Supporting At-Risk Mothers Across Perinatal Period
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-65
SponsorNational University of Singapore
About this 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:
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Supporting at-risk Mothers Across perinatal period: a Randomized controlled Trial (SMART) mobile application
BehavioralThe 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Mothers using SMART appExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
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
Time frame
Baseline and 6 month, 9month, 12month post childbirthSecondary outcomes
1
Infant physical development
Measured via the Bayley Scale-4th edition
Time frame
1 month and 6 month at immediate post intervention2
Infant cognitive development
Measured via the Bayley Scale-4th edition
Time frame
1 month and 6 month at immediate post intervention3
Infant emotional development
Measured via the Bayley Scale-4th edition
Time frame
1 month and 6 month at immediate post intervention4
Anxiety
Measured via the State Trait Anxiety Inventory (STAI), a 40-item self-reported questionnaire based on a 4-point Likert scale
Time frame
Baseline and 6 month, 9month, 12month post childbirthSponsors and contacts
Click on the lead sponsor to view all of their trials.
National University of Singapore
Lead sponsor
Ministry of Health, Singapore
Collaborator
Source ClinicalTrials.gov