F Christie-de Jong, E Walker, H Corlett, C Hardarce, E Soulsby, B Arnott, K Franks, J Ling, J Stephenson, L B Azevedo
{"title":"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。","authors":"F Christie-de Jong, E Walker, H Corlett, C Hardarce, E Soulsby, B Arnott, K Franks, J Ling, J Stephenson, L B Azevedo","doi":"10.1186/s40814-025-01699-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT06807931. Retrospectively registered 04 February 2025 https://clinicaltrials.gov/study/NCT06807931 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"117"},"PeriodicalIF":1.6000,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406547/pdf/","citationCount":"0","resultStr":"{\"title\":\"A cluster randomised feasibility trial assessing an interactive film intervention to improve wellbeing of young people in school settings in the North of England.\",\"authors\":\"F Christie-de Jong, E Walker, H Corlett, C Hardarce, E Soulsby, B Arnott, K Franks, J Ling, J Stephenson, L B Azevedo\",\"doi\":\"10.1186/s40814-025-01699-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT06807931. 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A cluster randomised feasibility trial assessing an interactive film intervention to improve wellbeing of young people in school settings in the North of England.
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.
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.