Condition category
Not Applicable
Date applied
29/02/2016
Date assigned
03/03/2016
Last edited
01/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

academic

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes