Children and young people (age 6-18 years) with epilepsy are at risk for poor health outcomes, including generally reduced quality of life and psychological problems. Better self-management of their medical needs supports improved quality of life and mental health outcomes. Thus, support to enhance self-management of medical needs is a priority. However, there is an acute shortage of clinical psychologists, and healthcare professionals could benefit patients by being able to deliver simple interventions to help children and young people’s self-management of epilepsy.
To develop the evidence-base for using Applied Behaviour Analysis interventions in routine clinical practice by various healthcare professionals to improve medical self-management at home for children and young people with epilepsy. In the proposed feasibility study, we will focus on the theoretical development, modeling, and exploratory trial (corresponding to Phases I, II, III of the MRC framework for complex intervention evaluation) building the evidence for a subsequent pragmatic randomized clinical trial (RCT).
1. To undertake (a) a systematic review of the effectiveness of self-management interventions to promote appropriate use of medication and other medical self-care procedures by young people with epilepsy, and to identify appropriate outcomes and outcome measures, and (b) a broader mixed-method realist synthesis of what works for whom and in what circumstances concerning promotion of self-management of epilepsy by young people.
2. To develop and test the feasibility of intervention(s) to promote self-management and better medicines management, delivered by a variety of staff in routine primary care and clinical practice settings.
3. To develop a protocol for a pragmatic randomised controlled trial
The study will utilise the 2001 and 2008, MRC Framework for developing complex interventions in public health settings as a guiding methodological framework.
Self-management interventions in the context of paediatric healthcare are based on the principles of psychological learning theory. The application of these principles to address socially significant human behaviour is known as the field of Applied Behaviour Analysis (ABA). ABA methods are individualised but built on common features. In this context, task analysis would be used to establish the small steps that comprise a medical self-management procedure. Each step is then individually taught to the young person with regular feedback on successful completion of tasks using positive reinforcement procedures. An ABA approach would be designed to teach self-management skills and increase motivation to engage with on-going medical self-management. An advantage of ABA methods is that the techniques can be adapted for young people of varying cognitive abilities. Children with specific deficits in memory can be included as can those with a generalised learning disability.
There is a growing body of international literature demonstrating that research implementation is influenced by the nature of, and perceptions about the evidence being implemented, the context of implementation, as well as individual behaviour. The Promoting Action on Research Implementation in Health Services (PARIHS) framework represents some of these complexities, and will be used as this study’s theoretical framework to inform implementation.
Children and young people with epilepsy aged 6-18 years, their parents and their healthcare professionals will be recruited from BCUHB and linked services at Walton Hospital, Liverpool.
A three phase study is planned:
Phase 1. Manual development
1.1 Systematic review and meta-analysis of the effectiveness of epilepsy self-management interventions in children and young people age 6-18 years using Cochrane principles, and to identify appropriate outcomes and outcome measures, and mixed-method realist synthesis of what works, for whom and in what contexts to establish the broader context for developing and implementing the intervention in routine care.
1.2 Survey of children/young people, parents and epilepsy professionals in participating BCUHB and Walton Hospital epilepsy services to identify the most challenging self-management problems.
1.3 Sheila Lewis plus local clinical epilepsy experts will then work with ABA professionals to develop task analysis and intervention model for one or two key problems.
1.4 Synthesis of findings 1.1-3 and write-up of ABA manualised intervention.
Phase 2 - Feasibility study
A small RCT will be conducted with the support of the North Wales Clinical Trials Unit to directly test the feasibility of the proposed intervention, along with the parameters that are crucial in designing a future full-scale RCT.
Objectives. To test: (a) the feasibility of the manualised intervention, (b) the recruitment pathways, (c) the recruitment, adherence, and compliance rates, (d) the effectiveness of outcome measures in capturing changes in epilepsy management behaviors and self-efficacy of young people, and (e) the feasibility of an economic evaluation of the cost effectiveness of the ABA intervention, with particular consideration of the measurement of short and medium term outcomes (health related quality and self-efficacy).
Proposed sample: In line with Health Technology Assessment guidance the aim will be to recruit a minimum of 20 children and young people age 6-18 years with epilepsy. The children will be randomized in two balanced groups: ABA intervention group and comparison group (usual care).
Phase 3 - Protocol development for a full pragmatic RCT including
• Power analysis and sample size estimation.
• Participant inclusion/exclusion criteria;
• Exact procedure for participant recruitment and randomization to groups, including a set of study documentation such as information sheets and consent forms;
• Participant characteristics: including assessments of severity of impact of self-management problems pre-intervention;
• Complete description of intervention: healthcare professional training method, steps of implementation phase (using the new ABA intervention manual), treatment integrity/fidelity, content of ‘comparison’ – usual care;
• Outcome measures and reliability assessments;
• Statistical analysis and effect size determination;
• Follow-up procedures;
• Design of fully integrated economic analysis;
• Integrated knowledge translation and dissemination approach.
Ethics: Approval will be sought from the relevant NHS and University ethics committees.
1. Systematic review and realist synthesis (1 or 2 publications)
2. Peer reviewed articles reporting theoretical and feasibility work to design and pilot self-management interventions
3. Manual for a ABA epilepsy self-management intervention for children and young people for use in routine clinical practice
4. Protocol for a pragmatic RCT for submission to a funder
Alignment to NISCHR AHSC research priorities
The proposal addresses two priority areas of excellence: mental health and public health/ primary care.
Epilepsy is a long-term, life-limiting neurological condition. The negative stigma associated with epilepsy means children and young people frequently experience stigmatising behaviours enacted by peers. Misunderstanding about epilepsy negatively impacts on coping with daily self-care and it is common for young people to experiment with not taking medicine as prescribed or engaging in unhealthy lifestyle choices.
This proposal serves to address service delivery and organisation in both primary and secondary care, and organisational issues, to promote optimal self-care at home and optimal translation and implementation of a manualised intervention to promote health, self-efficacy, wellbeing and mental health outcomes in a very challenging neurological condition in childhood and young adulthood.
The proposal aligns with current NISCHR priorities such as early intervention, service delivery and organisation, mental health and children. In challenging economic times, it is recognised that practice developments need to be cost-effective or cost neutral. This proposal includes an economic component and aims to help address an acute shortage of clinical psychology input to routine care by providing multi-disciplinary healthcare professionals with simple psychological-based interventions to deliver in routine care, addressing the most common psychological problems encountered by children and young people. Although this proposal is focused on children and young people with epilepsy, findings may be helpful in planning and delivering services in other long term conditions to improve outcomes for children and maximise use of scarce NHS resources.
LDAN - http://www.ldancymru.org.uk/index.php.en
WhizzKidz - http://www.whizz-kidz.org.uk
Contact a Family - http://www.cafamily.org.uk
Care Co-ordination Cymru - http://www.ccnuk.org.uk
NISCHR - http://www.wales.nhs.uk/sites3/home.cfm
Children and Young People Research network - http://www.link-wales.org.uk/
Epilepsy Wales - http://public.epilepsy-wales.org.uk/
Epilepsy Action - http://www.epilepsy.org.uk/
Epilepsy bereaved. - http://www.sudep.org/