- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06363019
Supporting At-Risk Mothers Across Perinatal Period (SMART)
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.
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.
Study Overview
Status
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shefaly Shorey, PhD
- Phone Number: 66011294
- Email: nurssh@nus.edu.sg
Study Contact Backup
- Name: Lubna Shah, MA
- Phone Number: 65163117
- Email: nurlis@nus.edu.sg
Study Locations
-
-
-
Singapore, Singapore, 117597
- Recruiting
- National University of Singapore
-
Contact:
- Shefaly Shorey
- Phone Number: +6566011294
- Email: nurssh@nus.edu.sg
-
Singapore, Singapore, 117597
- Recruiting
- Alice Lee Centre for Nursing Studies, National University of Singapore
-
Contact:
- Shefaly Shorey, PhD
- Phone Number: +(65) 66011294
- Email: nurssh@nus.edu.sg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mothers using SMART app
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.
|
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.
|
No Intervention: Standard Care
This includes routine perinatal visits and check-ups at the hospital or polyclinic the mother is assigned to.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline and 6 month, 9month, 12month post childbirth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant physical development
Time Frame: 1 month and 6 month at immediate post intervention
|
Measured via the Bayley Scale-4th edition
|
1 month and 6 month at immediate post intervention
|
Infant cognitive development
Time Frame: 1 month and 6 month at immediate post intervention
|
Measured via the Bayley Scale-4th edition
|
1 month and 6 month at immediate post intervention
|
Infant emotional development
Time Frame: 1 month and 6 month at immediate post intervention
|
Measured via the Bayley Scale-4th edition
|
1 month and 6 month at immediate post intervention
|
Anxiety
Time Frame: Baseline and 6 month, 9month, 12month post childbirth
|
Measured via the State Trait Anxiety Inventory (STAI), a 40-item self-reported questionnaire based on a 4-point Likert scale
|
Baseline and 6 month, 9month, 12month post childbirth
|
Perceived stress
Time Frame: Baseline and 6 month, 9month, 12month post childbirth
|
Measured via the Perceived Stress Scale-10 (PSS-10), a 10-item self-reported questionnaire on a 5 point Likert scale
|
Baseline and 6 month, 9month, 12month post childbirth
|
Perceived social support
Time Frame: Baseline and 6 month, 9month, 12month post childbirth
|
Measured via the Perceived Social Support for Parenting (PSSP), a 10-item questionnaire on a 5-point Liker scale
|
Baseline and 6 month, 9month, 12month post childbirth
|
Maternal-infant bonding
Time Frame: 1 month, 6 month, 9 month and 12 month post childbirth
|
Measured via the Maternal-Infant Bonding Scale (MIBS), an 8-item self-reported questionnaire on a 4-point Likert scale
|
1 month, 6 month, 9 month and 12 month post childbirth
|
Parental satisfaction
Time Frame: Baseline and 6 month, 9month, 12month post childbirth
|
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
|
Baseline and 6 month, 9month, 12month post childbirth
|
Parental efficacy
Time Frame: Baseline and 6 month, 9month, 12month post childbirth
|
Measured via a 10-item questionnaire on a 4-point Likert scale
|
Baseline and 6 month, 9month, 12month post childbirth
|
Objective stress
Time Frame: 1 month and 6 month at immediate post intervention
|
Measured via salivary cortisol biomarkers obtained through saliva samples
|
1 month and 6 month at immediate post intervention
|
Emotional availability
Time Frame: 1 month and 6 month at immediate post intervention
|
Measured through the Emotional Availability Scale (EAS), a 5-dimension framework assessing both the parent and the infant via an observer.
|
1 month and 6 month at immediate post intervention
|
Health services and utilization
Time Frame: Baseline, 1 month, 6 month and 12month post childbirth
|
Measured on the Questionnaire on health services and utilization (QHSU)
|
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
|
Measured by the Ages and Stages Questionnaire-3
|
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
|
Measured by the Ages and Stages Questionnaire-3
|
1 month, 6 month, 9 month, 12 month post childbirth
|
Infant Social Development
Time Frame: 12 month post childbirth
|
Measured by the Brief-Infant and Toddle Social and Emotional Assessment (B-ITSEA)
|
12 month post childbirth
|
Infant Social Development
Time Frame: 1 month and 6 month at immediate post intervention
|
Measured by the Bayley Scale-4th edition
|
1 month and 6 month at immediate post intervention
|
Infant Emotional Development
Time Frame: 12 month post childbirth
|
Measured by the Brief Infant Toddler Social Emotional Assessment (B-ITSEA)
|
12 month post childbirth
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shefaly Shorey, PhD, National University of Singapore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/00158
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
University of Sao PauloCompleted
-
Dana-Farber Cancer InstituteEnrolling by invitationStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
Syracuse VA Medical CenterUS Department of Veterans AffairsCompletedEmotional Stress | Psychological Stress | Life StressUnited States
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
Northumbria UniversityVolac International LtdRecruitingStress | Mood | Physiological StressUnited Kingdom
-
Taichung Veterans General HospitalUnknown