Perinatal DepressionSMARTNCT06363019
Supporting At-Risk Mothers Across Perinatal Period
A study of Perinatal Depression and Parents, run by National University of Singapore at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression, Parents, Anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSingapore
- Study dates
- 26 Feb 2024to 6 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Singapore2 sites, 2 recruiting
- Recruiting
Alice Lee Centre for Nursing Studies, National University of Singapore
Singapore, 117597
Shefaly Shorey, PhD, 66011294 ext. +(65), nurssh@nus.edu.sg
- Recruiting
National University of Singapore
Singapore, 117597
Shefaly Shorey, +6566011294, nurssh@nus.edu.sg
About this study
Official title: Supporting At-Risk Mothers Across Perinatal Period: A Randomized Controlled Trial
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.
Read more
The main questions this study aims to answer are:
- What is the effect of a mobile-based health intervention, SMART, on maternal outcomes?
- What is the effect of a mobile-based health intervention, SMART, on infant outcomes?
- 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.
Read the 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:
- 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.
- Conditions
- Perinatal Depression, Parents, Anxiety, Self Efficacy, Stress, Infant Development
- Being tested
- Supporting at-risk Mothers Across perinatal period: a Randomized controlled Trial (SMART) mobile application
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supporting at-risk Mothers Across perinatal period: a Randomized controlled Trial (SMART) mobile applicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postnatal depression
Measured via the Edinburgh Postnatal Depression Scale, a 10-item self-reported questionnaire based on a 4-point Likert scale
Measured: Baseline and 6 month, 9month, 12month post childbirth
Secondary outcomes (17)
Infant physical development
Measured via the Bayley Scale-4th edition
Measured: 1 month and 6 month at immediate post intervention
Infant cognitive development
Measured via the Bayley Scale-4th edition
Measured: 1 month and 6 month at immediate post intervention
Infant emotional development
Measured via the Bayley Scale-4th edition
Measured: 1 month and 6 month at immediate post intervention
Anxiety
Measured via the State Trait Anxiety Inventory (STAI), a 40-item self-reported questionnaire based on a 4-point Likert scale
Measured: Baseline and 6 month, 9month, 12month post childbirth
Perceived stress
Measured via the Perceived Stress Scale-10 (PSS-10), a 10-item self-reported questionnaire on a 5 point Likert scale
Measured: Baseline and 6 month, 9month, 12month post childbirth
Perceived social support
Measured via the Perceived Social Support for Parenting (PSSP), a 10-item questionnaire on a 5-point Liker scale
Measured: Baseline and 6 month, 9month, 12month post childbirth
Maternal-infant bonding
Measured via the Maternal-Infant Bonding Scale (MIBS), an 8-item self-reported questionnaire on a 4-point Likert scale
Measured: 1 month, 6 month, 9 month and 12 month post childbirth
Parental satisfaction
Measured via the What Being the Parent of A Baby is Like (WPL), an 11-item self-reported questionnaire on a 9-point Likert scale
Measured: Baseline and 6 month, 9month, 12month post childbirth
Parental efficacy
Measured via a 10-item questionnaire on a 4-point Likert scale
Measured: Baseline and 6 month, 9month, 12month post childbirth
Objective stress
Measured via salivary cortisol biomarkers obtained through saliva samples
Measured: 1 month and 6 month at immediate post intervention
Emotional availability
Measured through the Emotional Availability Scale (EAS), a 5-dimension framework assessing both the parent and the infant via an observer.
Measured: 1 month and 6 month at immediate post intervention
Health services and utilization
Measured on the Questionnaire on health services and utilization (QHSU)
Measured: Baseline, 1 month, 6 month and 12month post childbirth
Infant Physical Development
Measured by the Ages and Stages Questionnaire-3
Measured: 1 month, 6 month, 9 month and 12 month post childbirth
Infant Social Development
Measured by the Ages and Stages Questionnaire-3
Measured: 1 month, 6 month, 9 month, 12 month post childbirth
Infant Social Development
Measured by the Brief-Infant and Toddle Social and Emotional Assessment (B-ITSEA)
Measured: 12 month post childbirth
Infant Social Development
Measured by the Bayley Scale-4th edition
Measured: 1 month and 6 month at immediate post intervention
Infant Emotional Development
Measured by the Brief Infant Toddler Social Emotional Assessment (B-ITSEA)
Measured: 12 month post childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start26 Feb 2024
- Primary completion26 Feb 2025 (estimated)
- Study completion6 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group parallel-armed randomized controlled trial with a pretest and repeated post-test experimental design
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Responsible party
- Principal investigator, Shefaly Shorey, National University of Singapore
- Investigators
- Shefaly Shorey, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363019
- Sponsor's protocol ID
- 2023/00158
- Other IDs
- 2023
- Acronym
- SMART
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shah L, Chua JYX, Aayisha A, Goh YS, Choolani M, Eriksson JG, Chee CYI, Chong SC, Mathews J, Lim LHK, Shen L, Morelius E, Shorey S. Supporting at-risk mothers across perinatal period: a randomized controlled trial' (SMART): A development study. Midwifery. 2026 Sep;160:104864. doi: 10.1016/j.midw.2026.104864. Epub 2026 May 20.
PubMed 42208363Shah 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. 2026 Jun;82(6):6557-6572. doi: 10.1111/jan.70292. Epub 2025 Oct 18.
PubMed 41109313
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting At-Risk Mothers Across Perinatal Period: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06363019
- Acronym / sponsor ID
- SMART / 2023/00158
- Conditions
- Perinatal Depression, Parents, Anxiety, Self Efficacy, Stress, Infant Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 26 Feb 2025 (estimated)
- Study completion
- 6 Jul 2026 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the effect of a mobile-based health intervention, SMART, on maternal outcomes?
- What is the effect of a mobile-based health intervention, SMART, on infant outcomes?
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-group parallel-armed randomized controlled trial with a pretest and repeated post-test experimental design
| Arm | Type | Receives |
|---|---|---|
| Mothers using SMART app | Experimental | Behavioral: Supporting at-risk Mothers Across perinatal period: a Randomized controlled Trial (SMART) mobile applicationThe 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. |
| Standard Care | No intervention | –This includes routine perinatal visits and check-ups at the hospital or polyclinic the mother is assigned to. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supporting at-risk Mothers Across perinatal period: a Randomized controlled Trial (SMART) mobile applicationThe 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. | Behavioural | Mothers using SMART app |
Primary outcome
Postnatal depression
Time frame: Baseline and 6 month, 9month, 12month post childbirth
Measured via the Edinburgh Postnatal Depression Scale, a 10-item self-reported questionnaire based on a 4-point Likert scale
17 secondary outcomes
Infant physical development
Time frame: 1 month and 6 month at immediate post intervention
Infant cognitive development
Time frame: 1 month and 6 month at immediate post intervention
Infant emotional development
Time frame: 1 month and 6 month at immediate post intervention
Anxiety
Time frame: Baseline and 6 month, 9month, 12month post childbirth
Perceived stress
Time frame: Baseline and 6 month, 9month, 12month post childbirth
Perceived social support
Time frame: Baseline and 6 month, 9month, 12month post childbirth
Maternal-infant bonding
Time frame: 1 month, 6 month, 9 month and 12 month post childbirth
Parental satisfaction
Time frame: Baseline and 6 month, 9month, 12month post childbirth
Parental efficacy
Time frame: Baseline and 6 month, 9month, 12month post childbirth
Objective stress
Time frame: 1 month and 6 month at immediate post intervention
Emotional availability
Time frame: 1 month and 6 month at immediate post intervention
Health services and utilization
Time frame: Baseline, 1 month, 6 month and 12month post childbirth
Infant Physical Development
Time frame: 1 month, 6 month, 9 month and 12 month post childbirth
Infant Social Development
Time frame: 1 month, 6 month, 9 month, 12 month post childbirth
Infant Social Development
Time frame: 12 month post childbirth
Infant Social Development
Time frame: 1 month and 6 month at immediate post intervention
Infant Emotional Development
Time frame: 12 month post childbirth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Derived from this study: PubMed 42208363Shah L, Chua JYX, Aayisha A, Goh YS, Choolani M, Eriksson JG, Chee CYI, Chong SC, Mathews J, Lim LHK, Shen L, Morelius E, Shorey S. Supporting at-risk mothers across perinatal period: a randomized controlled trial' (SMART): A development study. Midwifery. 2026 Sep;160:104864. doi: 10.1016/j.midw.2026.104864. Epub 2026 May 20.
- Derived from this study: PubMed 41109313Shah 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. 2026 Jun;82(6):6557-6572. doi: 10.1111/jan.70292. Epub 2025 Oct 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shefaly Shorey, PhD principal investigator
National University of Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Perinatal Depression and Parents, run by National University of Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shefaly Shorey, PhD (66011294, nurssh@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postnatal depression (time frame: Baseline and 6 month, 9month, 12month post childbirth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06363019, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.