Rodgers Jacqui, Cassidy Sarah, Pelton Mirabel, Goodwin Jane, Wagnild Janelle, Bhattarai Nawaraj, Gordon Isabel, Wilson Colin, Heslop Phil, Ogundimu Emmanuel, O'Connor Rory C, Ramsay Sheena E, Townsend Ellen, Vale Luke
Population Health Sciences Institute, Newcastle University, NE1 7RU, UK.
School of Psychology, University of Nottingham, NG7 2RD, UK.
EClinicalMedicine. 2024 Jun 1;73:102662. doi: 10.1016/j.eclinm.2024.102662. eCollection 2024 Jul.
Autistic people are a high-risk group for self-harm and suicide. There are no evidence-based suicide prevention interventions developed specifically for autistic people. We undertook a pilot feasibility randomised controlled trial of autism adapted safety plans (AASP) to reduce self-harm and suicide for autistic people.
This study took place in the United Kingdom and followed a randomised, two-arm, controlled design. Autistic adults (n = 53, mean age = 39, gender = 49% female, 29% not male or female) were recruited via third sector organisations and self-referral between 11.8.21 and 19.10.22. Participants were randomised without stratification to usual care with or without AASP. The AASP was completed by the autistic adults together with someone trained to support them. Research staff who completed follow-up assessments were blind to participant allocation. Primary outcomes were feasibility and acceptability. Participants were assessed at baseline, 1 and 6 months. Primary data were analysed under the intention to treat principle. Study protocol is published. The trial is closed to new participants. This study is registered with the ISRCTN registry, ISRCTN70594445.
53 participants consented, 49 were randomised to either AASP with usual care (n = 25) or usual care (n = 24). 68% of participants in the AASP arm were satisfied with the AASP and 41% rated it as useable. Feedback on the AASP and research methods were positive with suggested adaptations to some outcome measures. Retention and completion of outcomes measures in both arms was excellent, as was fidelity of delivery of the AASP.
Study progression criteria were met, suggesting that the parameters of a future definitive trial of clinical and cost effectiveness of AASP to reduce self-harm and suicide in autistic adults are achievable, with minor recommended adaptions to outcome measures and AASP. Future research should explore the use of AASP in routine clinical practice.
This study is funded by the NIHR [Public Health Research Programme (NIHR129196)].
自闭症患者是自伤和自杀的高危群体。目前尚无专门为自闭症患者制定的基于证据的自杀预防干预措施。我们开展了一项针对自闭症适应性安全计划（AASP）的试点可行性随机对照试验，以减少自闭症患者的自伤和自杀行为。
本研究在英国进行，采用随机、双臂、对照设计。通过第三部门组织和自我推荐，在2021年8月11日至2022年10月19日期间招募了成年自闭症患者（n = 53，平均年龄 = 39岁，49%为女性，29%非男非女）。参与者未分层随机分为接受或不接受AASP的常规护理组。AASP由成年自闭症患者与接受过支持他们培训的人员共同完成。完成随访评估的研究人员对参与者的分组情况不知情。主要结局指标为可行性和可接受性。在基线、1个月和6个月时对参与者进行评估。主要数据按照意向性分析原则进行分析。研究方案已发表。该试验不再招募新参与者。本研究已在国际标准随机对照试验编号注册中心注册，注册号为ISRCTN70594445。
53名参与者同意参与研究，49名被随机分为接受AASP联合常规护理组（n = 25）或常规护理组（n = 24）。AASP组中68%的参与者对AASP感到满意，41%的参与者认为其可用。对AASP和研究方法的反馈是积极的，并建议对一些结局指标进行调整。两组结局指标的保留率和完成率都很高，AASP的实施保真度也很高。
达到了研究进展标准，这表明未来对AASP减少成年自闭症患者自伤和自杀的临床及成本效益进行确定性试验的参数是可以实现的，只需对结局指标和AASP进行少量推荐的调整。未来的研究应探索AASP在常规临床实践中的应用。
本研究由英国国家卫生研究院[公共卫生研究项目（NIHR项目编号129196）]资助。
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