Abstract
BACKGROUND: Cerebral visual impairment (CVI) refers to brain-related vision difficulties, which are often undiagnosed and may lead to poor mental health outcomes. We have developed an intervention to improve mental health outcomes for affected children, and it requires evaluation. The aim of this study was to assess the feasibility of methods proposed for a future definitive cluster randomised trial. METHODS: This 18-month study took place in South West England, UK, between 2019 and 2021 including a 6-month pause due to the COVID pandemic. Participants were children aged 7-10 years in mainstream primary schools and their teachers and parents. We recruited head teachers on behalf of their school. The intervention was a resource pack for teachers explaining about CVI, providing universal and targeted strategies to help children with CVI and the offer of CVI assessments at the local eye clinic. The control schools continued with usual practice. Our objectives were to evaluate the feasibility of recruitment and data collection, attrition, acceptability of the study methods and implementation of the intervention. We conducted a process evaluation including interviews and questionnaires. RESULTS: We sent invitation letters to 297 schools, received responses to 6% and recruited 40% of these (7 schools, 1015 children). Parents of 36/1015 (3.5%) children opted out. Baseline data were collected from teachers for 94% children, and 91% children completed self-report questionnaires; parent-report questionnaires were returned for 19% of children. During the exceptional circumstance of the COVID pandemic, two schools left the study, and many children were not attending school, meaning follow-up data were received from 32% of children, 16% of teachers and 14% of parents. Interview data indicated that the intervention was acceptable, and teachers would have preferred on-site eye tests to the offer of a clinic appointment and a clear timetable for study events. Teachers in intervention schools reported expected changes in the children's and their own behaviour. There was some contamination between study arms. CONCLUSIONS: A full-scale trial would be feasible, enhanced by insights from this feasibility trial, in non-pandemic times. Sharing these data with teachers, education policymakers and parents is planned to refine the design. TRIAL REGISTRATION: ISRCTN13762177.