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Clinical Trials/NCT01628263
NCT01628263
Completed
N/A

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

University Hospitals Bristol and Weston NHS Foundation Trust1 site in 1 country127 target enrollmentDecember 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post Traumatic Stress Disorder
Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
Enrollment
127
Locations
1
Primary Endpoint
The Impact of Event Scale-Revised (IES-R)
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
May 2013
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Goodwin

Specialist Registrar

University Hospitals Bristol and Weston NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • All parents of children admitted to paediatric intensive care for over 12 hours.

Exclusion Criteria

  • Parents deemed unsuitable for the study by the responsible consultant. This will include families where a child's condition is suspected to result from non-accidental injury or where withdrawal of care is being discussed due to a child's critical condition. Families will be excluded if their child died during or after admission, as these families are already followed up routinely.

Outcomes

Primary Outcomes

The Impact of Event Scale-Revised (IES-R)

Time Frame: 5 months post discharge

Widely used self-report measure of responses to trauma

Hospital Anxiety & Depression Scale (HADS)

Time Frame: 5 months post discharge

Widely used self-report measure of anxiety and depression

Secondary Outcomes

  • Feedback Questionnaire(6 months post discharge)

Study Sites (1)

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