Clinical trial NCT01628263: Does a Follow-up Appointment Help Parents of Children on PICU?
Official title: Does Screening Parents Allow Targeting of a Paediatric Intensive Care Follow-up Clinic? A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: PICU
Follow up
PTSD
Lead sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 127
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: The Impact of Event Scale-Revised (IES-R)
timeFrame: 5 months post discharge
measure: Hospital Anxiety & Depression Scale (HADS)
timeFrame: 5 months post discharge
Secondary outcomes:
measure: Feedback Questionnaire
timeFrame: 6 months post discharge
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
Study officials:
affiliation: University Hospitals Bristol and Weston NHS Foundation Trust
name: Sarah Goodwin
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Bristol and Weston NHS Foundation Trust
name: Victoria Samuel
role: STUDY_DIRECTOR
References: