4PICU
Research type
Research Study
Full title
A prospective randomised controlled study of a directed psycho-educational tool to prevent psychological sequelae following Paediatric Intensive Care admission
IRAS ID
287235
Contact name
Simon Nadel
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
896, NIHR Peer Review
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Most children are now expected to survive admission to Paediatric Intensive Care Units(PICU). However, research suggests that some children will go on to develop psychological difficulties, such as problems with emotions, behaviour, and learning. In addition, a high proportion of parents/guardians may suffer with emotional difficulties and Post Traumatic Stress Disorder (PTSD). Intervention in the early stages of recovery could help families pull through without long-lasting after effects. We have developed an innovative educational intervention, based on our previous pilot study, which we now want to test in a larger cohort.
This Trial aims to:
1) Systematically evaluate age-specific information, complemented by a follow-up targeted telephone call to reduce psychological sequelae in the child and their parents/guardians after PICU discharge.
2) Evaluate the effects of the intervention on parent and child emotional adjustment 6 months after PICU discharge; and explore whether these outcomes are associated with the child’s age; the effect of the targeted telephone call; and/or with parental stress during the child’s admission.
We will recruit children of all ages admitted to PICU. After informed consent parents/guardians will be randomized to receive either active intervention or treatment as usual. Prior to discharge from PICU, a parental stress screening questionnaire will be given to all parents/guardians.
Those randomised to the intervention group will be given the psycho-educational tool prior to discharge, and will be informed about the targeted telephone call to be delivered 4-6 weeks later. Those in the treatment as usual group will not get the intervention.
Validated, age-appropriate questionnaires will be used to assess PTSD and anxiety symptoms in parents/guardians and children, and additional behavioural difficulties in children, six months after PICU discharge. These tools will allow us to assess the effect of the intervention on PTSD symptoms, anxiety, depression and on the behavioural and emotional welfare of parents/guardians and their child.REC name
London - Central Research Ethics Committee
REC reference
20/LO/1272
Date of REC Opinion
7 Jan 2021
REC opinion
Further Information Favourable Opinion