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Clinical Trial 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'


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04041401
Study type Observational
Source University of Surrey
Contact
Status Completed
Phase
Start date June 5, 2019
Completion date February 28, 2020

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