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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Postnatal Depression, Self Efficacy, Parent-Child Relations, Development, Child, Anxiety, Parenting Satisfaction

Intervention / Treatment
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* Other: Supportive Parenting Application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard hospital care with follow up + Supportive Parenting App<br>Receive standard hospital care and follow up, and access to the Supportive Parenting App from pregnancy to 6 months postpartum | Other: Supportive Parenting Application<br>* 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<br>|
| No Intervention: Standard hospital care with follow up<br>Receive standard hospital care with follow up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months postpartum | 
| 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 | 12 months postpartum | 
| 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 | 2 months postpartum | 
| 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 | 4 months postpartum | 
| 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 | 6 months postpartum | 
| 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 | 9 months postpartum | 
| 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 | 12 months postpartum | 
| Paternal depression | Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome | 1 month postpartum | 
| Paternal depression | Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome | 2 month postpartum | 
| Paternal depression | Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome | 4 month postpartum | 
| Paternal depression | Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome | 6 month postpartum | 
| Paternal depression | Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome | 9 month postpartum | 
| Paternal depression | Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome | 12 month postpartum | 
| Parental Anxiety | State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes. | 1 month postpartum | 
| Parental Anxiety | State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes. | 2 month postpartum | 
| Parental Anxiety | State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes. | 4 month postpartum | 
| Parental Anxiety | State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes. | 6 month postpartum | 
| Parental Anxiety | State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes. | 9 month postpartum | 
| Parental Anxiety | State-Trait Anxiety Scale (STAI) minimum score of 20 and maximum score of 80, with higher scores indicating worse outcomes. | 12 month postpartum | 
| Parenting self-efficacy | Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy | 1 month postpartum | 
| Parenting self-efficacy | Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy | 2 month postpartum | 
| Parenting self-efficacy | Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy | 4 month postpartum | 
| Parenting self-efficacy | Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy | 6 month postpartum | 
| Parenting self-efficacy | Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy | 9 month postpartum | 
| Parenting self-efficacy | Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy | 12 month postpartum | 
| 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. | 1 month postpartum | 
| 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. | 2 month postpartum | 
| 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. | 4 month postpartum | 
| 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. | 6 month postpartum | 
| 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. | 9 month postpartum | 
| 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. | 12 month postpartum | 
| Parent-Infant bonding | Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding | 1 month postpartum | 
| Parent-Infant bonding | Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding | 2 month postpartum | 
| Parent-Infant bonding | Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding | 4 month postpartum | 
| Parent-Infant bonding | Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding | 6 month postpartum | 
| Parent-Infant bonding | Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding | 9 month postpartum | 
| Parent-Infant bonding | Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding | 12 month postpartum | 
| 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. | 1 month postpartum | 
| 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. | 2 month postpartum | 
| 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. | 4 month postpartum | 
| 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. | 6 month postpartum | 
| 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. | 9 month postpartum | 
| 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. | 12 month postpartum |