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临床试验/NCT03898700
NCT03898700已完成不适用

Coaching in Context for Caregivers of Children With Spinal Cord Injury

Thomas Jefferson University5 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2018年9月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
5
主要终点
Change in Canadian Occupational Performance Measure (COPM)

研究概览

简要总结

This pilot study has two aims. The first aim is to establish the feasibility of coaching for caregivers of youth with spinal cord injury, and the second aim is to establish methodological procedures for a future multi-center study on the effectiveness of coaching as an intervention for caregivers of youth with spinal cord injury.

详细描述

This study addresses the unmet needs of female primary informal caregivers of youth with spinal cord injury. A one-group pre-post treatment design will be used. Consented caregivers will receive coaching via face-to-face or via the phone. Each caregiver will participate in up to 10 coaching sessions. Each coaching session will last up to 90 minutes. Coaching sessions will be audiorecorded and transcribed verbatim. Outcomes of coaching on caregivers' self-identified goals will be assessed using the Canadian Occupational Performance Measure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • female primary caregiver of youth between 6-13 years of age with traumatic spinal cord injury
  • female primary caregivers have legal guardianship of their child with spinal cord injury
  • speak, read and comprehend English
  • be available for face-to-face coaching
  • have a cell phone with text messaging capabilities, and willing to utilize cell or land line for coaching and data collection
  • able to verbalize changes in their own participation or their child's participation during initial screen
  • written consent

排除标准

  • severe mental health condition of female caregiver, as documented in child's medical record or reported to research staff by child's treating MD or medical team member
  • abuses illicit or prescribed substances or alcohol at time of initial screen as documented in child's medical record or reported to research staff by child's treating MD or medical team member

结局指标

主要结局

Change in Canadian Occupational Performance Measure (COPM)

时间窗: Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline)

Rates self perceived performance and satisfaction with self-identified goals on a 10 point likert scale (1 cannot do, not satisfied; 10 can do without a problem, very satisfied). A 2-point change is considered clinically meaningful.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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