Effectiveness of 'Supportive Parenting App' on Parental and Newborn Outcomes

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

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

Study Overview

• Status: Completed
• Conditions: Anxiety; Parent-Child Relations; Self Efficacy; Development, Child; Postnatal Depression; Parenting Satisfaction
• Intervention / Treatment: Other: Supportive Parenting Application

• Study Type: Interventional
• Enrollment (Actual): 398
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117597
    • Alice Lee Centre for Nursing Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard hospital care with follow up + Supportive Parenting App; Receive standard hospital care and follow up, and access to the Supportive Parenting App from pregnancy to 6 months postpartum	Other: Supportive Parenting Application; The Supportive Parenting Application is a theory-based perinatal educational intervention for couples administered through a mobile application. The mobile app consist of knowledge-based content, informational videos and audio, discussion forum, chat groups with peer volunteers, and an experts advice section
No Intervention: Standard hospital care with follow up; Receive standard hospital care with follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal postpartum depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	1 month postpartum
Maternal postpartum depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	2 month postpartum
Maternal postpartum depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	4 months postpartum
Maternal postpartum depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	6 months postpartum
Maternal postpartum depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	9 months postpartum
Maternal postpartum depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	12 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant physical, social, and emotional development	Bayley-IV scale Minimum raw score of 0 and maximum score of 258 for 129 items. Higher score indicate better outcome	6 months postpartum
Infant physical, social, and emotional development	Bayley-IV scale Minimum score of 0 and maximum score of 258 for 129 items. Higher score indicate better outcome	12 months postpartum
Infant physical, social, and emotional development	Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes	2 months postpartum
Infant physical, social, and emotional development	Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes	4 months postpartum
Infant physical, social, and emotional development	Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes	6 months postpartum
Infant physical, social, and emotional development	Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes	9 months postpartum
Infant physical, social, and emotional development	Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes	12 months postpartum
Paternal depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	1 month postpartum
Paternal depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	2 month postpartum
Paternal depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	4 month postpartum
Paternal depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	6 month postpartum
Paternal depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	9 month postpartum
Paternal depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	12 month postpartum
Parental Anxiety	State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.	1 month postpartum
Parental Anxiety	State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.	2 month postpartum
Parental Anxiety	State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.	4 month postpartum
Parental Anxiety	State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.	6 month postpartum
Parental Anxiety	State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.	9 month postpartum
Parental Anxiety	State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.	12 month postpartum
Parenting self-efficacy	Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy	1 month postpartum
Parenting self-efficacy	Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy	2 month postpartum
Parenting self-efficacy	Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy	4 month postpartum
Parenting self-efficacy	Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy	6 month postpartum
Parenting self-efficacy	Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy	9 month postpartum
Parenting self-efficacy	Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy	12 month postpartum
Perceived social support	Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.	1 month postpartum
Perceived social support	Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.	2 month postpartum
Perceived social support	Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.	4 month postpartum
Perceived social support	Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.	6 month postpartum
Perceived social support	Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.	9 month postpartum
Perceived social support	Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.	12 month postpartum
Parent-Infant bonding	Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding	1 month postpartum
Parent-Infant bonding	Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding	2 month postpartum
Parent-Infant bonding	Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding	4 month postpartum
Parent-Infant bonding	Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding	6 month postpartum
Parent-Infant bonding	Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding	9 month postpartum
Parent-Infant bonding	Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding	12 month postpartum
Parenting satisfaction	What Being the Parent of a New Baby is Like Questionnaire (WPBL) 11-items, scores range from 0 to 99 with higher scores indicating better parenting satisfaction.	1 month postpartum
Parenting satisfaction	What Being the Parent of a New Baby is Like Questionnaire (WPBL) 11-items, scores range from 0 to 99 with higher scores indicating better parenting satisfaction.	2 month postpartum
Parenting satisfaction	What Being the Parent of a New Baby is Like Questionnaire (WPBL) 11-items, scores range from 0 to 99 with higher scores indicating better parenting satisfaction.	4 month postpartum
Parenting satisfaction	What Being the Parent of a New Baby is Like Questionnaire (WPBL) 11-items, scores range from 0 to 99 with higher scores indicating better parenting satisfaction.	6 month postpartum
Parenting satisfaction	What Being the Parent of a New Baby is Like Questionnaire (WPBL) 11-items, scores range from 0 to 99 with higher scores indicating better parenting satisfaction.	9 month postpartum
Parenting satisfaction	What Being the Parent of a New Baby is Like Questionnaire (WPBL) 11-items, scores range from 0 to 99 with higher scores indicating better parenting satisfaction.	12 month postpartum

Collaborators and Investigators

• Sponsor: National University of Singapore
• Investigators: Principal Investigator: Shefaly Shorey, PhD, National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): March 22, 2022
• Study Completion (Actual): March 22, 2022

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 10, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: NHG DSRB 2019/00875

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No