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临床试验/NCT02294968
NCT02294968Unknown不适用

The Family Startup Program. A Randomized Controlled Trial of a Universal Group-based Parenting Support Program

University of Aarhus2 个研究点 分布在 1 个国家目标入组 1,719 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,719
试验地点
2
主要终点
The Parenting Sense of Competence scale (PSOC)

研究概览

简要总结

The aims of this study are to determine whether a group-based parent support program ("Family Startup") can lead to early improved parental sense of competence, family relations, and child development. Evaluation is based on a randomized controlled trial, with half of the participants receiving Family Startup and the other half receiving treatment as usual.

详细描述

Some knowledge exists about effectiveness of high-intensity delivery of parenting support to subsets of at risk families. To the best of our knowledge, however, little is known about effects of universal primary prevention programs.

The Family Startup Program is a structured format for implementing pre- and postnatal parenting support groups that prepare new families for their roles as parents as well as focus on enhancing parents' social network. The Family Startup Program gathers couples in groups and introduces participants to informal sources of support (e.g. by meeting and interacting with other new families) and to a broad range of community resources (e.g. financial advisers, child dentist, local solicitors, family counselors) providing them with information and parenting skills. The program content includes handling family finance, choice of paternity leave, couple communication, breastfeeding, network formation, ensuring dental health, sensitivity toward child signals, child rearing discipline, help-seeking behavior, home safety, and more.

A second formulated rational behind the program is that strengthening father involvement, social network formation and access to family services will serve to enhance family relationships, including parenting, coparenting and couple relationship quality. Through participation in Family Startup, families receive a long term connection with a health visitor in the community and are introduced to a broad range of community services. This can be expected to benefit optimal health service utility and ease access to resources for families and children with need. Improved child outcome are the ultimate goal. No scientific evaluation of program effects of the Family Startup program on child or family outcome was previously conducted.

研究设计

研究类型
Interventional
分配方式
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

  • Parents, mothers as well as their partners, expecting their first child in the municipality of Aarhus are eligible for the study. This is because of the universal nature of the original program. Mothers are included if interested regardless of the fathers' decline. Biological fathers, registered partners, as well as non-registered partners are eligible.

排除标准

  • Parents are excluded from the study if they are under the age of 18 years
  • Not capable of managing own legal affairs
  • Choose not to accept any routine pregnancy scans. These exclusion criteria are chosen to secure that study participants are legally responsible and that we are able to recruit them via the Department of Obstetrics and Gynaecology in connection with the nuchal translucency scan around week 12
  • The father or partner is not included if the mother declines participation. The mother can choose to attend the Family Startup Program with a friend (i.e. a sister, friend or neighbor) but friends are not eligible for the study
  • Finally, individuals are excluded if they are not able to understand the Danish oral presentation of the study information and hence cannot give informed consent

结局指标

主要结局

The Parenting Sense of Competence scale (PSOC)

时间窗: measured when child is 9 months

次要结局

  • Couple Satisfaction Index(measured when child is 9 months)
  • Coparenting Relationship Scale(measured when child is 9 months)
  • The Parenting Sense of Competence scale (PSOC)(measured when child is 18 months)
  • Parenting Stress Scale(measured when child is 9 months)
  • Breastfeeding duration(Duration before child is 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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