Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 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
- 否
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.
研究组 & 干预措施
Subjects
Children identified during the screening phase of the project as having elevated, but not clinically defined, levels of psychosocial stress will be invited to participate in the intervention phase of this research if they are between 8 and 11 years of age.
Screening will identify 6 girls and 6 boys eligible and willing to participate in the intervention phase of the project.
干预措施: Day Camp (Behavioral)
Control
All families that were screened during the screening phase of this study will complete the final screening instrument assessment, whether or not the child participated in the day camp intervention. The control group will be comprised of those families that did not participate in the intervention.
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
Brian McCrindle
Staff Cardiologist
The Hospital for Sick Children