Title: The clinical and cost-effectiveness of Teen Online Problem Solving for adolescents who have survived an acquired brain injury in the UK (TOPS-UK): A feasibility study
Funder: Department of Health and Social Care

Abstract: Background: Paediatric acquired brain injury (pABI) is a leading cause of death and disability worldwide (WHO, 2008). Traumatic brain injury (TBI) is the most common cause of pABI, with approximately 280 children per 100,000 requiring at least 24-hours hospital care each year in the UK (Hawley et al., 2003). TBI is the focus of most clinical-research studies, despite approximately 40,000 children surviving other brain injuries such as brain tumour and stroke, annually in the UK. pABI leads to long-term neuropsychological consequences including difficulties with cognition (e.g., problem-solving), communication, emotion, behaviour, and social function, however, there is limited research investigating treatments for survivors of pABI (Ross et al., 2011). As a result, children with pABI, and their families, have limited, or no, access to appropriate evidence-based clinical services in the UK (e.g., Limond et al., 2014). Members of our research team have developed a web-based problem-solving treatment to target common difficulties experienced by children and families following TBI (Teen Online Problem-Solving, TOPS; Wade et al., 2014; Kurowski et al., 2013). To date, research has demonstrated clinical efficacy (using RCTs) in the USA, with treatment gains on measures of executive functioning, emotion, behaviour, and caregiver distress. We do not know, however, whether the same level of clinical effectiveness can be achieved when TOPS is delivered to adolescents who have survived injuries caused by aetiologies other than TBI (e.g., brain tumour, stroke), whether TOPS can be delivered in the NHS, or whether TOPS is cost effective. Before a definitive RCT can be conducted to address these questions, we first propose a smaller study to determine if a full RCT is feasible. Aims: This feasibility and acceptability study aims to determine the following: i) recruitment rate; ii) willingness of participants to be randomised; iii) treatment adherence; iv) parent, adolescent, and therapist acceptability of the treatment sessions and outcome measures; v) study attrition rates; and vii) feasibility of accessing information related to treatment set-up and delivery costs/resource use. The study will also build on the use of existing quality of life measures to calculate QALYs specific to pABI. Method: We will recruit 50 adolescents aged 12&ndash;16 years with pABI who are at least 12 months post-injury, and their parents. As NHS care pathways for pABI differ across the country, potential participants will be recruited via clinical services in the South of England (Exeter, Southampton, Oxford) and East of England (Cambridge, Leicester), during an 8-month period to extrapolate the recruitment period for a sufficient sample size for a fully powered study, and to identify leading sites for the full RCT. Following screening assessments (executive function), characterisation and baseline assessments (quality of life, social participation, family coping, child behaviour and emotion), participants will be randomised to 10-weeks of treatment as usual (TAU) plus TOPS (weekly online sessions plus video-call with trained therapist) versus TAU-only. Outcome measures (baseline measures plus acceptability measures and telephone interview) will be administered within a week of completing the treatment, and at 6-month post-treatment (the planned follow-up period for the full RCT to assess if any treatment gains are maintained). Potential benefit to patients and the NHS: The findings will inform the design of a definitive multi-site RCT, which will be the first in the UK to evaluate a neuropsychological treatment for adolescents with pABI. If clinical and cost effectiveness are demonstrated in the large study, then this will lead to changes in service delivery throughout the UK in both NHS and third sector. Information gathered on TAU might also inform service delivery for adolescents with pABI, given the current lack of evidence-based treatments.

Lay abstract: In the UK a child injures their brain every 30 minutes. These injuries can be caused by accidents or illnesses. Most children survive; however, this can have a devastating and life-long impact on the child and their family. Brain injury can affect thinking, emotion, behaviour, and relationships, which can impair the child s ability to cope with school, home life, future employment, and independence. Families are also more likely to experience mental health difficulties and parental separation, which can further affect how well a child recovers. Members of the research team have developed an internet-based treatment for children who have survived brain injuries caused by accidents. The treatment teaches problem-solving skills in response to specific everyday difficulties. It is used at home for 10-weeks with weekly therapist support. Research in the USA suggests that adolescents who completed treatment, compared to adolescents who were given general self-help, improved in their ability to plan, organise, problem-solve, and manage their mood and behaviour. Families also experienced less stress and better mental health. A number of questions remain: will the treatment have similar beneficial effects for all types of brain injury such as stroke, infection, tumour? Will the treatment lead to other benefits such as improved quality of life? Finally, as the research has only been carried out in the USA, does the treatment offer value-for-money for the NHS? Before conducting a large multi-site study to answer these questions, we aim to undertake a smaller study to find out how feasible a large study would be. We will ask: i) can we identify and recruit adolescents and families via the NHS? ii) do adolescents and families find the treatment and research measures acceptable? We hope that the research findings will lead to effective, value-for-money, easy-to-access treatments for adolescents following brain injury and their families.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CANCER AND NEOPLASMS;MENTAL HEALTH;INJURIES AND ACCIDENTS;STROKE