A Prospective Randomised Controlled Study of a Directed Psycho-educational Tool to Prevent Psychological Sequelae Following Paediatric Intensive Care Admission.
试验速览
- 阶段
- 2 期
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- post-traumatic stress symptoms in the parents/guardians
研究概览
简要总结
- To systematically evaluate an innovative directed psycho-educational intervention consisting of written specific, age-appropriate information, complemented by a follow-up targeted telephone call in order to reduce psychological sequelae in the child and their parents/guardians after PICU discharge.
- To confirm the effects of the psycho-educational tool on parent and child emotional adjustment 6 months after PICU discharge; and to explore whether these outcomes are associated with the child's age; with receipt of the targeted telephone call; and/or with parental levels of stress during the child's admission.
- To obtain detailed feedback from parents/guardians and children about the different aspects of the psycho-educational intervention (the written information and the targeted telephone call) and the utility of these two psycho-educational interventions.
The study team will perform a randomised controlled trial of the intervention vs treatment as usual in children 0-16 years, stratified according to age (< 4 years and > 4 years).
It is estimated that 288 children will be required to show a difference in outcome which is PTSD in parents and children.
详细描述
STUDY OBJECTIVES AND PURPOSE
Aims
- To systematically evaluate an innovative directed psycho-educational intervention consisting of written specific, age-appropriate information, complemented by a follow-up targeted telephone call in order to reduce psychological sequelae in the child and their parents/guardians after PICU discharge.
- To confirm the effects of the psycho-educational tool on parent and child emotional adjustment 6 months after PICU discharge; and to explore whether these outcomes are associated with the child's age; with receipt of the targeted telephone call; and/or with parental levels of stress during the child's admission.
- To obtain detailed feedback from parents/guardians and children about the different aspects of the psycho-educational intervention (the written information and the targeted telephone call) and the utility of these two psycho-educational interventions.
Primary Objective To determine if the psycho-educational intervention is superior to treatment as usual in reducing parental post-traumatic stress and other psychological symptoms measured at 6 months after PICU discharge.
Secondary Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children and young people age 0-16 years
- •> 36 weeks corrected gestational age
- •Admitted to PICU >24 hours Parent(s)/guardian aged >18 years
排除标准
- •• Children where treatment withdrawal is being considered
- •Life expectancy <6 months
- •Previous admission to Paediatric, or Neonatal Intensive Care for > 24 hours, in the last 12months preceding the current PICU admission
- •Parent(s)/ guardian to have insufficient English to complete questionnaires
- •Overseas address
结局指标
主要结局
post-traumatic stress symptoms in the parents/guardians
时间窗: 6 months post PICU discharge
measured using the Impact of Events Scale, a self-report questionnaire
次要结局
- Parent/guardian general emotional state(6 months post PICU discharge)
- Child post-traumatic stress and other emotional and behavioural problems(6 months post PICU discharge)
