Plain English Summary
Background and study aims
The time just after a baby is born (post-natal period) can be a stressful time for new parents. Studies have shown that many first-time mothers and fathers can greatly benefit from coaching and education in the post-natal period as it can help them to become happier and more confident when looking after their baby. Mobile phone apps have been used more and more in healthcare in recent years. This study is looking at a parenting app called “Home-but not alone” which aims to help new parents when the go home from hospital. The aim of this study is to find out whether this app is an effective way of improving parental self-efficacy (independence) and satisfaction, while reducing levels of post-natal depression (low mood after having a baby)
Who can participate?
New parents (mothers and fathers) aged 21 and over who have a healthy baby who will be going home from hospital with them.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group continue to receive usual care during the four weeks of the study, which involves care in hospital after the birth and follow up appointments with their doctor. Those in the second groups receive usual care but also are given access to the “Home-but not alone” app. Both mothers and fathers are actively encouraged to use the app as much as possible and to interact with other users. The app itself involves ongoing communication with a midwife (including exchanging messages and photos), information materials about how best to cope with being a new parent (improving self-efficiency, lowering levels of depression and anxiety), and the automatic sending of push notifications for the first 10 days in order to provide parents with information relating to common questions about breastfeeding and the baby’s health. At the start of the study and again after four weeks, participants in both groups are contacted by telephone to answer questionnaires in order to assess their self-efficiency, satisfaction and mood.
What are the possible benefits and risks of participating?
Participants may benefit from learning new skills which can help them to enhance their parenting self-efficacy, satisfaction and improve their social support network. These parents may also feel better emotionally and be less likely to suffer from post-natal depression. There are no notable risks involved with taking part in this study.
Where is the study run from?
National University Hospital (Singapore)
When is the study starting and how long is it expected to run for?
December 2015 to August 2017
Who is funding the study?
National University of Singapore (Singapore)
Who is the main contact?
Dr Shefaly Shorey
nurssh@nus.edu.sg
Trial website
Contact information
Type
Scientific
Primary contact
Dr Shefaly Shorey
ORCID ID
http://orcid.org/0000-0001-5583-2814
Contact details
Yong Loo Lin School of Medicine
National University of Singapore
Level 2
Clinical Research Center
MD11
10 Medical Drive
Singapore
117597
Singapore
(65) 66011294
nurssh@nus.edu.sg
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NA
Study information
Scientific title
Effectiveness of "home-but not alone" mobile-health application on parental outcomes: A randomized controlled trial
Acronym
Study hypothesis
1. Compared with parents in control group, parents receiving M-Health App intervention will have significantly:
1.1. Higher scores in their parenting efficacy
1.2. Higher satisfaction with the Social Support received
1.3. Higher parenting satisfaction score
1.4. Reduced depression scores
2. There will be a statistically significant difference between mothers and fathers' demographics and their self-efficacy, social support, parenting satisfaction and postnatal depression
Ethics approval
National Health Group Domain Specific Review Board (NHG-DSRB), 11/01/2016, ref: 2015/01250
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Postnatal Parental Outcomes
Intervention
Participating couples are randomly allocated to one of two groups:
Control group: Parents continue to receive standard care only, which involves postnatal support by nurses and lactation consultants while the parents are in the hospital and routine follow-up visit with their obstetrician.
Intervention group: Parents continue to receive standard care, but are also given one months access to the “Home-but not alone”, Mobile-Health Application (M-Health App). Participants are advised to actively use the App and interact with fellow parents via App.
The features of the App are as follows:
1. Asynchronous communication, where the participants can exchange messages and photos to consult midwife pertaining to their queries as well as peer discussion among themselves. This will enable them to receive timely and reliable support in the early postpartum period. The participants will be pre-informed that midwife will respond to their queries once a day for four weeks till they have an access to the M-Health App. However, parents will be reinforced to remain vigilant that this App is an adjunct support to the support received from the hospital and in case of any emergency the hospital will still be the main point of contact.
2. A knowledge-based content consisting of information materials specially focused in enhancing parental self-efficacy, parenting satisfaction, decreasing anxiety and postnatal depression and awareness on social support from both formal and informal sources as well as videos and audios with a search function for easier access to information will be provided.
3. Push Notifications will be automatically issued every 24 hours from the day of discharge from the hospital (Day 4) till day 10 after the birth of the baby. The aim is to provide new parents with information regarding commonly asked questions such as breastfeeding, baby’s bowel moments and jaundice.
Participants in both groups are contact by telephone after four weeks (post-test) when the access to the APP will be terminated to complete a number of questionnaires.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Parenting self-efficacy is measured using the Parent Efficacy Scale (PES) at baseline and 4 weeks.
Secondary outcome measures
1. Parenting satisfaction is measured using the What Being the Parent of a New Baby is Like (WBPL) questionnaire at baseline and 4 weeks
2. Satisfaction with social support is measured using the Perceived Social Support for Parenting (PSSP) questionnaire at baseline and 4 weeks
3. Postnatal depression is measured using the Edinburgh Postnatal Depression Scale (EPDS) at baseline and 4 weeks
Overall trial start date
28/12/2015
Overall trial end date
17/08/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 21 years or above
2. Able to read and speak English
3. Have a smart gadget with internet connection to download the M-Health Application named "Home but not Alone"
4. Will be staying in Singapore for first four weeks after the birth of their new-born
5. Have a full-term health baby who will be discharged home with the parents
6. In a physical and emotional stable condition at the time of data collection
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
118 couples with 59 couples in each arm
Participant exclusion criteria
1. Have physical or mental disorders, which will interfere with their ability to participate in the data collection
2. Have newborns with deformities and/or complications and/or disabilities
3. Have their newborns admitted to Neonatal Intensive Care Unit
Recruitment start date
01/01/2016
Recruitment end date
31/12/2016
Locations
Countries of recruitment
Singapore
Trial participating centre
National University Hospital
5 Lower Kent Ridge Road
Singapore
119074
Singapore
Sponsor information
Organisation
National University of Singapore
Sponsor details
National University of Singapore
21 Lower Kent Ridge Road
Singapore
119077
Singapore
+65 6516 6666
enquiry@nus.edu.sg
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
National University of Singapore
Alternative name(s)
NUS
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Singapore
Results and Publications
Publication and dissemination plan
Planned publication of at least two manuscripts in peer reviewed journals.
Intention to publish date
30/09/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28276086