A Psycho-educational Intervention to Improve Family Mental Health and Child Educational Outcomes Following Admission to PICU: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- The Number of Feasibility Criteria Successfully Met
研究概览
简要总结
- Evaluate the feasibility and acceptability of an information based intervention delivered to parents following their child's admission to paediatric intensive care;
- Evaluate the feasibility and acceptability of the study design and procedures;
- Explore the effects of the intervention on parent and child psychological outcomes 3-6 months post discharge from PICU;
- Explore the effects of parental stress experienced during PICU admission on the effectiveness of the intervention;
- To provide data that, combined with results from other studies, could inform the sample size for a future multi-site RCT.
详细描述
Most children are now expected to make a complete medical recovery following admission to PICU. However, research suggests that some children will go on to develop psychological difficulties, such as problems with emotions, behaviour, and learning. In addition, parents themselves may suffer with emotional difficulties. Although the follow-up of survivors is recommended, there are currently no specific guidelines in place. Intervention in the early stages of recovery could help families pull through without long lasting after-effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unplanned emergency admissions to PICU for at least 12 hours
- •Parent or primary carer speaks and can read English
排除标准
- •Child dies whilst on ward
- •Child discharged with a terminal illness
- •Child has had multiple PICU admission in the past
- •Staff feel it is inappropriate to approach family
- •Family live overseas
结局指标
主要结局
The Number of Feasibility Criteria Successfully Met
时间窗: 3-6 months post discharge from PICU
Feasibility success criteria have been defined a priori for the intervention and study design. There are six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation. There are also six feasibility criteria related to the study design, covering recruitment rate; participation rate; acceptability of procedures; attrition rate; and the time-scale of data collection. Dependent on the number of criteria successfully met, the following classification will be used: "\*" 0-2/6 criteria met - Stop; intervention and/or study design not feasible. "\*" 3-4/6 criteria met - Continue with modifications; feasible intervention and/or study design with modifications. "\*" 5/6 criteria met - Continue without modifications, but monitor closely; feasible intervention and/or study design with close monitoring. "\*" 6/6 criteria met - Continue without modifications; feasible intervention and/or study design as is.
次要结局
- Impact of Events Scale (IES)(3-6 months post discharge from PICU)
- Hospital Anxiety and Depression Scale (HADS)(3-6 months post discharge from PICU)