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

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706442
• Other study ID #: NHG DSRB 2019/00875
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 22, 2022

Study information

• Verified date: April 2022
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: March 22, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Singapore	Alice Lee Centre for Nursing Studies	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Paternal depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	1 month postpartum
Secondary	Paternal depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	2 month postpartum
Secondary	Paternal depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	4 month postpartum
Secondary	Paternal depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	6 month postpartum
Secondary	Paternal depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	9 month postpartum
Secondary	Paternal depression	Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome	12 month postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Parenting self-efficacy	Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy	1 month postpartum
Secondary	Parenting self-efficacy	Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy	2 month postpartum
Secondary	Parenting self-efficacy	Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy	4 month postpartum
Secondary	Parenting self-efficacy	Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy	6 month postpartum
Secondary	Parenting self-efficacy	Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy	9 month postpartum
Secondary	Parenting self-efficacy	Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy	12 month postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Parent-Infant bonding	Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding	1 month postpartum
Secondary	Parent-Infant bonding	Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding	2 month postpartum
Secondary	Parent-Infant bonding	Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding	4 month postpartum
Secondary	Parent-Infant bonding	Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding	6 month postpartum
Secondary	Parent-Infant bonding	Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding	9 month postpartum
Secondary	Parent-Infant bonding	Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding	12 month postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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