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OpenTrials
Completed

NCT Number: NCT05463926

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

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).

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Key information

Conditions

Perinatal Depression Anxiety Anxiety Disorders Mental Disorders Parenting Satisfaction Parents Self Efficacy Stress

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alice Lee Centre for Nursing Studies, National University of Singapore

Singapore, 117597

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PDA mobile application

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Stress

    Time frame: 1 month postpartum

    10-item Perceived Stress Scale (PSS): Score ranges from 0-40, with higher scores indicating higher stress levels

  2. Stress

    Time frame: 3 months postpartum

    10-item Perceived Stress Scale (PSS): Score ranges from 0-40, with higher scores indicating higher stress levels

  3. Depression

    Time frame: 1 month postpartum

    10-item Edinburgh Postnatal Depression Scale (EPDS) Scale: Score ranges from 0-30, with higher scores indicating more severe depressive symptoms

  4. Depression

    Time frame: 3 months postpartum

    10-item Edinburgh Postnatal Depression Scale (EPDS) Scale: Score ranges from 0-30, with higher scores indicating more severe depressive symptoms

  5. Anxiety

    Time frame: 1 month postpartum

    40-item State-Trait Anxiety Inventory (STAI): Score ranges from 40-160, with higher scores indicating more severe anxiety symptoms

  6. Anxiety

    Time frame: 3 months postpartum

    40-item State-Trait Anxiety Inventory (STAI): Score ranges from 40-160, with higher scores indicating more severe anxiety symptoms

  7. Social support

    Time frame: 1 month postpartum

    4-item Perceived Social Support for Parenting scale (PSSP): Score ranges from 0-16, with higher scores indicating higher level of perceived social support

  8. Social support

    Time frame: 3 months postpartum

    4-item Perceived Social Support for Parenting scale (PSSP): Score ranges from 0-16, with higher scores indicating higher level of perceived social support

  9. Parent-child bonding

    Time frame: 1 month postpartum

    8-item Parent-Infant Bonding Questionnaire (PIBQ): Score ranges from 0-24, with higher scores indicating poorer parent-child bonding

  10. Parent-child bonding

    Time frame: 3 months postpartum

    8-item Parent-Infant Bonding Questionnaire (PIBQ): Score ranges from 0-24, with higher scores indicating poorer parent-child bonding

  11. Parenting satisfaction

    Time frame: 1 month postpartum

    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

  12. Parenting satisfaction

    Time frame: 3 months postpartum

    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

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Official study 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

Acronym: PDA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2022
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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