Molehill Mountain feasibility study: Protocol for a non-randomised pilot trial of a novel app-based anxiety intervention for autistic people.

Up to 50% of autistic people experience co-occurring anxiety, which significantly impacts their quality of life. Consequently, developing new interventions (and/ or adapting existing ones) that improve anxiety has been indicated as a priority for clinical research and practice by the autistic community. Despite this, there are very few effective, evidence-based therapies available to autistic people that target anxiety; and those that are available (e.g., autism adapted Cognitive Behavioural Therapy; CBT) can be challenging to access. Thus, the current study will provide an early-stage proof of concept for the feasibility and acceptability of a novel app-based therapeutic approach that has been developed with, and adapted for, autistic people to support them in managing anxiety using UK National Institute for Health and Care Excellence (NICE) recommended adapted CBT approaches. This paper describes the design and methodology of an ethically approved (22/LO/0291) ongoing non-randomised pilot trial that aims to enrol approximately 100 participants aged ≥16-years with an existing autism diagnosis and mild-to-severe self-reported anxiety symptoms (trial registration NCT05302167). Participants will be invited to engage with a self-guided app-based intervention-'Molehill Mountain'. Primary (Generalised Anxiety Disorder Assessment, Hospital Anxiety and Depression Scale) and secondary outcomes (medication/ service use and Goal Attainment Scaling) will be assessed at baseline (Week 2 +/- 2), endpoint (Week 15 +/- 2) and three follow-ups (Weeks 24, 32 and 41 +/- 4). Participants will also be invited to complete an app acceptability survey/ interview at the study endpoint. Analyses will address: 1) app acceptability/ useability and feasibility (via survey/ interview and app usage data); and 2) target population, performance of outcome measures and ideal timing/ duration of intervention (via primary/ secondary outcome measures and survey/ interview)-with both objectives further informed by a dedicated stakeholder advisory group. The evidence from this study will inform the future optimisation and implementation of Molehill Mountain in a randomised-controlled trial, to provide a novel tool that can be accessed easily by autistic adults and may improve mental health outcomes.

Violent experiences and neighbourhoods during adolescence: understanding and mitigating the association with mental health at the transition to adulthood in a longitudinal cohort study.

PURPOSE: Violence occurs at multiple ecological levels and can harm mental health. However, studies of adolescents' experience of violence have often ignored the community context of violence, and vice versa. We examined how personal experience of severe physical violence and living in areas with high levels of neighbourhood disorder during adolescence combine to associate with mental health at the transition to adulthood and which factors mitigate this. METHOD: Data were from the Environmental Risk Longitudinal Twin Study, a nationally representative birth cohort of 2232 British twins. Participants' experience of severe physical violence during adolescence and past-year symptoms of psychiatric disorder were assessed via interviews at age 18. Neighbourhood disorder was reported by residents when participants were aged 13-14. Potential protective factors of maternal warmth, sibling warmth, IQ, and family socio-economic status were assessed during childhood, and perceived social support at age 18. RESULTS: Personal experience of severe physical violence during adolescence was associated with elevated odds of age-18 psychiatric disorder regardless of neighbourhood disorder exposure. Cumulative effects of exposure to both were evident for internalising and thought disorder, but not externalising disorder. For adolescents exposed to severe physical violence only, higher levels of perceived social support (including from family and friends) were associated with lower odds of psychiatric disorder. For those who also lived in areas with high neighbourhood disorder, only family support mitigated their risk. CONCLUSION: Increasing support or boosting adolescents' perceptions of their existing support network may be effective in promoting their mental health following violence exposure.