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一项基于学校的干预措施,旨在改善患有脑性视觉障碍(CVI)儿童的心理健康状况:可行性整群随机试验。

A school-based intervention to improve mental health outcomes for children with cerebral visual impairment (CVI): feasibility cluster randomised trial.

作者信息

Williams Cathy, Pease Anna, Goodenough Trudy, Breheny Katie, Shirkey Beverly, Watanabe Rose, Sinai Parisa, Rai Manmita, Cuthill Innes C, Mumme Mark, Boyd Andrew W, Wye Cassandra, Metcalfe Chris, Gaunt Daisy, Barnes Kate, Rattigan Siobhan, West Stephanie, Ferris John, Self Jay

机构信息

Bristol Medical School, University of Bristol, Bristol, UK.

Department of Health Economics, University of Bristol, Bristol, UK.

出版信息

Pilot Feasibility Stud. 2025 Mar 3;11(1):24. doi: 10.1186/s40814-025-01603-x.

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.

摘要

背景

脑性视觉障碍(CVI)是指与大脑相关的视力问题,这些问题常常未被诊断出来,可能会导致不良的心理健康结果。我们开发了一种干预措施来改善受影响儿童的心理健康状况,需要对其进行评估。本研究的目的是评估为未来确定性整群随机试验所提议方法的可行性。

方法

这项为期18个月的研究于2019年至2021年在英国英格兰西南部进行,由于新冠疫情有6个月的暂停期。参与者是主流小学中7至10岁的儿童及其教师和家长。我们代表学校招募校长。干预措施是为教师提供一个资源包,内容包括关于CVI的讲解、帮助CVI儿童的通用和针对性策略,以及在当地眼科诊所提供CVI评估。对照学校继续照常开展工作。我们的目标是评估招募和数据收集、人员流失、研究方法的可接受性以及干预措施实施的可行性。我们进行了一项包括访谈和问卷调查的过程评估。

结果

我们向297所学校发送了邀请信,收到6%的回复,其中40%(7所学校,1015名儿童)被招募。1015名儿童中的36名(3.5%)家长选择退出。94%的儿童的教师收集了基线数据,91%的儿童完成了自我报告问卷;19%的儿童返回了家长报告问卷。在新冠疫情的特殊情况下,两所学校退出了研究,许多儿童未上学,这意味着32%的儿童、16%的教师和14%的家长的随访数据被收到。访谈数据表明该干预措施是可接受 的,并且教师们更希望进行现场眼科检查而不是提供诊所预约,以及有一个明确的研究活动时间表。干预学校的教师报告了儿童及其自身行为的预期变化。研究组之间存在一些交叉影响。

结论

在非疫情时期,在本次可行性试验的见解的助力下,进行全面试验将是可行的。计划与教师、教育政策制定者和家长分享这些数据以完善设计。

试验注册

ISRCTN13762177

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/58b9/11874832/8a3c11cd89bd/40814_2025_1603_Fig1_HTML.jpg

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