EMPHIS - A Feasibility Study (version 1)
Research type
Research Study
Full title
Emergency Medicine and Psychology Head Injury Study - a study to evaluate the feasibility of delivering a randomised controlled trial assessing the effectiveness of an online education and advice intervention for parents in modifying psychological outcomes after mild traumatic brain injury in young children.
IRAS ID
162019
Contact name
Mark Lyttle
Contact email
Sponsor organisation
UHBristol NHS Foundation Trust
Duration of Study in the UK
0 years, 8 months, 2 days
Research summary
Childhood head injury is extremely common, with almost half a million attendances to Emergency Departments (ED) every year. A substantial proportion display features of concussion, or mild traumatic brain injury (mTBI). Fortunately, mTBI largely resolves with no intervention, but in a significant minority it is a keystone condition associated with a number of potential adverse consequences in the short, medium and long term. These include physical, behavioural and cognitive issues which may co-exist in the same individual (post-concussion syndrome; PCS), and may lead to difficulty in social re-integration and violent criminal behaviour. These are evident even when other factors including environment and family set-up are taken into account; mTBI and PCS therefore place considerable burden on the patient and family, and contribute to parental distress.
These adverse effects may be modifiable through early application of simple advice-based interventions. Given the nature of the health care journey of children with mTBI, any such intervention must be easy to deliver and access, while meeting the needs of the family and improving quality of care. Through this feasibility study we propose to ascertain utility and acceptability of an enhanced discharge package of advice and information for families of young children with mTBI, and assess the deliverability of a definitive study. This package will include standard advice on the acute post-injury phase, but will also contain information on PCS for families, including features in very young children, suggested coping and caring strategies, and information on accessing necessary services.
On completion of this feasibility study we aim to assess the impact of the intervention in a definitive multi-centre study. Given the size of the problem throughout the UK, a small positive effect from this low cost intervention has the potential to translate to large scale and long-term benefits to the population as a whole.
REC name
Wales REC 7
REC reference
16/WA/0159
Date of REC Opinion
25 May 2016
REC opinion
Favourable Opinion