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Completed

NCT Number: NCT04706442

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

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

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Key information

Conditions

Postnatal Depression Anxiety Anxiety Disorders Depression, Postpartum Depressive Disorder Development, Child Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Parent-Child Relations Parenting Satisfaction Pregnancy Complications Puerperal Disorders Self Efficacy Urogenital Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alice Lee Centre for Nursing Studies

Singapore, 117597

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supportive Parenting Application

Other

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 outcomes

  1. Maternal postpartum depression

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 12 months postpartum

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

Secondary outcomes

  1. Infant physical, social, and emotional development

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 1 month postpartum

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

  21. Parenting self-efficacy

    Time frame: 2 month postpartum

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

  22. Parenting self-efficacy

    Time frame: 4 month postpartum

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

  23. Parenting self-efficacy

    Time frame: 6 month postpartum

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

  24. Parenting self-efficacy

    Time frame: 9 month postpartum

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

  25. Parenting self-efficacy

    Time frame: 12 month postpartum

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

  26. Perceived social support

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 1 month postpartum

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

  33. Parent-Infant bonding

    Time frame: 2 month postpartum

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

  34. Parent-Infant bonding

    Time frame: 4 month postpartum

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

  35. Parent-Infant bonding

    Time frame: 6 month postpartum

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

  36. Parent-Infant bonding

    Time frame: 9 month postpartum

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

  37. Parent-Infant bonding

    Time frame: 12 month postpartum

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

  38. Parenting satisfaction

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2021
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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