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

2022년 4월 4일 업데이트: 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

연구 개요

연구 유형

중재적

등록 (실제)

398

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

21년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
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
간섭 없음: Standard hospital care with follow up
Receive standard hospital care with follow up

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Maternal postpartum depression
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Infant physical, social, and emotional development
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Shefaly Shorey, PhD, National University of Singapore

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 3월 1일

기본 완료 (실제)

2022년 3월 22일

연구 완료 (실제)

2022년 3월 22일

연구 등록 날짜

최초 제출

2021년 1월 7일

QC 기준을 충족하는 최초 제출

2021년 1월 10일

처음 게시됨 (실제)

2021년 1월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 4월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 4월 4일

마지막으로 확인됨

2022년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • NHG DSRB 2019/00875

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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