Title: Cerebral visual impairment in primary school age children: prevalence, impact and effectiveness of support
Funder: Department of Health and Social Care

Abstract: Background, Aim and Research Questions Cerebral Visual Impairment (CVI) refers to impairment of vision due to malfunction of the brain, rather than the eyes. CVI is a feature of many neurodevelopmental conditions, affects an estimated 1% of children and results in learning, co-ordination and communication difficulties. Descriptive studies report that simplifying visual input improves performance in children with CVI but robust data are lacking. CVI is often unrecognised as many affected children have good visual acuity and appear to see normally. We have designed a complex intervention, involving school and hospital components, for children with CVI. The over-arching aim of this research programme is to refine and evaluate the intervention. The research questions are: What is the estimated prevalence of CVI in primary school children? What is the yield of children with CVI obtained by examining all children with SEN, or children with abnormal parent and/or teacher reported scores in a standard questionnaire? Which existing assessment tools are useful for children with CVI? What additional aspects of functioning or experience do children, families and teachers report as impacted by CVI? Is a clusterrandomised RCT to assess this intervention feasible? Design and Methods Firstly we will conduct a cross-sectional survey in 10 primary schools and 2 special schools. We will identify children with CVI by offering a detailed CVI assessment at the local eye clinic for all children with special educational needs (SEN) and also for children who have abnormal scores in the parent or teacher report versions of the Strengths and Difficulties Questionnaire (SDQ). We will interview teachers about their knowledge of CVI and their professional learning needs and preferences. Secondly we will carry out a systematic review to identify assessment tools already used for children with CVI. We will collect new data from parents, children and teachers about the impact of CVI. We will map the outcomes to the World Health Organisation (WHO) International Classification of Functioning and Disability (ICF) and use this as part of defining a core set of outcomes to be measured in trials involving children with CVI. Thirdly we will use these data in the design of a feasibility cluster-randomised controlled trial (RCT) to assess the CVI service. We will recruit 16 primary schools and 2 special schools and randomize them into 2 groups. One group will be offered the new CVI service and the other will continue with usual care. The schools allocated to the new service will be offered educational material about CVI for their staff and detailed CVI-clinic assessments at the local eye clinic, with individualised reports, for children identified as at risk by the best case-finding method from project 1. Outcome collection in both groups of schools will include the SDQ, the core set of outcomes from project 2 and linked data from school and health databases to allow longer-term tracking of relevant outcomes. We will measure the effectiveness and acceptability of the methods to deliver the intervention and to conduct the trial and we will estimate the effect size of the intervention. Summary of Benefits Patients (children with CVI) will benefit immediately as the impact of CVI on their lives will be better understood as will the effectiveness of methods identifying them in primary school. If the intervention is effective and adopted then they will have better educational, developmental and mental health outcomes. If not then unhelpful procedures can be abandoned. The NHS will benefit if the burden of dependency and poor mental health caused by CVI is lessened. NHS commissioners will know ultimately whether the service is cost-effective and should be commissioned.

Lay abstract: Background, Aims and DesignBackground - What is the Problem? Children with Cerebral Visual impairment (CVI) have problems seeing the world. This can appear as an inability to find things, an inability to copy or to understand worksheets, as being clumsy, or as losing concentration because they can't move their eyes accurately. CVI is a part of many conditions affecting children's development and is often hidden as many affected children have reasonable visual acuity and so appear to see normally. Their behaviour may be interpreted as naughtiness, poor concentration or lack of understanding and so the child may be punished or set back academically. This puts them at risk of anxiety, frustration and poor developmental progress. There are reports that simple interventions like making school materials easier to see does help children with CVI but there is little firm evidence for this so access to help at present is haphazard and inequitable.The aim develop and assess new service for CVI We have developed a service for children with CVI that includes the hospital sharing general information about CVI and strategies to help with the schools and offering specialist assessments and reports with individualised advice for at-risk children. In this research programme we will refine and improve the service. We will find out how many children in primary schools do have CVI and the impact of the condition on them and their families. We will design a feasibility study for a randomised trial to examine the effectiveness of the new service. Design and MethodsFirstly we will conduct a survey in 10 primary schools and 2 special schools. We will offer a specialised CVI assessment to all children with special educational needs (SEN) and to any additional children identified in parent or teacher questionnaires as having difficulties. We will ask teachers what they know about CVI and what format they would like for advice about CVI. Secondly we will systematically review the literature and interview parents, carers and children about the impact of CVI in children's daily lives. We will define a core set of aspects of life that should be assessed when trying to decide how helpful an intervention for CVI might be. Thirdly we will use the information from the first two studies to design a feasibility study for a randomised controlled trial (RCT) to assess the CVI service. One group of primary schools will be offered the CVI service and another group of similar primary schools will not. We will collect similar information from schools in both groups at the start and end of the study We will explore setting up linkages to track the children's school and health outcomes in later years. We will look to see whether the new service has brought any advantages or disadvantages for children with CVI, or for the rest of the children. We will calculate how acceptable and effective the research methods were and what changes would be needed for a full size trial. PPI (Patient and Public Involvement) Parents have been closely involved in the design of these research projects. They have contributed to the choice of which ages of children to involve, which methods to use to collect information, how to judge the implementation of the service and which outcomes we should use to measure the effects. They will be further involved in reviewing letters and information sheets, and interpreting and disseminating the results. Dissemination We will offer the results from the research to doctors, eye care professionals, teachers and therapists in scientific papers and meetings in the UK and abroad. We will disseminate the results to families in newsletters and parent support group websites and social media. We will hold public meetings and events, will give talks in schools and create teaching aids such as DVDs and information sheets to distribute as appropriate. Anticipated Benefits This research will benefit patients (children with CVI) immediately as their needs will be better recognised. If the intervention is effective, they will have better educational and social experiences at school and achieve their potential better. NHS practitioners will benefit if they know of effective interventions to help their patients and the NHS will benefit if children need fewer supportive services and develop fewer mental health problems. NHS Commissioners will benefit as they will know whether this is a cost-effective service that they should commission.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;4.3 INFLUENCES AND IMPACT
Health categories: EYE;NEUROLOGICAL