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

Sponsor
National University, Singapore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05463926
Collaborator
(none)
236
1
2
16
14.8

Study Details

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:
  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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PDA mobile application
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
236 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two-group parallel-armed randomized controlled trial (RCT) with a pretest and repeated posttest experimental designTwo-group parallel-armed randomized controlled trial (RCT) with a pretest and repeated posttest experimental design
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Standard hospital care with follow-up + PDA mobile application

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
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.

No Intervention: Standard hospital care with follow-up

Receive standard hospital care with follow-up

Outcome Measures

Primary Outcome Measures

  1. Parenting self-efficacy [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 [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 Outcome Measures

  1. Stress [1 month postpartum]

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

  2. Stress [3 months postpartum]

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

  3. Depression [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alice Lee Centre for Nursing Studies, National University of Singapore Singapore Singapore 117597

Sponsors and Collaborators

  • National University, Singapore

Investigators

  • Principal Investigator: Shefaly Shorey, PhD, National University, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shefaly Shorey, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier:
NCT05463926
Other Study ID Numbers:
  • NHG DSRB 2021/00227
First Posted:
Jul 19, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022