A digital intervention to improve mental health and interpersonal resilience for young people who have experienced online sexual abuse: the i-Minds non-randomised feasibility clinical trial and nested qualitative study.

Sandra Bucci, Filippo Varese, Ethel Quayle, Kim Cartwright, Amanda Larkin, Cindy Chan, Prathiba Chitsabesan, Victoria Green, William Hewins, Matthew Machin, Alice Newton, Erica Niebauer, John Norrie, Gillian Radford, Cathy Richards, Marina Sandys, Victoria Selby, Sara Shafi, Jennifer Ward, Pauline Whelan, Matthias Schwannauer
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Recommendations from our pre-trial qualitative work with healthcare professionals supporting young people with technology-assisted sexual abuse and lived experience consultation informed app development and trial procedures. The primary outcome was the feasibility and acceptability of delivering the digital intervention measured against relevant fields of the Consolidated Standards of Reporting Trials statement for feasibility studies. Intervention safety was reported against an adverse events procedure. Usability was guided by the framework for analysing and measuring usage and engagement data in digital interventions. Acceptability was examined using qualitative methods. The planned sample size of the feasibility clinical trial was 60 young people.</p><p><strong>Results: </strong>Between May 2022 and March 2023, 147 young people were screened for eligibility for the feasibility clinical trial; 72 referrals were made and 43 young people were allocated to receive the intervention. 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引用次数: 0

Abstract

Background: No evidence-based support for young people who have experienced technology-assisted sexual abuse exists. The project's aims were to develop a digital intervention that improves mentalisation (the ability to understand the minds of oneself and others that underlies behaviour) to reduce the risk for revictimisation and future harm and improve young people's resilience.

Objectives: To co-design a mentalisation-based digital intervention; determine its feasibility, acceptability, safety and usability; and determine how to best integrate this into practice.

Methods: A mixed-methods, non-randomised study in young people aged 12-18 years exposed to technology-assisted sexual abuse across two United Kingdom sites. We adapted an existing mentalisation-based therapy manual and co-designed a digital health intervention (app) using participatory methods. Recommendations from our pre-trial qualitative work with healthcare professionals supporting young people with technology-assisted sexual abuse and lived experience consultation informed app development and trial procedures. The primary outcome was the feasibility and acceptability of delivering the digital intervention measured against relevant fields of the Consolidated Standards of Reporting Trials statement for feasibility studies. Intervention safety was reported against an adverse events procedure. Usability was guided by the framework for analysing and measuring usage and engagement data in digital interventions. Acceptability was examined using qualitative methods. The planned sample size of the feasibility clinical trial was 60 young people.

Results: Between May 2022 and March 2023, 147 young people were screened for eligibility for the feasibility clinical trial; 72 referrals were made and 43 young people were allocated to receive the intervention. We found that it was possible to recruit and retain participants to this trial. Quantitative and qualitative data showed that the i-Minds app was safe, acceptable and associated with promising signals of efficacy on valuable outcomes post treatment, including technology-assisted-sexual-abuse-related post-traumatic symptoms, resilience, internalising symptoms and reflective functioning. Most participants accessed or completed app modules. User feedback indicated that participants had a positive experience using the app, positively increasing their knowledge/understanding of their own mental health and their motivation to address their mental health difficulties. Practitioners identified the barriers to implementing i-Minds into routine practice as not being involved in its design at the outset, possible impact on workload and whether digital health interventions might replace routine care. Facilitators included the distinct nature and specificity of the i-Minds app for the target group and its ability to support young people on service waiting lists.

Limitations: There was limited ethnic diversity in the samples, reflecting potential selection bias at the referral point. Sexual orientation is not reported in the trial. The trial lacked randomisation and a control group, limiting interpretation of post-treatment improvements.

Conclusions: A mentalisation-based digital intervention is feasible, acceptable and safe. A larger-scale evaluation appears warranted. Further service improvements are required for routine assessment and support for young people experiencing technology-assisted sexual abuse.

Future work: Further questions could be explored, including evaluating training materials for online harms, developing guidelines assessing for and responding to online harms, validated measures to assess for online harms, understanding further where digital health interventions fit along the clinical care pathway, recruiting a more diverse sample, and further differentiating the forms of online harms and their consequences.

Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number NIHR131848.

数字干预改善经历过网络性虐待的年轻人的心理健康和人际恢复能力:i-Minds非随机可行性临床试验和嵌套定性研究。
背景:对于经历过技术辅助性侵犯的年轻人,没有证据支持。该项目的目标是开发一种数字干预手段,提高心理化(理解自己和他人行为背后的心理的能力),以减少再次受害和未来伤害的风险,提高年轻人的适应能力。目的:共同设计一种基于心理的数字干预;确定其可行性、可接受性、安全性和可用性;并确定如何最好地将其整合到实践中。方法:一项混合方法,非随机研究,在英国两个地点的12-18岁暴露于技术辅助性虐待的年轻人中进行。我们改编了现有的基于心理的治疗手册,并使用参与式方法共同设计了数字健康干预(app)。我们与医疗保健专业人员进行的试验前定性工作提出的建议为应用程序开发和试验程序提供了信息,这些建议支持技术辅助性虐待和生活经验咨询的年轻人。主要结果是提供数字干预的可行性和可接受性,根据可行性研究报告试验综合标准声明的相关领域进行衡量。对不良事件程序的干预安全性进行了报告。可用性以分析和衡量数字干预中的使用和参与数据的框架为指导。采用定性方法检验可接受性。可行性临床试验的计划样本量为60名年轻人。结果:2022年5月至2023年3月期间,147名年轻人被筛选为可行性临床试验的资格;共转介72人,43名年轻人获分配接受干预。我们发现招募并留住参与者是可能的。定量和定性数据表明,i-Minds应用程序是安全的、可接受的,并且在治疗后的有价值的结果方面,包括技术辅助性虐待相关的创伤后症状、复原力、内化症状和反思功能,与有希望的疗效信号相关。大多数参与者访问或完成了应用程序模块。用户反馈表明,参与者在使用该应用程序时获得了积极的体验,积极地增加了他们对自己心理健康的认识/理解,以及他们解决心理健康问题的动力。从业人员指出,在日常实践中实施i-Minds的障碍包括:一开始就没有参与其设计,可能对工作量产生影响,以及数字健康干预措施是否可能取代常规护理。促成因素包括i-Minds应用程序针对目标群体的独特性质和特殊性,以及它为服务等候名单上的年轻人提供支持的能力。局限性:样本中的种族多样性有限,反映了在转诊点潜在的选择偏差。性取向在试验中没有被提及。该试验缺乏随机化和对照组,限制了对治疗后改善的解释。结论:基于心理状态的数字化干预是可行、可接受和安全的。看来有必要进行更大规模的评估。需要进一步改善服务,对遭受技术辅助性虐待的年轻人进行例行评估和提供支持。未来的工作:可以探索更多的问题,包括评估在线危害的培训材料,制定评估和应对在线危害的指南,验证评估在线危害的措施,进一步了解数字健康干预措施在临床护理途径中的适用范围,招募更多样化的样本,并进一步区分在线危害的形式及其后果。资助:本摘要介绍了由国家卫生和保健研究所(NIHR)卫生和社会保健提供研究计划资助的独立研究,奖励号为NIHR131848。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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