NCT01628263

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
OTHER	Follow up Clinic for High risk participants	Families where either or both parents are screened to be at risk of PTSD or depression are randomised in a 1:1 ratio to the intervention or control arm. Those in the intervention arm will receive an offer of a follow up clinic two months post discharge, staffed by the unit Clinical Psychologist, a PICU doctor and PICU nurse. Those in the control arm will not be offered a follow up clinic.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-06-26
• Last updated: 2020-11-27

Locations

1 site across 1 country: United Kingdom