile application

Standard hospital care with follow-up

Arm Description

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

Receive standard hospital care with follow-up

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Stress
10-item Perceived Stress Scale (PSS): Score ranges from 0-40, with higher scores indicating higher stress levels
Stress
10-item Perceived Stress Scale (PSS): Score ranges from 0-40, with higher scores indicating higher stress levels
Depression
10-item Edinburgh Postnatal Depression Scale (EPDS) Scale: Score ranges from 0-30, with higher scores indicating more severe depressive symptoms
Depression
10-item Edinburgh Postnatal Depression Scale (EPDS) Scale: Score ranges from 0-30, with higher scores indicating more severe depressive symptoms
Anxiety
40-item State-Trait Anxiety Inventory (STAI): Score ranges from 40-160, with higher scores indicating more severe anxiety symptoms
Anxiety
40-item State-Trait Anxiety Inventory (STAI): Score ranges from 40-160, with higher scores indicating more severe anxiety symptoms
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
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
Parent-child bonding
8-item Parent-Infant Bonding Questionnaire (PIBQ): Score ranges from 0-24, with higher scores indicating poorer parent-child bonding
Parent-child bonding
8-item Parent-Infant Bonding Questionnaire (PIBQ): Score ranges from 0-24, with higher scores indicating poorer parent-child bonding
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
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

Full Information

First Posted
July 14, 2022
Last Updated
September 27, 2022
Sponsor
National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05463926
Brief Title
Effect of 'Parentbot - a Digital Healthcare Assistant (PDA)' in Improving Parenting Outcomes During the Perinatal Period
Acronym
PDA
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression, Parents, Self Efficacy, Anxiety, Stress, Parenting Satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-group parallel-armed randomized controlled trial (RCT) with a pretest and repeated posttest experimental design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard hospital care with follow-up + PDA mobile application
Arm Type
Experimental
Arm Description
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
Arm Title
Standard hospital care with follow-up
Arm Type
No Intervention
Arm Description
Receive standard hospital care with follow-up
Intervention Type
Behavioral
Intervention Name(s)
PDA mobile application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parenting self-efficacy
Description
10-item Parenting Efficacy Scale (PES): Score ranges from 10-40, with higher scores indicating a higher level of perceived parenting self-efficacy
Time Frame
1 month postpartum
Title
Parenting self-efficacy
Description
10-item Parenting Efficacy Scale (PES): Score ranges from 10-40, with higher scores indicating a higher level of perceived parenting self-efficacy
Time Frame
3 months postpartum
Secondary Outcome Measure Information:
Title
Stress
Description
10-item Perceived Stress Scale (PSS): Score ranges from 0-40, with higher scores indicating higher stress levels
Time Frame
1 month postpartum
Title
Stress
Description
10-item Perceived Stress Scale (PSS): Score ranges from 0-40, with higher scores indicating higher stress levels
Time Frame
3 months postpartum
Title
Depression
Description
10-item Edinburgh Postnatal Depression Scale (EPDS) Scale: Score ranges from 0-30, with higher scores indicating more severe depressive symptoms
Time Frame
1 month postpartum
Title
Depression
Description
10-item Edinburgh Postnatal Depression Scale (EPDS) Scale: Score ranges from 0-30, with higher scores indicating more severe depressive symptoms
Time Frame
3 months postpartum
Title
Anxiety
Description
40-item State-Trait Anxiety Inventory (STAI): Score ranges from 40-160, with higher scores indicating more severe anxiety symptoms
Time Frame
1 month postpartum
Title
Anxiety
Description
40-item State-Trait Anxiety Inventory (STAI): Score ranges from 40-160, with higher scores indicating more severe anxiety symptoms
Time Frame
3 months postpartum
Title
Social support
Description
4-item Perceived Social Support for Parenting scale (PSSP): Score ranges from 0-16, with higher scores indicating higher level of perceived social support
Time Frame
1 month postpartum
Title
Social support
Description
4-item Perceived Social Support for Parenting scale (PSSP): Score ranges from 0-16, with higher scores indicating higher level of perceived social support
Time Frame
3 months postpartum
Title
Parent-child bonding
Description
8-item Parent-Infant Bonding Questionnaire (PIBQ): Score ranges from 0-24, with higher scores indicating poorer parent-child bonding
Time Frame
1 month postpartum
Title
Parent-child bonding
Description
8-item Parent-Infant Bonding Questionnaire (PIBQ): Score ranges from 0-24, with higher scores indicating poorer parent-child bonding
Time Frame
3 months postpartum
Title
Parenting satisfaction
Description
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
Time Frame
1 month postpartum
Title
Parenting satisfaction
Description
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
Time Frame
3 months postpartum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shefaly Shorey, PhD
Phone
66011294
Ext
+ (65)
Email
nurssh@nus.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Joelle YX Chua, BSc (Hons)
Phone
93286164
Ext
+ (65)
Email
e0006986@u.nus.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shefaly Shorey, PhD
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alice Lee Centre for Nursing Studies, National University of Singapore
City
Singapore
ZIP/Postal Code
117597
Country
Singapore
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shefaly Shorey, PhD
Phone
66011294
Ext
+(65)
Email
nurssh@nus.edu.sg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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