NCT06363019

Supporting At-Risk Mothers Across Perinatal Period

Supporting At-Risk Mothers Across Perinatal Period: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: National University of Singapore · Academic / Other
• Sex: Female
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The SMART app is a mobile application based psychosocial parenting intervention containing educational materials (articles, videos, audios, podcasts) on parenting, an integrated peer support chat function with experienced mothers and an integrated forum for interaction with other mother participants. The goal of this interventional study is to test the effectiveness of a mobile-app health based intervention, SMART, mothers in the perinatal period. The main questions this study aims to answer are: 1. What is the effect of a mobile-based health intervention, SMART, on maternal outcomes? 2. What is the effect of a mobile-based health intervention, SMART, on infant outcomes? 3. What is the cost-effectiveness of using SMART as compared to standard routine care? Researchers will compare results with a control group that will undergo standard routine care.

Detailed description

This project aims to develop and evaluate a mobile-health application based Supporting at-risk Mothers across perinatal period: A Randomized controlled Trial (SMART) intervention on maternal outcomes such as maternal depression, anxiety and stress, parenting self-efficacy, help-seeking behaviour and attachment and interaction levels , newborn outcomes such as physical, social and emotional development as well as the cost-effectiveness of the intervention. When compared with those in the control group receiving standard care: 1. mothers receiving SMART intervention will have better: i) emotional well-being (reduced depression, stress, and anxiety); ii) parenting self-efficacy; iii) social support; and iv) attachment, interactions with their newborns and parenting satisfaction. 2. newborns of mothers receiving SMART will have better: i) physical development; ii) social development; and iii) emotional development. 3. It will be more cost-effective to provide SMART than the standard care. A randomized controlled, two-group pre-test and repeated post-tests, experimental design will be used. Mothers will be randomly assigned to the intervention group, where they will receive the SMART intervention (Access to the mobile App from pregnancy till 6 months postpartum) which includes knowledge-based content with audio and video materials, a peer discussion forum with other mothers, online chat groups with peer volunteer who are experienced mothers plus the standard care. Peer volunteers will be recruited and their role is to provide support to the mother via a weekly chat with the mothers through the SMART application. The control group will receive the standard care provided by the hospitals and polyclinics. The effectiveness of SMART intervention will be measured based on the improvement of maternal depression (primary outcome), stress and anxiety, parenting self-efficacy in newborn care, social support received by mothers, mother-infant attachment, and interactions as well as newborn outcomes including physical, behavioral (social) and emotional development. Newborn data such as baby gender, order of birth, baby weight and developmental milestones will be collected to examine their development.

Conditions

• Perinatal Depression
• Parents
• Anxiety
• Self Efficacy
• Stress
• Infant Development

Interventions

Type	Name	Description
BEHAVIORAL	Supporting at-risk Mothers Across perinatal period: a Randomized controlled Trial (SMART) mobile application	The intervention is delivered through the SMART mobile application. It contains educational information in audio, visual, article format; on parenting, pregnancy and managing emotional well-being. There is also a peer support feature where participants can speak to experienced mothers via the SMART app. There is also a forum feature where participants can interact with other mothers.

Timeline

• Start date: 2024-02-26
• Primary completion: 2025-02-26
• Completion: 2026-07-06
• First posted: 2024-04-12
• Last updated: 2024-04-12

Locations

2 sites across 1 country: Singapore