Clinical trial NCT04706442: Effectiveness of 'Supportive Parenting App' on Parental and Newborn Outcomes
Official title: Evaluate the Effectiveness and Cost-effectiveness of 'Supportive Parenting App' a Mobile Based Application on Parental and Newborn Outcomes: A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postnatal Depression
Self Efficacy
Parent-Child Relations
Development, Child
Anxiety
Parenting Satisfaction
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 398
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Supportive Parenting App is a theory-based perinatal educational intervention for couples administered through a mobile application. The intervention comprise of knowledge-based content, informational videos and audio, discussion forum, peer volunteer chat group, and a frequently asked questions (FAQ) expert advice section.

The aims of the study are to:

1. develop theory-based supportive parenting App (SPA) intervention for both first-time and experienced parents across perinatal period
2. examine its effectiveness on parental outcomes: including maternal depression at 12 months postpartum (primary outcome), paternal depression, parental anxiety, parenting self-efficacy, help - seeking behavior (social support), parental bonding and parenting satisfaction (secondary outcomes); and new-born outcomes: physical, social and emotional developments (secondary outcomes)
3. evaluate SPA's cost-effectiveness as compared to standard perinatal care across major restructured hospitals, and
4. examine the perceptions of parents in receiving this intervention.

When compared with those in the control group receiving standard care:

1. parents receiving SPA intervention will have better- emotional well-being (reduced depression and anxiety);parenting self-efficacy; social support; bonding and satisfaction.
2. new-borns of parents receiving SPA will have better physical, social and emotional development
3. It will be more cost-effective to provide SPA than the standard care


Eligibility criteria: Inclusion Criteria:

* able to read and speak English
* have low-risk singleton pregnancy with more than 24 weeks of gestation (age of viability)
* have smartphone with internet access

Exclusion Criteria:

* have physical or mental disorders which would interfere with their ability to participate in the study
* have high-risk pregnancy including placenta-previa major, pre-eclampsia, pregnancy induced hypertension etc.
* have complicated assisted delivery such as vacuum or forceps with 4th degree perineal tear of the mother; and /or
* give birth to a newborn at still-birth or a newborn with congenital anomalies and/or medical complications including pathological jaundice, that required special care in hospital.

Primary outcomes:
measure: Maternal postpartum depression
timeFrame: 1 month postpartum
measure: Maternal postpartum depression
timeFrame: 2 month postpartum
measure: Maternal postpartum depression
timeFrame: 4 months postpartum
measure: Maternal postpartum depression
timeFrame: 6 months postpartum
measure: Maternal postpartum depression
timeFrame: 9 months postpartum
measure: Maternal postpartum depression
timeFrame: 12 months postpartum
Secondary outcomes:
measure: Infant physical, social, and emotional development
timeFrame: 6 months postpartum
measure: Infant physical, social, and emotional development
timeFrame: 12 months postpartum
measure: Infant physical, social, and emotional development
timeFrame: 2 months postpartum
measure: Infant physical, social, and emotional development
timeFrame: 4 months postpartum
measure: Infant physical, social, and emotional development
timeFrame: 6 months postpartum
measure: Infant physical, social, and emotional development
timeFrame: 9 months postpartum
measure: Infant physical, social, and emotional development
timeFrame: 12 months postpartum
measure: Paternal depression
timeFrame: 1 month postpartum
measure: Paternal depression
timeFrame: 2 month postpartum
measure: Paternal depression
timeFrame: 4 month postpartum
measure: Paternal depression
timeFrame: 6 month postpartum
measure: Paternal depression
timeFrame: 9 month postpartum
measure: Paternal depression
timeFrame: 12 month postpartum
measure: Parental Anxiety
timeFrame: 1 month postpartum
measure: Parental Anxiety
timeFrame: 2 month postpartum
measure: Parental Anxiety
timeFrame: 4 month postpartum
measure: Parental Anxiety
timeFrame: 6 month postpartum
measure: Parental Anxiety
timeFrame: 9 month postpartum
measure: Parental Anxiety
timeFrame: 12 month postpartum
measure: Parenting self-efficacy
timeFrame: 1 month postpartum
measure: Parenting self-efficacy
timeFrame: 2 month postpartum
measure: Parenting self-efficacy
timeFrame: 4 month postpartum
measure: Parenting self-efficacy
timeFrame: 6 month postpartum
measure: Parenting self-efficacy
timeFrame: 9 month postpartum
measure: Parenting self-efficacy
timeFrame: 12 month postpartum
measure: Perceived social support
timeFrame: 1 month postpartum
measure: Perceived social support
timeFrame: 2 month postpartum
measure: Perceived social support
timeFrame: 4 month postpartum
measure: Perceived social support
timeFrame: 6 month postpartum
measure: Perceived social support
timeFrame: 9 month postpartum
measure: Perceived social support
timeFrame: 12 month postpartum
measure: Parent-Infant bonding
timeFrame: 1 month postpartum
measure: Parent-Infant bonding
timeFrame: 2 month postpartum
measure: Parent-Infant bonding
timeFrame: 4 month postpartum
measure: Parent-Infant bonding
timeFrame: 6 month postpartum
measure: Parent-Infant bonding
timeFrame: 9 month postpartum
measure: Parent-Infant bonding
timeFrame: 12 month postpartum
measure: Parenting satisfaction
timeFrame: 1 month postpartum
measure: Parenting satisfaction
timeFrame: 2 month postpartum
measure: Parenting satisfaction
timeFrame: 4 month postpartum
measure: Parenting satisfaction
timeFrame: 6 month postpartum
measure: Parenting satisfaction
timeFrame: 9 month postpartum
measure: Parenting satisfaction
timeFrame: 12 month postpartum
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Alice Lee Centre for Nursing Studies
Study officials:
affiliation: National University of Singapore
name: Shefaly Shorey, PhD
role: PRINCIPAL_INVESTIGATOR
References: