跳至主要内容
临床试验/NCT02002780
NCT02002780撤回2 期

Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems

The Hospital for Sick Children2 个研究点 分布在 1 个国家开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
2 期
状态
撤回
试验地点
2
主要终点
Change in psychosocial stress scores resulting from the intervention

研究概览

简要总结

This research project has two goals. The first goal is to find one or more questionnaires that can accurately identify children who are experiencing high levels of stress or emotional health issues during a regular clinic visit. The second goal is to find out whether children who are experiencing stress or emotional health problems are able to attend a day camp programme and complete activities at home that are designed to help them cope better with stress. We also want to find out if the day camp and home activities are helpful.

详细描述

This research will investigate the psychological stress experienced by children who have had surgery for a complex heart problem. Measures of quality of life among children with heart problems indicate that those 8 to 12 years of age have lower quality of life scores than younger or older children.

Children who survive a critical illness requiring a multi-day stay in a pediatric intensive care unit are at risk for a variety of psychiatric morbidities. Depression, anxiety and post-traumatic stress disorder occur in 7% to 28% of patients.

A systematic review of psychological adjustment among children with heart problems indicates that parent reports (but not child self-reports) are useful in detecting problems with psychological adjustment. While parent reports tend to identify increased social and behaviour problems, child self-reports indicate more frequent symptoms of depression compared to healthy peers.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children who have had surgery for a complex heart problem
  • children with heart problems requiring on-going medical care
  • age 6 to 12 years

排除标准

  • the child has had an intervention (catheterization or surgery) within the previous 6 months,
  • the child has an identified cognitive or emotional health disability,
  • the child or parents do not speak English sufficiently well to respond to the screening instruments, or
  • the child's clinic visit is for an acute illness or change in health status.

结局指标

主要结局

Change in psychosocial stress scores resulting from the intervention

时间窗: Baseline and end of study (at about month 10 -11)

次要结局

未报告次要终点

研究者

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

Brian McCrindle

Staff Cardiologist

The Hospital for Sick Children

研究点 (2)

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