Adapted safety plans to address self-harm and suicide behaviours in autistic adults : single arm feasibility trial and external pilot RCT

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 (n = 15), family members (n = 5) and service providers (n = 10) to inform adaptations to the Autism Adapted Safety Plans. Stage 2 was an interventional single-arm feasibility trial where autistic adults (n = 8) completed an Autism Adapted Safety Plans with a supporter (n = 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 (n = 25) or usual care (n = 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.