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Does a Follow-up Appointment Help Parents of Children on PICU? — PICUfu  

Post Traumatic Stress Disorder Clinical Trial

Official title:
Does Screening Parents Allow Targeting of a Paediatric Intensive Care Follow-up Clinic? A Feasibility Study

Clinical Trial Summary

The aim of our study is to determine the feasibility of carrying out a randomized controlled trial (RCT) to investigate whether screening parents of children admitted to pediatric intensive care unit (PICU) so as to target follow-up at those most at risk of developing posttraumatic stress disorder (PTSD), is effective at reducing adverse psychological sequelae.

Clinical Trial Description

The study will assess the feasibility of offering a follow up clinic to parents identified to be vulnerable for future psychological difficulties after their child's admission to the Paediatric Intensive Care Unit (PICU) at Bristol Children's Hospital. Both mothers and fathers of children admitted to PICY for a duration of at least 12 hours will be invited to participate in this study. Screening measures will be used to identify vulnerability to future post-traumatic stress disorder (PTSD) and depression. Where one or both of the parents has been scored as high risk they will be randomised to receive the intervention or the control arm of the study (ratio 1:1). The intervention involves a follow-up clinic two months pots admission, staffed by the unit Clinical Psychologist, a PICU doctor and PICU nurse. In the control arm no follow-up clinic will be offered (i.e. current standard care). Objectives: i) To investigate the recruitment rates, clinic attendance and follow-up rates in order to perform an accurate sample size calculation for a larger study. ii) To carry out initial statistical analysis to estimate the odds ratio and 95% confidence interval of developing PTSD, anxiety and depression after being offered the follow-up intervention as opposed to not being offered it. iii) To assess the acceptability of providing targeted follow-up both to those who receive it and those who are excluded due to low risk. The study is of importance to the public because not only does PTSD negatively affect quality of life, it is also associated with increased use of health care services and resources. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01628263
Study type Interventional
Source University Hospitals Bristol NHS Foundation Trust
Contact
Status Completed
Phase N/A
Start date December 2011
Completion date May 2013
View Details
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