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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospitals Bristol NHS Foundation Trust.
Recruitment status was  Recruiting
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

June 21, 2012
June 25, 2012
December 2011
July 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01628263 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Post Traumatic Stress Disorder
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.
  • 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.
    Intervention: Other: Follow up Clinic for High risk participants
  • No Intervention: Control
    Participants will not receive an offer of a follow up clinic
    Intervention: Other: Follow up Clinic for High risk participants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
July 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact: Victoria Samuel 0117 342 8168
United Kingdom
 
NCT01628263
CH/2011/3827
No
Sarah Goodwin, University Hospitals Bristol NHS Trust
University Hospitals Bristol NHS Foundation Trust
Not Provided
Principal Investigator: Sarah Goodwin University Hospitals Bristol NHS Foundation Trust
Study Director: Victoria Samuel University Hospitals Bristol NHS Foundation Trust
University Hospitals Bristol NHS Foundation Trust
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP