Clinical trial NCT04041401: The Experiences of Children and Caregivers Given PICU Storybooks
Official title: A Paediatric Intensive Care Unit (PICU) 'Storybooks' Intervention for Children and Their Caregivers: a Case-series Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PTSD
Critical Illness
Depression
Anxiety
Quality of Life
Keywords: paediatric intensive care unit
intervention
PTSD
storybook
Narrative
Feasibility
Case-series
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: St George's University Hospitals NHS Foundation Trust
First posted: 2019-08-01
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients and their caregivers admitted to the PICU at St George's Hospital PICU.

Brief summary: 1. To assess the acceptability and feasibility of a study design aimed at evaluating the efficacy of a newly developed intervention for children and their caregivers following discharge from PICU
2. To assess the acceptability of the newly developed 'storybook intervention'

Detailed description: Admission to a Paediatric Intensive Care Unit (PICU) can be extremely stressful for patients and their caregivers. Both are at heightened risk of psychological distress, including post-traumatic stress symptoms (PTSS), which sometimes persist for months or years post-discharge. Unfortunately, few post-PICU psychological interventions have been studied. Documented challenges in PICU research (e.g. low recruitment rates) means feasibility issues require investigation before investing resources in intervention trials.

In adult intensive-care, diaries are used to help patients and families undergo key processes that underpin therapies to reduce PTSS: talking about and understanding their experiences. In the only published study exploring paediatric ICU diaries, families gave positive feedback, but their clinical effectiveness has not yet been evaluated. Further, it is hypothesised that formatting diaries as 'storybooks' is more adaptable to the developmental variation of the paediatric population.

Using a case-series design, this research aims to establish the feasibility of recruiting to a study evaluating PICU storybooks. It will explore the acceptability of research tasks to families, the utility and sensitivity of psychometric measures, plus how storybooks are used and perceived in supporting psychological recovery. It is anticipated that the findings will directly inform the planning of a larger scale evaluation study, and adaptations to the intervention. The hope is this will lead to improved support for families leaving PICU.

Pairs of caregivers and their children aged 3-15 will be recruited upon discharge from a PICU and will receive an individualised, developmentally-appropriate storybook about their PICU experiences. At discharge, and one, three and six months post-discharge, caregivers and children aged 8+ will complete questionnaires about psychological distress symptoms (depression, anxiety and PTSS) and their impact on functioning. Participants will be asked to keep a brief log of their storybook use and will be interviewed about their experience of the intervention and research procedures at three and six months post-discharge.

Eligibility criteria: Inclusion Criteria:

1. Parent-child dyads where the child has been admitted to the St Georges Hospital PICU during the recruitment phase.
2. At time of discharge, the parent is at least 18 years old, and the child is between 3 and 15 years old with an assumed cognitive ability of at least 3 years.
3. Child's admission was at least 24 hours in duration.

Exclusion Criteria:

1. Parent-child dyads that do not meet all inclusion criteria above, or;
2. The child's admission was due to a non-accidental injury or they are known to be the subject of safeguarding concerns within their family;
3. Either the parent or child has a severe visual impairment, or the parent is unable to read.
4. The child is 'Looked after'/in foster care.
5. The child is discharged from PICU to end of life care.
6. Either the parent or child is participating in other intervention research for PICU survivors, is in receipt of psychological therapy in relation to the admission, or has already received a storybook about this most recent PICU admission.

Primary outcomes:
measure: Recruitment and retention rate
timeFrame: 6 months
measure: Questionnaire completion rate
timeFrame: 6 months
measure: Success rate of intervention delivery within 4-6 weeks post-discharge
timeFrame: 6 months
measure: Acceptability of intervention and research participation: qualitative interview
timeFrame: 3 months
measure: Acceptability of intervention and research participation: qualitative interview
timeFrame: 6 months
Secondary outcomes:
measure: Post-traumatic Adjustment Screen (parent participants)
timeFrame: 24 hours
measure: Work and Social Adjustment scale (parent participants; change being assessed)
timeFrame: 24 hours, 1 month, 3 months and 6 months
measure: Paediatric Quality of Life (PedsQL) (child participants; change being assessed)
timeFrame: 24 hours, 1 month, 3 months and 6 months
measure: Strength and Difficulties Questionnaire (SDQ) (child participants; change being assessed)
timeFrame: 24 hours, 1 month, 3 months and 6 months
measure: The Hospital Anxiety and Depression Scale (HADS) (for parent participants; change being assessed)
timeFrame: 24 hours, 1 month, 3 months and 6 months
measure: The PTSD (post traumatic stress disorder) Checklist for DSM (diagnostic statistical manual) 5 (PCL5) (for parent participants; change being assessed)
timeFrame: 1 month, 3 months and 6 months
measure: The Child revised Impact of Events Scale - 8 (CRIES-8) (For child participants; change being assessed)
timeFrame: 1 month, 3 months and 6 months
Other outcomes:
Locations:
city: Tooting
country: United Kingdom
facility: St George's Hospital
Study officials:
affiliation: St George's Hospital Paediatric Psychology
name: Dr Ellie Atkins
role: PRINCIPAL_INVESTIGATOR
References: