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临床试验/NCT06352229
NCT06352229招募中不适用

The Playful Learning in Infancy Program (PLIP): A Pilot Feasibility Study of an Universal Educational Parenting Program Using a Parallel Group Design

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 2,327 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
2,327
试验地点
2
主要终点
Parental Playful interactions

研究概览

简要总结

In the Playful Learning in Infancy Program, parents receive research-based educational guidance on playful interactions with their infants aged 0-1 year. They learn to recognize their infants' cues indicating readiness to engage in play and they are introduced to specific, developmentally appropriate activities for interactive engagement. The guidance is delivered to parents during routine home visits by public health visitors.

The aims of the Playful Learning in Infancy Program are to 1) promote playful interactions between infants and parents, parental attitudes towards play, and infant socioemotional development; 2) enhance the language and knowledge of playful learning in infancy among frontline staff; and 3) evaluate the Playful Learning in Infancy Program for potential testing in a future large-scale RCT study.

Evaluation is based on a parallel group study design, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Residence address in the Danish municipalities of Hvidovre or Billund
  • Residence address with child or legal custody of the child
  • Child is between 1-7 months old
  • Understands Danish or English

排除标准

  • Parental age under the age of 18 when the child is born
  • Multiple pregnancy

研究组 & 干预措施

Care As Usual

Active Comparator

Postnatal care as usual

干预措施: Postnatal care as usual (Behavioral)

Playful Learning in Infancy Program

Experimental

Playful Learning in Infancy Program plus postnatal care as usual

干预措施: Playful Learning in Infancy Program (Behavioral)

结局指标

主要结局

Parental Playful interactions

时间窗: T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months)

Playful interactions are assessed using The Parent Play Questionnaire (PPQ) by Ahmadzadeh et al. (2020), which assesses the frequency of parent-child play and screen use.

次要结局

  • Infant Socio-emotional Development(T5 (infant age 11-11.5 months))
  • Parental Attachment Style(T1/Enrollment (4 weeks - 8 months))
  • Infant Screen Time(T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months))
  • Infant Level of Play(T4 (infant age 10-10.5 months))
  • Questions developed for the study regarding Parental Knowledge of Play(T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months))
  • Parental Mind-Mindedness(T5 (infant age 11-11.5 months))
  • Parental Experience of the PLIP(Immediately after the intervention)
  • Parental Stress(T3 (infant age 7-7.5 months))
  • Parental Mental Well-Being(T1/Enrollment (4 weeks - 8 months) and T5 (infant age 11-11.5 months))
  • Health Visitors' Experience of the PLIP(Immediately after the intervention)
  • Questions developed for the study regarding Parental Involvement(T2 (infant age 3-3.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 10-10.5 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mette Væver

PhD, Professor

University of Copenhagen

研究点 (2)

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