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临床试验/NCT04162626
NCT04162626已完成不适用

New Families- Innovation and Development of the Child Health Services in Oslo

VID Specialized University2 个研究点 分布在 1 个国家目标入组 428 人开始时间: 2018年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
428
试验地点
2
主要终点
Self-Efficacy in fathers 6 weeks postpartum

研究概览

简要总结

The New Families (NF) program will improve quality of existing services, secure personalised service and early intervention in Child Health Service (CHS) in Oslo. The study will measure the effects of a primary prevention family-centered healthcare intervention in Norwegian CHS.

详细描述

The New Families (NF) program will improve quality of existing services, secure personalised service and early intervention in Child Health Service (CHS) in Oslo. The study will: 1) Measure the effects of a primary prevention family-centered healthcare intervention in Norwegian CHS, 2) Create case studies from CHS praxis advancing Public Health Nurse (PHN) training and education in Oslo and Norway, 3) Establish a model for how to include users in service development in CHS, 4) Enhance the knowledge base of the PHN practice in CHS Anticipated results: The project will bolster the knowledge base for education and professional practices within the service by strengthen the existing research within the field. The anticipated results of the project are that the intervention will increase maternal and parental self-efficacy, reduce the risk of postpartum depression among first-time mothers, reduce parental stress, increase social support, improve maternal attachment, improve generic health status, improve partner relationship and improve child development compared with usual care. The intervention research in this project can be a future model for service improvement in the CHS.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First time parents living in the chosen districts

排除标准

  • All other parents

结局指标

主要结局

Self-Efficacy in fathers 6 weeks postpartum

时间窗: 6 weeks postpartum

Perceived Maternal Parenting Self-Efficacy (PMP S-E) 20 items. score 22-88. A higher score indicates a higher level of maternal self-efficacy

Self-Efficacy in mothers 3 months postpartum

时间窗: 3 months postpartum

Perceived Maternal Parenting Self-Efficacy (PMP S-E) 20 items. score 22-88. A higher score indicates a higher level of maternal self-efficacy

Depression in mothers in pregnancy

时间窗: 28 weeks pregnancy

Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.

Depression in fathers when partner is pregnant

时间窗: 28 weeks pregnancy

Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.

Depression in mothers three months postpartum

时间窗: 3 months postpartum

Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.

Depression in fathers three months postpartum

时间窗: 3 months postpartum

Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.

Sense of Coherence in mothers in pregnancy

时间窗: 28 weeks pregnancy

Sense of Coherence Scale (SOC 13). 26 items. Score 13-90. Higher score is positive, score under 66 is low.

Sense of Coherence in fathers in pregnancy

时间窗: 28 weeks pregnancy

Sense of Coherence Scale (SOC 13). 26 items. Score 13-90. Higher score is positive, score under 66 is low.

Sense of Coherence in mothers three months postpartum

时间窗: 3 months postpartum

Sense of Coherence Scale (SOC 13). 26 items. Score 13-90. Higher score is positive, score under 66 is low.

Sense of Coherence in fathers three months postpartum

时间窗: 3 months postpartum

Sense of Coherence Scale (SOC 13). 26 items. Score 13-90. Higher score is positive, score under 66 is low.

Self-Efficacy in mothers 6 weeks postpartum

时间窗: 6 weeks postpartum

Perceived Maternal Parenting Self-Efficacy (PMP S-E) 20 items. score 22-88. A higher score indicates a higher level of maternal self-efficacy

Self-Efficacy in fathers 3 months postpartum

时间窗: 3 months postpartum

Perceived Maternal Parenting Self-Efficacy (PMP S-E) 20 items. score 22-88. A higher score indicates a higher level of maternal self-efficacy

Parental Stress in fathers 3 months postpartum

时间窗: 3 months postpartum

Parental Stress Scale (PSS) is formatted in the form of an 18-item self-report scale. Items represent positive (e.g. emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. A higher score indicates a higher level of parental stress.

Parental Stress in mothers 3 months postpartum

时间窗: 3 months postpartum

Parental Stress Scale (PSS) is formatted in the form of an 18-item self-report scale. Items represent positive (e.g. emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. A higher score indicates a higher level of parental stress.

Quality of Life in women and men during pregnancy and postpartum

时间窗: Pregnancy week 28, 3 months postpartum, 12 months postpartum.

To explore first-time parents' QoL during pregnancy and first-time mothers QoL postpartum, and to evaluate the difference in QoL between mothers in the intervention and control districts. Instrument: WHOQOL-BREF, 26-item. Score 4-20, higher scores indicate higher QoL.

次要结局

  • What are the barriers and facilitators to implementation of the PHN intervention?(The interviews will take place about 12 months postpartum)

研究者

发起方
VID Specialized University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kari Glavin

Professor

VID Specialized University

研究点 (2)

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