AzTrials
AzTrials

Postnatal DepressionNCT04706442

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

A study testing Supportive Parenting Application in people with Postnatal Depression and Self Efficacy, run by National University of Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
What is being tested?
Supportive Parenting Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
398 participants
Where
1 siteSingapore
Study dates
1 Mar 2020to 22 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Alice Lee Centre for Nursing Studies

    Singapore, 117597

Other trials in Singapore

About this study

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

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:

Read more
  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
Being tested
Supportive Parenting Application
Medical subject headings
Depression, Postpartum, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT04706442
Study groupRoleWhat they receive
Standard hospital care with follow up + Supportive Parenting AppExperimentalReceive standard hospital care and follow up, and access to the Supportive Parenting App from pregnancy to 6 months postpartum
Receives: Other: Supportive Parenting Application
Standard hospital care with follow upNo interventionReceive standard hospital care with follow up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal postpartum depression

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

    Measured: 1 month postpartum

  2. Maternal postpartum depression

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

    Measured: 2 month postpartum

  3. Maternal postpartum depression

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

    Measured: 4 months postpartum

  4. Maternal postpartum depression

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

    Measured: 6 months postpartum

  5. Maternal postpartum depression

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

    Measured: 9 months postpartum

  6. Maternal postpartum depression

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

    Measured: 12 months postpartum

Secondary outcomes (43)
  1. 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

    Measured: 6 months postpartum

  2. 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

    Measured: 12 months postpartum

  3. 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

    Measured: 2 months postpartum

  4. 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

    Measured: 4 months postpartum

  5. 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

    Measured: 6 months postpartum

  6. 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

    Measured: 9 months postpartum

  7. 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

    Measured: 12 months postpartum

  8. Paternal depression

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

    Measured: 1 month postpartum

  9. Paternal depression

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

    Measured: 2 month postpartum

  10. Paternal depression

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

    Measured: 4 month postpartum

  11. Paternal depression

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

    Measured: 6 month postpartum

  12. Paternal depression

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

    Measured: 9 month postpartum

  13. Paternal depression

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

    Measured: 12 month postpartum

  14. Parental Anxiety

    State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.

    Measured: 1 month postpartum

  15. Parental Anxiety

    State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.

    Measured: 2 month postpartum

  16. Parental Anxiety

    State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.

    Measured: 4 month postpartum

  17. Parental Anxiety

    State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.

    Measured: 6 month postpartum

  18. Parental Anxiety

    State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.

    Measured: 9 month postpartum

  19. Parental Anxiety

    State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes.

    Measured: 12 month postpartum

  20. Parenting self-efficacy

    Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy

    Measured: 1 month postpartum

  21. Parenting self-efficacy

    Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy

    Measured: 2 month postpartum

  22. Parenting self-efficacy

    Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy

    Measured: 4 month postpartum

  23. Parenting self-efficacy

    Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy

    Measured: 6 month postpartum

  24. Parenting self-efficacy

    Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy

    Measured: 9 month postpartum

  25. Parenting self-efficacy

    Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy

    Measured: 12 month postpartum

  26. 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.

    Measured: 1 month postpartum

  27. 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.

    Measured: 2 month postpartum

  28. 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.

    Measured: 4 month postpartum

  29. 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.

    Measured: 6 month postpartum

  30. 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.

    Measured: 9 month postpartum

  31. 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.

    Measured: 12 month postpartum

  32. Parent-Infant bonding

    Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding

    Measured: 1 month postpartum

  33. Parent-Infant bonding

    Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding

    Measured: 2 month postpartum

  34. Parent-Infant bonding

    Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding

    Measured: 4 month postpartum

  35. Parent-Infant bonding

    Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding

    Measured: 6 month postpartum

  36. Parent-Infant bonding

    Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding

    Measured: 9 month postpartum

  37. Parent-Infant bonding

    Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding

    Measured: 12 month postpartum

  38. 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.

    Measured: 1 month postpartum

  39. 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.

    Measured: 2 month postpartum

  40. 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.

    Measured: 4 month postpartum

  41. 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.

    Measured: 6 month postpartum

  42. 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.

    Measured: 9 month postpartum

  43. 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.

    Measured: 12 month postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2021
  2. Study start1 Mar 2020
  3. Primary completion22 Mar 2022
  4. Study completion22 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
398 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04706442
Sponsor's protocol ID
NHG DSRB 2019/00875
Status last verified
Apr 2022
First submitted
7 Jan 2021
Last updated
12 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38822693
  • 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.

    PubMed 36811952
  • 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.

    PubMed 36645699

Questions about this trial

What is this clinical trial studying?

A study testing Supportive Parenting Application in people with Postnatal Depression and Self Efficacy, run by National University of Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal postpartum depression (time frame: 1 month postpartum). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04706442, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.

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