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

Anxiety Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05463926
• Other study ID #: NHG DSRB 2021/00227
• Status: Completed
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2024
• Source: National University of Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Parenting Satisfaction
• Parents
• Perinatal Depression
• Self Efficacy
• Stress

Intervention

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.

Locations

Country	Name	City	State
Singapore	Alice Lee Centre for Nursing Studies, National University of Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University of Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Stress	10-item Perceived Stress Scale (PSS): Score ranges from 0-40, with higher scores indicating higher stress levels	1 month postpartum
Secondary	Stress	10-item Perceived Stress Scale (PSS): Score ranges from 0-40, with higher scores indicating higher stress levels	3 months postpartum
Secondary	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
Secondary	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
Secondary	Anxiety	40-item State-Trait Anxiety Inventory (STAI): Score ranges from 40-160, with higher scores indicating more severe anxiety symptoms	1 month postpartum
Secondary	Anxiety	40-item State-Trait Anxiety Inventory (STAI): Score ranges from 40-160, with higher scores indicating more severe anxiety symptoms	3 months postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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