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

Sponsor
National University, Singapore (Other)
Overall Status
Completed
CT.gov ID
NCT04706442
Collaborator
(none)
398
1
2
24.7
16.1

Study Details

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:
  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

Condition or Disease Intervention/Treatment Phase
  • Other: Supportive Parenting Application
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
398 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Mar 22, 2022
Actual Study Completion Date :
Mar 22, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Maternal postpartum depression [1 month postpartum]

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

  2. Maternal postpartum depression [2 month postpartum]

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

  3. Maternal postpartum depression [4 months postpartum]

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

  4. Maternal postpartum depression [6 months postpartum]

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

  5. Maternal postpartum depression [9 months postpartum]

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

  6. Maternal postpartum depression [12 months postpartum]

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

Secondary Outcome Measures

  1. Infant physical, social, and emotional development [6 months postpartum]

    Bayley-IV scale Minimum raw score of 0 and maximum score of 258 for 129 items. Higher score indicate better outcome

  2. Infant physical, social, and emotional development [12 months postpartum]

    Bayley-IV scale Minimum score of 0 and maximum score of 258 for 129 items. Higher score indicate better outcome

  3. Infant physical, social, and emotional development [2 months postpartum]

    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. Infant physical, social, and emotional development [4 months postpartum]

    Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes

  5. Infant physical, social, and emotional development [6 months postpartum]

    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. Infant physical, social, and emotional development [9 months postpartum]

    Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes

  7. Infant physical, social, and emotional development [12 months postpartum]

    Ages and Stages Questionnaire - 3 (ASQ-3) 21 items; minimum score of 0 and maximum score of 210, with higher score indicating better outcomes

  8. Paternal depression [1 month postpartum]

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

  9. Paternal depression [2 month postpartum]

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

  10. Paternal depression [4 month postpartum]

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

  11. Paternal depression [6 month postpartum]

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

  12. Paternal depression [9 month postpartum]

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

  13. Paternal depression [12 month postpartum]

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

  14. Parental Anxiety [1 month postpartum]

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

  15. Parental Anxiety [2 month postpartum]

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

  16. Parental Anxiety [4 month postpartum]

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

  17. Parental Anxiety [6 month postpartum]

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

  18. Parental Anxiety [9 month postpartum]

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

  19. Parental Anxiety [12 month postpartum]

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

  20. Parenting self-efficacy [1 month postpartum]

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

  21. Parenting self-efficacy [2 month postpartum]

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

  22. Parenting self-efficacy [4 month postpartum]

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

  23. Parenting self-efficacy [6 month postpartum]

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

  24. Parenting self-efficacy [9 month postpartum]

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

  25. Parenting self-efficacy [12 month postpartum]

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

  26. Perceived social support [1 month postpartum]

    Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.

  27. Perceived social support [2 month postpartum]

    Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.

  28. Perceived social support [4 month postpartum]

    Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.

  29. Perceived social support [6 month postpartum]

    Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.

  30. Perceived social support [9 month postpartum]

    Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.

  31. Perceived social support [12 month postpartum]

    Perceived Social Support for Parenting (PSSP) scale minimum score of 10 and maximum score of 40. Higher score indicate higher perceived support.

  32. Parent-Infant bonding [1 month postpartum]

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

  33. Parent-Infant bonding [2 month postpartum]

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

  34. Parent-Infant bonding [4 month postpartum]

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

  35. Parent-Infant bonding [6 month postpartum]

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

  36. Parent-Infant bonding [9 month postpartum]

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

  37. Parent-Infant bonding [12 month postpartum]

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

  38. Parenting satisfaction [1 month postpartum]

    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.

  39. Parenting satisfaction [2 month postpartum]

    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.

  40. Parenting satisfaction [4 month postpartum]

    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.

  41. Parenting satisfaction [6 month postpartum]

    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.

  42. Parenting satisfaction [9 month postpartum]

    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.

  43. Parenting satisfaction [12 month postpartum]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alice Lee Centre for Nursing Studies Singapore Singapore 117597

Sponsors and Collaborators

  • National University, Singapore

Investigators

  • Principal Investigator: Shefaly Shorey, PhD, National University, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shefaly Shorey, Assistant Professor, National University, Singapore
ClinicalTrials.gov Identifier:
NCT04706442
Other Study ID Numbers:
  • NHG DSRB 2019/00875
First Posted:
Jan 12, 2021
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022