A cluster randomised feasibility trial assessing an interactive film intervention to improve wellbeing of young people in school settings in the North of England.

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
F Christie-de Jong, E Walker, H Corlett, C Hardarce, E Soulsby, B Arnott, K Franks, J Ling, J Stephenson, L B Azevedo
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引用次数: 0

Abstract

Background: Adolescence is a critical period for the onset of mental illness. A partnership of a health and care network and filmmakers developed an interactive film for youth wellbeing. While such films have potential as a cost-effective preventative tool, their effectiveness remains unproven. This study aimed to assess the feasibility and acceptability of a randomised controlled trial of the interactive film intervention to improve wellbeing in school-aged youth.

Methods: In a mixed-methods cluster randomised feasibility trial in North East England (2021-2022), students in years 10 (14-15 years) and 12 (16-17 years) from three schools were recruited and randomised to the following conditions: (1) watching the film in class, (2) watching the film in class with support from youth workers or (3) regular class activities. Feasibility outcomes included willingness of schools to participate, participant recruitment, and retention, which were assessed quantitatively and qualitatively. Data were analysed descriptively and with the use of thematic analysis.

Results: School recruitment targets were met, although this was challenging due to resource constraints and the COVID-19 pandemic. Questionnaires were completed before watching the film by 172 students (48% of the recruitment target). Follow-up targets for retention were met at 3 months (n = 138) and 6 months (n = 136). Retention of year 10 students was high (96%), but year 12 students had lower retention (60%). Qualitative findings showed students and teachers supported the intervention and trial and measurements; however, consent-taking required more time. Communication and resource issues within schools were challenging and need addressing before moving to a larger trial.

Conclusion: Although some trial aspects were feasible and acceptable, particularly the intervention, others, such as recruitment, retention and school communication, posed challenges. We recommend future feasibility studies should address barriers such as randomisation, communication with schools, recruitment of older students (16-18 years), consent and measurement alignment before moving to a larger-scale trial.

Trial registration: ClinicalTrials.gov Identifier: NCT06807931. Retrospectively registered 04 February 2025 https://clinicaltrials.gov/study/NCT06807931 .

Abstract Image

一项集群随机可行性试验评估互动电影干预,以改善英格兰北部学校环境中年轻人的福祉。
背景:青春期是精神疾病发病的关键时期。一个卫生保健网络和电影制作人合作制作了一部关于青年福祉的互动电影。虽然这种薄膜有可能成为具有成本效益的预防工具,但其有效性尚未得到证实。本研究旨在评估互动电影干预改善学龄青少年幸福感的随机对照试验的可行性和可接受性。方法:在英格兰东北部(2021-2022)进行的混合方法整群随机可行性试验中,从三所学校招募了10年级(14-15岁)和12年级(16-17岁)的学生,并随机分配到以下条件:(1)在课堂上观看电影,(2)在青年工作者的支持下在课堂上观看电影,或(3)定期参加课堂活动。可行性结果包括学校参与的意愿、参与者的招募和保留,并对这些结果进行了定量和定性评估。对数据进行了描述性和专题分析。结果:学校实现了招生目标,尽管由于资源限制和COVID-19大流行,这一目标具有挑战性。172名学生(占招聘目标的48%)在观看电影前完成了问卷调查。随访3个月(n = 138)和6个月(n = 136)时均达到保留率指标。10年级学生的保留率很高(96%),但12年级学生的保留率较低(60%)。定性调查结果显示,学生和教师支持干预、试验和测量;然而,征得同意需要更多的时间。学校内部的沟通和资源问题具有挑战性,需要在进行更大规模的试验之前解决。结论:虽然试点的一些方面是可行和可接受的,特别是干预措施,但其他方面,如招生、留用和学校沟通,存在挑战。我们建议未来的可行性研究应解决诸如随机化、与学校沟通、招募年龄较大的学生(16-18岁)、同意和测量校准等障碍,然后再进行更大规模的试验。试验注册:ClinicalTrials.gov标识符:NCT06807931。追溯注册于2025年2月4日https://clinicaltrials.gov/study/NCT06807931。
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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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