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

maanantai 4. huhtikuuta 2022 päivittänyt: Shefaly Shorey, National University of Singapore

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:

  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

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

398

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Singapore
      • Singapore, Singapore, 117597
        • Alice Lee Centre for Nursing Studies

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

21 vuotta - 65 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Joo

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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
Muut: 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
Ei väliintuloa: Standard hospital care with follow up
Receive standard hospital care with follow up

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Maternal postpartum depression
Aikaikkuna: 1 month postpartum
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
Aikaikkuna: 2 month postpartum
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
Aikaikkuna: 4 months postpartum
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
Aikaikkuna: 6 months postpartum
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
Aikaikkuna: 9 months postpartum
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
Aikaikkuna: 12 months postpartum
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
12 months postpartum

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Infant physical, social, and emotional development
Aikaikkuna: 6 months postpartum
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
Aikaikkuna: 12 months postpartum
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
Aikaikkuna: 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
2 months postpartum
Infant physical, social, and emotional development
Aikaikkuna: 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
4 months postpartum
Infant physical, social, and emotional development
Aikaikkuna: 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 months postpartum
Infant physical, social, and emotional development
Aikaikkuna: 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
9 months postpartum
Infant physical, social, and emotional development
Aikaikkuna: 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
12 months postpartum
Paternal depression
Aikaikkuna: 1 month postpartum
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
1 month postpartum
Paternal depression
Aikaikkuna: 2 month postpartum
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
2 month postpartum
Paternal depression
Aikaikkuna: 4 month postpartum
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
4 month postpartum
Paternal depression
Aikaikkuna: 6 month postpartum
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
6 month postpartum
Paternal depression
Aikaikkuna: 9 month postpartum
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
9 month postpartum
Paternal depression
Aikaikkuna: 12 month postpartum
Edinburgh Postnatal Depression Scale (EPDS) Minimum score is 0, maximum score is 30, with higher score indicating worse outcome
12 month postpartum
Parental Anxiety
Aikaikkuna: 1 month postpartum
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
Aikaikkuna: 2 month postpartum
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
Aikaikkuna: 4 month postpartum
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
Aikaikkuna: 6 month postpartum
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
Aikaikkuna: 9 month postpartum
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
Aikaikkuna: 12 month postpartum
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
Aikaikkuna: 1 month postpartum
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
1 month postpartum
Parenting self-efficacy
Aikaikkuna: 2 month postpartum
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
2 month postpartum
Parenting self-efficacy
Aikaikkuna: 4 month postpartum
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
4 month postpartum
Parenting self-efficacy
Aikaikkuna: 6 month postpartum
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
6 month postpartum
Parenting self-efficacy
Aikaikkuna: 9 month postpartum
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
9 month postpartum
Parenting self-efficacy
Aikaikkuna: 12 month postpartum
Parenting Efficacy Scale (PES) Scores range from 10 to 40 with higher scores indicating higher parenting efficacy
12 month postpartum
Perceived social support
Aikaikkuna: 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.
1 month postpartum
Perceived social support
Aikaikkuna: 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.
2 month postpartum
Perceived social support
Aikaikkuna: 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.
4 month postpartum
Perceived social support
Aikaikkuna: 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.
6 month postpartum
Perceived social support
Aikaikkuna: 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.
9 month postpartum
Perceived social support
Aikaikkuna: 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.
12 month postpartum
Parent-Infant bonding
Aikaikkuna: 1 month postpartum
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
1 month postpartum
Parent-Infant bonding
Aikaikkuna: 2 month postpartum
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
2 month postpartum
Parent-Infant bonding
Aikaikkuna: 4 month postpartum
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
4 month postpartum
Parent-Infant bonding
Aikaikkuna: 6 month postpartum
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
6 month postpartum
Parent-Infant bonding
Aikaikkuna: 9 month postpartum
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
9 month postpartum
Parent-Infant bonding
Aikaikkuna: 12 month postpartum
Parent-to-Infant Bonding Scale scores range from 0 to 24, with higher scores indicating worse bonding
12 month postpartum
Parenting satisfaction
Aikaikkuna: 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.
1 month postpartum
Parenting satisfaction
Aikaikkuna: 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.
2 month postpartum
Parenting satisfaction
Aikaikkuna: 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.
4 month postpartum
Parenting satisfaction
Aikaikkuna: 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.
6 month postpartum
Parenting satisfaction
Aikaikkuna: 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.
9 month postpartum
Parenting satisfaction
Aikaikkuna: 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.
12 month postpartum

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

National University of Singapore

Tutkijat

  • Päätutkija: Shefaly Shorey, PhD, National University of Singapore

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Muut tutkimustunnusnumerot

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Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

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Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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