以学校为基础的干预改善脑视觉障碍儿童心理健康结局:可行性聚类随机试验

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Cathy Williams, Anna Pease, Trudy Goodenough, Katie Breheny, Beverly Shirkey, Rose Watanabe, Parisa Sinai, Manmita Rai, Innes C Cuthill, Mark Mumme, Andrew W Boyd, Cassandra Wye, Chris Metcalfe, Daisy Gaunt, Kate Barnes, Siobhan Rattigan, Stephanie West, John Ferris, Jay Self
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引用次数: 0

摘要

背景:脑视觉障碍(CVI)是指与大脑相关的视觉困难,通常未被诊断并可能导致不良的心理健康结果。我们已经制定了一项干预措施,以改善受影响儿童的心理健康结果,但需要对其进行评估。本研究的目的是评估为未来确定的聚类随机试验提出的方法的可行性。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,其中包括因COVID大流行而暂停的6个月。参与者是主流小学7-10岁的儿童及其老师和家长。我们代表他们学校聘请了校长。干预措施是为教师提供资源包,解释CVI,提供普遍和有针对性的策略来帮助患有CVI的儿童,并在当地眼科诊所提供CVI评估。对照学校继续进行常规训练。我们的目的是评估招募和数据收集的可行性、减员、研究方法的可接受性和干预措施的实施。我们进行了包括访谈和问卷调查在内的过程评估。结果:我们向297所学校发出邀请函,收到回复6%,并招募了其中的40%(7所学校,1015名儿童)。1015名儿童中有36名(3.5%)的家长选择退出。94%的儿童从教师处收集基线数据,91%的儿童完成了自我报告问卷;19%的孩子返回了父母报告问卷。在新冠肺炎大流行的特殊情况下,两所学校退出了研究,许多儿童没有上学,这意味着从32%的儿童、16%的教师和14%的家长那里收到了后续数据。访谈数据表明,干预是可以接受的,教师更愿意接受现场视力检查,而不是提供诊所预约和明确的学习活动时间表。干预学校的老师报告了孩子们和他们自己行为的预期变化。研究组之间存在一些污染。结论:在非大流行时期,全面试验将是可行的,从这项可行性试验中获得的见解将得到加强。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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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

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

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

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.

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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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