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

This study is currently recruiting participants.
Verified June 2012 by University Hospitals Bristol NHS Trust
Sponsor:
Information provided by (Responsible Party):
Sarah Goodwin, University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier:
NCT01628263
First received: June 21, 2012
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Post Traumatic Stress Disorder
 Other: Follow up Clinic for High risk participants

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Does Screening Parents Allow Targeting of a Paediatric Intensive Care Follow-up Clinic? A Feasibility Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospitals Bristol NHS Trust:

Primary Outcome Measures:
  • The Impact of Event Scale-Revised (IES-R) [ Time Frame: 5 months post discharge ] [ Designated as safety issue: No ]
    Widely used self-report measure of responses to trauma

  • Hospital Anxiety & Depression Scale (HADS) [ Time Frame: 5 months post discharge ] [ Designated as safety issue: No ]
    Widely used self-report measure of anxiety and depression


Secondary Outcome Measures:
  • Feedback Questionnaire [ Time Frame: 6 months post discharge ] [ Designated as safety issue: No ]
    Questionnaire to elicit feelings about taking part in the study including questions about acceptability of completing screening measures and some people being excluded from clinic due to being low risk. Clinic attenders will be asked if they found it a useful experience and how it could be improved.


Estimated Enrollment: 150
Study Start Date: December 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Follow up Clinic
Participants 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.
 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.
No Intervention: Control
Participants will not receive an offer of a follow up clinic
 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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628263

Contacts
Contact: Victoria Samuel 0117 342 8168

Locations
United Kingdom
Bristol Royal Hospital for Children Recruiting
Bristol, United Kingdom, BS2 8BJ
Contact: Victoria Samuel     0117 342 8168        
Sub-Investigator: Victoria Samuel            
Principal Investigator: Sarah Goodwin            
Sponsors and Collaborators
University Hospitals Bristol NHS Trust
Investigators
Principal Investigator: Sarah Goodwin University Hospitals Bristol NHS Foundation Trust
Study Director: Victoria Samuel University Hospitals Bristol NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Sarah Goodwin, Specialist Registrar, University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier: NCT01628263     History of Changes
Other Study ID Numbers: CH/2011/3827
Study First Received: June 21, 2012
Last Updated: June 25, 2012
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service
United Kingdom: National Institute for Health Research

Keywords provided by University Hospitals Bristol NHS Trust:
PICU
Follow up
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013