Clinical trial NCT05463926: Effect of 'Parentbot - a Digital Healthcare Assistant (PDA)' in Improving Parenting Outcomes During the Perinatal Period
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
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Parents
Self Efficacy
Anxiety
Stress
Parenting Satisfaction
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 236
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group parallel-armed randomized controlled trial (RCT) with a pretest and repeated posttest experimental design
Primary purpose: SUPPORTIVE_CARE

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).


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.

Primary outcomes:
measure: Parenting self-efficacy
timeFrame: 1 month postpartum
measure: Parenting self-efficacy
timeFrame: 3 months postpartum
Secondary outcomes:
measure: Stress
timeFrame: 1 month postpartum
measure: Stress
timeFrame: 3 months postpartum
measure: Depression
timeFrame: 1 month postpartum
measure: Depression
timeFrame: 3 months postpartum
measure: Anxiety
timeFrame: 1 month postpartum
measure: Anxiety
timeFrame: 3 months postpartum
measure: Social support
timeFrame: 1 month postpartum
measure: Social support
timeFrame: 3 months postpartum
measure: Parent-child bonding
timeFrame: 1 month postpartum
measure: Parent-child bonding
timeFrame: 3 months postpartum
measure: Parenting satisfaction
timeFrame: 1 month postpartum
measure: Parenting satisfaction
timeFrame: 3 months postpartum
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Alice Lee Centre for Nursing Studies, National University of Singapore
Study officials:
affiliation: National University of Singapore
name: Shefaly Shorey, PhD
role: PRINCIPAL_INVESTIGATOR
References: