跳至主要内容
临床试验/NCT02091804
NCT02091804已完成不适用

Promoting First Relationships: A Strengths-based Primary Prevention Project in a Native Community

University of Washington2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Change in Quality of caregiver-child interactions from baseline at 3 months and 6 months

研究概览

简要总结

The purpose of this study is to to conduct a randomized controlled trial comparing an intervention group and a control/wait list group to evaluate the feasibility of the Promoting First Relationships method in an American Indian community through their tribal Maternal and Child Health program, and to assess the efficacy of the method in this community.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Primary caregiver for a child aged 10 to 30 months
  • Caregiver lives with the child full time for the past three months and plans to continue for at least 6 more months.
  • Child is an American Indian or Alaska Native living on or near the Tribe's reservation.
  • Caregiver has telephone access
  • Caregiver is willing to have researchers come to their house
  • Caregiver is English speaking
  • Caregiver is willing to participate in a home-visiting program which includes video-recorded sessions of caregivers and their children playing
  • Exclusion Criteria--Caregiver is
  • hospitalized or imprisoned
  • living in a Treatment facility or shelter
  • unable to give consent
  • live in a household that already has a dyad enrolled in the study.

排除标准

  • 未提供

结局指标

主要结局

Change in Quality of caregiver-child interactions from baseline at 3 months and 6 months

时间窗: Baseline, 3-month and 6-month follow-ups

We are using the Nursing Child Assessment Satellite Training Teaching Scales to assess quality of caregiver-child interactions. Caregivers select an activity that their child cannot perform, such as drawing, and spend up to 5 minutes teaching this activity to the child. The interaction is video-recorded and coded for the caregiver's sensitivity to cues, response to distress, and fostering of social, emotional, and cognitive growth, as well as for the child's clarity of cues and responsiveness to the caregiver.

次要结局

  • Change in Caregiver helplessness from baseline at 3 months and 6 months(Baseline, 3-month and 6-month follow-ups)
  • Change in Caregiver stress from baseline at 3 months and 6 months(Baseline, 3-month and 6-month follow-ups)
  • Change in Child Social-emotional Competence from baseline at 3 months and 6 months(Baseline, 3-month and 6-month follow ups)

研究者

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

Cathryn Booth-LaForce

Professor, Dept. of Family and Child Nursing

University of Washington

研究点 (2)

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