Supporting At-Risk Mothers Across Perinatal Period (SMART)

National University of Singapore

Status: Enrolling

Conditions: Perinatal Depression; Self Efficacy; Parents; Infant Development; Anxiety; Stress

Treatments: Behavioral: Supporting at-risk Mothers Across perinatal period: a Randomized controlled Trial (SMART) mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT06363019

2023/00158

Details and patient eligibility

About

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.

Full 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:

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. newborns of mothers receiving SMART will have better: i) physical development; ii) social development; and iii) emotional development. 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• mothers who (1) are 21 years old to 65 years old; (2) can read and speak English; (3) belong to a vulnerable population due to one or more of the following criteria: i) monthly household income is =/less than SGD 2500 and/or under any low-income support services (referral from social workers) ii) have positive maternal Adverse Childhood Events (ACES) evaluation; iii) single mother; iv) clinically referred by medical professionals or other allied workers for requiring psychosocial support; v) pregnancy or birth of baby diagnosed with congenital malformation/abnormality where baby is 1 year old or less and can be discharged home with mother; vi) mothers with Edinburgh Postnatal Depression Scores (EPDS) =9 (at-risk for depression); and (4) have a smartphone with internet access.

Exclusion criteria

• mothers who (1) have chronic physical or mental disorders which would interfere with their ability to participate in the study, and/or (2) gave birth to a baby who needs prolonged hospitalization or NICU support and /or stillborn (3) has a cognitive impairment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Mothers using SMART app

Experimental group

Description:

The intervention will be delivered via a mobile-based application, the SMART app. The intervention consists of educational material on parenting, pregnancy and managing emotional well-being that mothers are to engage in. Mothers will also participate in the forum with other mother participants. Mothers will also engage in the chat function with a peer volunteer who is an experienced mother. The app is accessible to the mother via the Android or iOS playstore and mother can access anytime in their convenience over 6 months.

Treatment:

Behavioral: Supporting at-risk Mothers Across perinatal period: a Randomized controlled Trial (SMART) mobile application

Standard Care

No Intervention group

Description:

This includes routine perinatal visits and check-ups at the hospital or polyclinic the mother is assigned to.