Supporting At-Risk Mothers Across Perinatal Period

NCT06363019 | Recruiting

• 1 other identifier: 2023/00158
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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. 1.What is the effect of a mobile-based health intervention, SMART, on maternal outcomes?
2. 2.What is the effect of a mobile-based health intervention, SMART, on infant outcomes?
3. 3.What is the cost-effectiveness of using SMART as compared to standard routine care?

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Postnatal depression

  Measured via the Edinburgh Postnatal Depression Scale, a 10-item self-reported questionnaire based on a 4-point Likert scale

  Baseline and 6 month, 9month, 12month post childbirth

Secondary Outcomes (17)

• Infant physical development

  1 month and 6 month at immediate post intervention

• Infant cognitive development

  1 month and 6 month at immediate post intervention

• Infant emotional development

  1 month and 6 month at immediate post intervention

• Anxiety

  Baseline and 6 month, 9month, 12month post childbirth

• Perceived stress

  Baseline and 6 month, 9month, 12month post childbirth

Study Arms (2)

Mothers using SMART app

EXPERIMENTAL

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.

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

Standard Care

NO INTERVENTION

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

Interventions

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

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.

Mothers using SMART app

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead
• Ministry of Health, Singapore: collaborator

Study Sites (2)

Alice Lee Centre for Nursing Studies, National University of Singapore

Singapore, 117597, Singapore

RECRUITING

National University of Singapore

Singapore, 117597, Singapore

RECRUITING

Related Publications (1)

• Shah L, Aayisha, Goh YS, Choolani M, Eriksson JG, Chee CYI, Chong SC, Mathews J, Lim LHK, Morelius E, Shorey S. A Window Into Vulnerability and Support: At-Risk Mothers' Perinatal Experiences and Perspectives on mHealth-Based Care. J Adv Nurs. 2025 Oct 18. doi: 10.1111/jan.70292. Online ahead of print.

  PMID: 41109313 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Shefaly Shorey, PhD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shefaly Shorey, PhD

CONTACT

66011294; nurssh@nus.edu.sg

Lubna Shah, MA

CONTACT

65163117; nurlis@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two-group parallel-armed randomized controlled trial with a pretest and repeated post-test experimental design

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: April 12, 2024
• Study Start: February 26, 2024
• Primary Completion: February 26, 2025
• Study Completion (Estimated): July 6, 2026
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

SG (2)