NCT04706442

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. 1.develop theory-based supportive parenting App (SPA) intervention for both first-time and experienced parents across perinatal period
  2. 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. 3.evaluate SPA's cost-effectiveness as compared to standard perinatal care across major restructured hospitals, and
  4. 4.examine the perceptions of parents in receiving this intervention.
  5. 5.parents receiving SPA intervention will have better- emotional well-being (reduced depression and anxiety);parenting self-efficacy; social support; bonding and satisfaction.
  6. 6.new-borns of parents receiving SPA will have better physical, social and emotional development
  7. 7.It will be more cost-effective to provide SPA than the standard care

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
398

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2022

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

January 7, 2021

Last Update Submit

April 4, 2022

Conditions

Postnatal DepressionSelf EfficacyParent-Child RelationsDevelopment, ChildAnxietyParenting Satisfaction

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (43)

  • Infant physical, social, and emotional development

    6 months postpartum

  • Infant physical, social, and emotional development

    12 months postpartum

  • Infant physical, social, and emotional development

    2 months postpartum

  • Infant physical, social, and emotional development

    4 months postpartum

  • Infant physical, social, and emotional development

    6 months postpartum

  • +38 more secondary outcomes

Study Arms (2)

Standard hospital care with follow up + Supportive Parenting App

EXPERIMENTAL

Receive standard hospital care and follow up, and access to the Supportive Parenting App from pregnancy to 6 months postpartum

Other: Supportive Parenting Application

Standard hospital care with follow up

NO INTERVENTION

Receive standard hospital care with follow up

Interventions

Supportive Parenting ApplicationOTHER

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

Standard hospital care with follow up + Supportive Parenting App

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alice Lee Centre for Nursing Studies

Singapore, 117597, Singapore

Location

Related Publications (3)

  • Shorey S, Thilagamangai, Mathews J, Lim SH, Shi L, Chua JS, Du R, Chan YH, Tan TC, Chee C, Chong YS. Effects of Parental Predictors on Postpartum Depression. West J Nurs Res. 2024 Jul;46(7):517-524. doi: 10.1177/01939459241254774. Epub 2024 Jun 1.

    PMID: 38822693DERIVED

  • Shorey S, Chong YS, Shi L, Chua JS; Thilagamangai; Mathews J, Lim SH, Du R, Chan YH, Tan TC, Chee C, Law E. Evaluating the Effects of the Supportive Parenting App on Infant Developmental Outcomes: Longitudinal Study. JMIR Mhealth Uhealth. 2023 Feb 22;11:e43885. doi: 10.2196/43885.

    PMID: 36811952DERIVED

  • Shorey S, Law E; Thilagamangai; Mathews J, Lim SH, Shi L, Chua JS, Du R, Chan YH, Tan TC, Chee C, Chong YS. Evaluating the Effectiveness of the Supportive Parenting App on Parental Outcomes: Randomized Controlled Trial. J Med Internet Res. 2023 Jan 16;25:e41859. doi: 10.2196/41859.

    PMID: 36645699DERIVED

MeSH Terms

Conditions

Depression, PostpartumAnxiety Disorders

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Shefaly Shorey, PhD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 12, 2021

Study Start

March 1, 2020

Primary Completion

March 22, 2022

Study Completion

March 22, 2022

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)