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临床试验/NCT04635449
NCT04635449Unknown2 期

A Prospective Randomised Controlled Study of a Directed Psycho-educational Tool to Prevent Psychological Sequelae Following Paediatric Intensive Care Admission.

Imperial College Healthcare NHS Trust1 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2021年7月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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