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针对自闭症成年患者的自我伤害和自杀行为的适应性安全计划:单臂可行性试验和外部试点随机对照试验

Adapted Safety Plans to Address Self-Harm and Suicide Behaviours in Autistic Adults: single arm feasibility trial and external pilot RCT.

作者信息

Rodgers Jacqui, Bhattarai Nawaraj, Goodwin Jane, Gordon Isabel, Heslop Phil, Nielsen Emma, O'Connor Rory Ciaran, Ogundimu Emmanuel, Pelton Mirabel, Ramsay Sheena, Townsend Ellen, Vale Luke, Wagnild Janelle, Wilson Colin, Cassidy Sarah

机构信息

Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.

Health Economics Group, Population Health Science Institute, Newcastle University, Newcastle upon Tyne, UK.

出版信息

Public Health Res (Southampt). 2025 Nov;13(10):1-19. doi: 10.3310/CGDF8525.

DOI:10.3310/CGDF8525
PMID:41273209
Abstract

BACKGROUND

Suicide prevention is a national priority for United Kingdom government policy, and autistic people have recently been identified as a high-risk group in both the Department of Health and Social Care suicide prevention strategy and National Institute for Health and Care Excellence suicide prevention guidelines. No suicide prevention interventions have been developed specifically for autistic people. Safety plans are a simple, cost-effective, potentially life-saving intervention.

AIMS

To evaluate the feasibility and acceptability of the use of Autism Adapted Safety Plans for autistic adults and to undertake an external pilot to explore whether a larger future definitive trial is achievable.

METHODS

Stage 1 involved focus groups with autistic adults ( = 15), family members ( = 5) and service providers ( = 10) to inform adaptations to the Autism Adapted Safety Plans. Stage 2 was an interventional single-arm feasibility trial where autistic adults ( = 8) completed an Autism Adapted Safety Plans with a supporter ( = 8). Data on recruitment, completion of study measures and participant feedback informed final adaptations to the Autism Adapted Safety Plans and research methods prior to stage 3. Stage 3 was a pilot feasibility randomised controlled trial of Autism Adapted Safety Plans. Autistic adults were recruited via non-National Health Service organisations and self-referral. Participants were randomised without stratification to usual care ± Autism Adapted Safety Plans. The Autism Adapted Safety Plan was completed by the autistic adults with someone trained to support them. Research staff completing follow-up assessments were blind to participant allocation. Primary outcomes were feasibility and acceptability of the Autism Adapted Safety Plans to inform the parameters of a definitive randomised controlled trial. Participants were assessed at baseline, 1 and 6 months.

RESULTS

Stage 1 and 2 interviews highlighted the conditions needed to make the process of creating the Autism Adapted Safety Plans acceptable for autistic adults. Stage 2 also informed modifications to recruitment (to include self-referral) in stage 3. In stage 3, 53 participants consented, 49 were randomised to either Autism Adapted Safety Plans + usual care ( = 25) or usual care ( = 24). Sixty-eight per cent of participants were satisfied with the Autism Adapted Safety Plans and 41% rated it as usable. Feedback on the Autism Adapted Safety Plans and study processes employed in the trial were positive with suggested minor adaptations to some outcome measures. Retention of those randomised was 95% at 6-month follow-up. Completion rates for outcome measures were generally high (> 85%). Fidelity ratings for delivery of the Autism Adapted Safety Plans were 94% for therapeutic components and 91% for adherence to content.

CONCLUSION

Autism Adapted Safety Plans are a potentially valuable intervention for autistic adults, provided that the process of creating it is flexible and sensitive to individual needs. The parameters of a future definitive trial of the clinical and cost-effectiveness of Autism Adapted Safety Plans are achievable, with minor recommended adaptations. Further testing of the Autism Adapted Safety Plans to assess its clinical and cost-effectiveness in National Health Service clinical services is urgently needed.

LIMITATIONS

The sample size was below the initially intended sample of 70 participants due to difficulties with recruitment during the COVID-19 pandemic. As autistic participants self-referred into the study, data are not available regarding how many participants were approached to take part in the study. The majority of the study sample was White.

FUTURE WORK

A full definitive trial testing the clinical and cost-effectiveness of Autism Adapted Safety Plans in National Health Service clinical services is warranted. This fully powered trial will need to recruit a more diverse sample than was possible in the pilot trial. Results suggest that minor adaptations to the Autism Adapted Safety Plans could make this more personalised and accessible, such as through an app or website.

FUNDING

This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR129196.

摘要

背景

预防自杀是英国政府政策的国家优先事项,在卫生和社会保健部的自杀预防战略以及国家卫生与保健卓越研究所的自杀预防指南中,自闭症患者最近都被确定为高危群体。尚未专门为自闭症患者制定自杀预防干预措施。安全计划是一种简单、具有成本效益且可能挽救生命的干预措施。

目的

评估为成年自闭症患者使用自闭症适应安全计划的可行性和可接受性,并进行外部试点,以探索未来是否能够开展更大规模的确定性试验。

方法

第一阶段涉及与成年自闭症患者(n = 15)、家庭成员(n = 5)和服务提供者(n = 10)进行焦点小组讨论,以为自闭症适应安全计划的调整提供参考。第二阶段是一项干预性单臂可行性试验,成年自闭症患者(n = 8)在支持者(n = 8)的帮助下完成一份自闭症适应安全计划。关于招募、研究措施的完成情况以及参与者反馈的数据,为第三阶段之前对自闭症适应安全计划和研究方法的最终调整提供了依据。第三阶段是自闭症适应安全计划的试点可行性随机对照试验。成年自闭症患者通过非国民医疗服务体系组织和自我推荐招募。参与者未分层随机分配至常规护理±自闭症适应安全计划组。自闭症适应安全计划由成年自闭症患者在经过培训以提供支持的人员协助下完成。进行随访评估的研究人员对参与者的分配情况不知情。主要结局是自闭症适应安全计划的可行性和可接受性,以为确定性随机对照试验的参数提供参考。在基线、1个月和6个月时对参与者进行评估。

结果

第一阶段和第二阶段的访谈突出了使创建自闭症适应安全计划的过程为成年自闭症患者所接受所需的条件。第二阶段还为第三阶段的招募方式调整(包括自我推荐)提供了参考。在第三阶段,53名参与者表示同意,49名被随机分配至自闭症适应安全计划 + 常规护理组(n = 25)或常规护理组(n = 24)。68%的参与者对自闭症适应安全计划感到满意,41%的参与者认为其可用。对自闭症适应安全计划和试验中采用的研究过程的反馈是积极的,建议对一些结局指标进行轻微调整。在6个月随访时,随机分组参与者的留存率为95%。结局指标的完成率总体较高(> 85%)。自闭症适应安全计划实施的保真度评级为:治疗成分94%,内容依从性91%。

结论

自闭症适应安全计划对成年自闭症患者可能是一项有价值的干预措施,前提是创建过程灵活且能满足个体需求。未来对自闭症适应安全计划的临床和成本效益进行确定性试验的参数是可以实现的,建议进行一些小的调整。迫切需要在国民医疗服务体系临床服务中对自闭症适应安全计划进行进一步测试,以评估其临床和成本效益。

局限性

由于在新冠疫情期间招募困难,样本量低于最初计划的70名参与者的样本。由于自闭症参与者是自我推荐参与研究,因此没有关于有多少人被邀请参与研究的数据。研究样本大多数是白人。

未来工作

有必要在国民医疗服务体系临床服务中进行一项全面的确定性试验,以测试自闭症适应安全计划的临床和成本效益。这项充分有力的试验需要招募比试点试验更具多样性的样本。结果表明,对自闭症适应安全计划进行一些小的调整可以使其更具个性化和可及性,例如通过应用程序或网站。

资金

本摘要介绍了由国家卫生与保健研究机构(NIHR)公共卫生研究项目资助的独立研究,资助编号为NIHR129196。

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