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

Primary Purpose

Postnatal Depression, Self Efficacy, Parent-Child Relations

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Supportive Parenting Application
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postnatal Depression

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Alice Lee Centre for Nursing Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Standard hospital care with follow up + Supportive Parenting App

Standard hospital care with follow up

Arm Description

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

Receive standard hospital care with follow up

Outcomes

Primary Outcome Measures

Maternal postpartum depression
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Maternal postpartum depression
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Maternal postpartum depression
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Maternal postpartum depression
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Maternal postpartum depression
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Maternal postpartum depression
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome

Secondary Outcome Measures

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
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
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
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
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
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
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
Paternal depression
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Paternal depression
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Paternal depression
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Paternal depression
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Paternal depression
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Paternal depression
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Parental Anxiety
State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
Parental Anxiety
State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
Parental Anxiety
State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
Parental Anxiety
State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
Parental Anxiety
State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
Parental Anxiety
State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
Parenting self-efficacy
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
Parenting self-efficacy
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
Parenting self-efficacy
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
Parenting self-efficacy
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
Parenting self-efficacy
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
Parenting self-efficacy
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
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.
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.
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.
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.
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.
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.
Parent-Infant bonding
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
Parent-Infant bonding
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
Parent-Infant bonding
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
Parent-Infant bonding
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
Parent-Infant bonding
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
Parent-Infant bonding
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 7, 2021
Last Updated
April 4, 2022
Sponsor
National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT04706442
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
March 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Depression, Self Efficacy, Parent-Child Relations, Development, Child, Anxiety, Parenting Satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
398 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard hospital care with follow up + Supportive Parenting App
Arm Type
Experimental
Arm Description
Receive standard hospital care and follow up, and access to the Supportive Parenting App from pregnancy to 6 months postpartum
Arm Title
Standard hospital care with follow up
Arm Type
No Intervention
Arm Description
Receive standard hospital care with follow up
Intervention Type
Other
Intervention Name(s)
Supportive Parenting Application
Intervention Description
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
Primary Outcome Measure Information:
Title
Maternal postpartum depression
Description
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Time Frame
1 month postpartum
Title
Maternal postpartum depression
Description
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Time Frame
2 month postpartum
Title
Maternal postpartum depression
Description
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Time Frame
4 months postpartum
Title
Maternal postpartum depression
Description
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Time Frame
6 months postpartum
Title
Maternal postpartum depression
Description
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Time Frame
9 months postpartum
Title
Maternal postpartum depression
Description
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Time Frame
12 months postpartum
Secondary Outcome Measure Information:
Title
Infant physical, social, and emotional development
Description
Bayley-IV scale Minimum raw score of 0 and maximum score of 258 for 129 items. Higher score indicate better outcome
Time Frame
6 months postpartum
Title
Infant physical, social, and emotional development
Description
Bayley-IV scale Minimum score of 0 and maximum score of 258 for 129 items. Higher score indicate better outcome
Time Frame
12 months postpartum
Title
Infant physical, social, and emotional development
Description
Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes
Time Frame
2 months postpartum
Title
Infant physical, social, and emotional development
Description
Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes
Time Frame
4 months postpartum
Title
Infant physical, social, and emotional development
Description
Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes
Time Frame
6 months postpartum
Title
Infant physical, social, and emotional development
Description
Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes
Time Frame
9 months postpartum
Title
Infant physical, social, and emotional development
Description
Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes
Time Frame
12 months postpartum
Title
Paternal depression
Description
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Time Frame
1 month postpartum
Title
Paternal depression
Description
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Time Frame
2 month postpartum
Title
Paternal depression
Description
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Time Frame
4 month postpartum
Title
Paternal depression
Description
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Time Frame
6 month postpartum
Title
Paternal depression
Description
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Time Frame
9 month postpartum
Title
Paternal depression
Description
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
Time Frame
12 month postpartum
Title
Parental Anxiety
Description
State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
Time Frame
1 month postpartum
Title
Parental Anxiety
Description
State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
Time Frame
2 month postpartum
Title
Parental Anxiety
Description
State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
Time Frame
4 month postpartum
Title
Parental Anxiety
Description
State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
Time Frame
6 month postpartum
Title
Parental Anxiety
Description
State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
Time Frame
9 month postpartum
Title
Parental Anxiety
Description
State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.
Time Frame
12 month postpartum
Title
Parenting self-efficacy
Description
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
Time Frame
1 month postpartum
Title
Parenting self-efficacy
Description
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
Time Frame
2 month postpartum
Title
Parenting self-efficacy
Description
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
Time Frame
4 month postpartum
Title
Parenting self-efficacy
Description
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
Time Frame
6 month postpartum
Title
Parenting self-efficacy
Description
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
Time Frame
9 month postpartum
Title
Parenting self-efficacy
Description
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
Time Frame
12 month postpartum
Title
Perceived social support
Description
Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.
Time Frame
1 month postpartum
Title
Perceived social support
Description
Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.
Time Frame
2 month postpartum
Title
Perceived social support
Description
Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.
Time Frame
4 month postpartum
Title
Perceived social support
Description
Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.
Time Frame
6 month postpartum
Title
Perceived social support
Description
Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.
Time Frame
9 month postpartum
Title
Perceived social support
Description
Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.
Time Frame
12 month postpartum
Title
Parent-Infant bonding
Description
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
Time Frame
1 month postpartum
Title
Parent-Infant bonding
Description
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
Time Frame
2 month postpartum
Title
Parent-Infant bonding
Description
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
Time Frame
4 month postpartum
Title
Parent-Infant bonding
Description
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
Time Frame
6 month postpartum
Title
Parent-Infant bonding
Description
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
Time Frame
9 month postpartum
Title
Parent-Infant bonding
Description
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
Time Frame
12 month postpartum
Title
Parenting satisfaction
Description
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.
Time Frame
1 month postpartum
Title
Parenting satisfaction
Description
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.
Time Frame
2 month postpartum
Title
Parenting satisfaction
Description
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.
Time Frame
4 month postpartum
Title
Parenting satisfaction
Description
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.
Time Frame
6 month postpartum
Title
Parenting satisfaction
Description
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.
Time Frame
9 month postpartum
Title
Parenting satisfaction
Description
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.
Time Frame
12 month postpartum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shefaly Shorey, PhD
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alice Lee Centre for Nursing Studies
City
Singapore
ZIP/Postal Code
117597
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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

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