The lived experiences of relatives of autistic adults, and their perceptions of their relationships with autistic adults across multiple age-related transitions and demands: A qualitative interview study with reflexive thematic analysis.

BACKGROUND: There is a need to better understand autism across the life course, including the lives of both autistic people and supporting relatives. As part of a larger mixed methods cohort study involving autistic adults, carers and relatives this sub-study focused on the experiences of relatives alone to learn more about the lives of people from the wider personal networks. Our research questions were: 1. What are the experiences of family members who care for and/or support autistic adults, 2. How can the viewpoints of relatives add to what we know about transitions and challenges experienced by autistic adults, and 3. What strategies/support have been helpful for adults and relatives? METHODS: Relatives of autistic adults were purposively sampled and recruited using the Relatives/Carers cohort from the Adult Autism Spectrum Cohort-UK. 18 participants aged 31-81years who were related to 16 autistic adults aged 18-57years were interviewed for 24-91minutes. Interview transcripts were examined using reflexive thematic analysis. MAIN FINDINGS: Two overarching themes were developed, 'Family support goes a long way in caring for autistic adults' and 'When families turn to society for support' with subthemes. Relatives described benefits they had gained and their admiration for autistic adults. They reflected on how they gave support for independence in various contexts of dependence. They also identified the challenges that both autistic adults and families face navigating support systems (for example for healthcare and employment). An important novel outcome was the advocated value of role-models with lived experience who come from outside of the family. RECOMMENDATIONS: The findings lead to recommendations for: (i) Strategies to reduce the barriers for support that are faced by autistic individuals and relatives during crisis points; (ii) recognition and support for what enables both relatives and autistic adults to function independently (e.g. funded activities, flexible employment); (iii) future planning conversations to include relatives who can enhance knowledge and help plan for future care or support needs for autistic adults and (iv) opportunities for role models (persons with lived experience, autistic adults and relatives) to inspire others and disseminate knowledge. CONCLUSIONS: These findings add valuable insights into the experiences of relatives of autistic adults and challenge the reader to have greater appreciation of the many roles relatives can contribute across time and in a variety of contexts. These perspectives add important information for those working with and planning provision for autistic adults.

A Pilot Randomised Control Trial Exploring the Feasibility and Acceptability of Delivering a Personalised Modular Psychological Intervention for Anxiety Experienced by Autistic Adults: Personalised Anxiety Treatment-Autism (PAT-A).

Anxiety is commonly experienced by autistic people and impacts on quality of life and social participation. New anxiety interventions are required to effectively meet the needs of autistic people. Personalised Anxiety Treatment-Autism (PAT-A©) is a bespoke, modular approach to treating anxiety in up to 12 sessions. This study explored the feasibility and acceptability of delivering PAT-A© in the UK National Health Service (NHS). A single-blind randomised controlled trial design. Thirty-four autistic adults were recruited via clinical services and randomised to receive either PAT-A© or enhanced treatment as usual (CCSP). Outcome assessments relating to anxiety, quality of life and related constructs were completed at baseline, immediately post intervention; and at 3 and 12 months. Seventy-one percent of the PAT-A© group and 65% of the CCSP met diagnostic threshold for at least three anxiety disorders. Retention was good across both groups, with 82% (N = 14/17) completing the full course of PAT-A© and 71% (N = 12/17) attending both psychoeducational sessions in CCSP. 94% in PAT-A© and 82% in CCSP completed some follow up assessment 3 months post-intervention. Thematic analysis of interview data revealed that many participants valued the personalised approach, developed transferable skills and experienced positive changes to their anxiety. Participants were willing to be recruited and randomised, PAT-A© was feasible to deliver in the NHS and the trial methods and materials were acceptable. Our findings indicate that a fully powered clinical and cost-effectiveness trial of PAT-A© is warranted.

Impacts of health care service changes implemented due to COVID-19 on children and young people with long-term disability: A mapping review.

AIM: To identify the research on childhood disability service adaptations and their impact on children and young people with long-term disability during the COVID-19 pandemic. METHOD: A mapping review was undertaken. We searched the World Health Organization Global COVID-19 database using the search terms 'children', 'chronic/disabling conditions', and 'services/therapies'. Eligible papers reported service changes for children (0-19 years) with long-term disability in any geographical or clinical setting between 1st January 2020 and 26th January 2022. Papers were charted across the effective practice and organization of care taxonomy of health system interventions and were narratively synthesized; an interactive map was produced. RESULTS: Reduction of face-to-face care and usual provision had a huge impact on children and families. Adoption of telehealth provided continuity for the care and management of some conditions. There was limited evidence of changes to mental health services, transitions of care, social care, or child-reported satisfaction or acceptability of service changes. INTERPRETATION: The long-term impacts of service change during the pandemic need full evaluation. However, widespread disruption seems to have had a profound impact on child and carer health and well-being. Service recovery needs to be specific to the individual needs of children with a disability and their families. This should be done through coproduction to ensure that service changes meet needs and are accessible and equitable.

Co-design of an NHS primary care health check for autistic adults.

LAY ABSTRACT: Autistic people are on average more likely to experience poor health than people who are not autistic. Health checks have been shown to improve access to effective healthcare. This study investigated people's views about a primary care health check for autistic adults. We held discussion groups and interviewed autistic adults, adults with intellectual disabilities, supporters and health professionals. People wanted the health check to look at a person's physical and mental health, and how they were doing socially. They thought people should be able to share information about their needs and the reasonable adjustments they would like before the health check. They wanted healthcare services to change the way they communicate with autistic people, such as being able to book appointments online rather than by telephone. They wanted a choice in how the health check was completed, with video call or email offered as well as face-to-face appointments. People thought further training of primary care staff on autism was needed, to increase awareness of the diversity of experiences of autistic people and ways in which difficulties, such as pain, may present differently to non-autistic people. Clinicians raised questions about whether mental health and social care services could meet the additional needs that might be identified through the health check. We used this information to design an NHS primary care health check for autistic people in collaboration with autistic people, supporters and health professionals.

Coping with uncertainty in everyday situations (CUES©) to address intolerance of uncertainty in autistic children: an intervention feasibility trial.

BACKGROUND: Anxiety related to uncertainty is common in autism. Coping with Uncertainty in Everyday Situations (CUES©) is a parent-mediated group intervention aiming to increase autistic children's tolerance to uncertain situations. A pilot study was conducted to test its feasibility and acceptability. METHODS: Parents of 50 autistic children were randomised to receive CUES© or enhanced services as usual. RESULTS: All children met the clinical threshold for at least one anxiety disorder. Of the 26 participants randomised to CUES©, 72% attended 4-8 sessions. Parents and therapists reported they found CUES© useful and acceptable. CONCLUSIONS: Families were willing to be recruited and randomised, the format/content was feasible to deliver, and the outcome measures were acceptable. CUES© should be evaluated in a clinical and cost effectiveness randomised controlled trial.

Consensus statements on optimal adult post-autism diagnosis support and services: Delphi process following a UK survey of autistic adults, relatives and clinicians.

LAY ABSTRACT: Research has identified types of support helpful to autistic people, for example, physical and mental health interventions, psycho-education, peer support, developing positive identities and affiliation with social groups. However, accessing suitable post-autism diagnosis support and services is extremely difficult. We asked autistic adults, relatives and clinicians about their experiences of receiving and delivering post-autism diagnosis support/services. In Stage 1, 343 autistic adults and 45 relatives completed a survey. They answered questions about their experiences of UK autism post-diagnosis support/services for adults within 12 months after receiving a diagnosis. Thirty-five clinicians completed a similar survey. Just over half of adults and relatives said there was a follow-up appointment or discussion about support after diagnosis. Fewer than 40% received any support/services in 12 months after diagnosis. We used information from the surveys to create 11 statements describing characteristics of appropriate adult post-autism diagnosis support/services. In Stage 2, we asked clinicians for their views on the statements - they agreed with all of them. For example, those adults are offered an additional follow-up meeting after diagnosis and have access to mental and physical health services. We shared results with autistic adults, relatives and clinicians at two events. Some autistic adults, relatives and clinicians were positive about post-autism diagnosis support/services. However, they described many areas for improvement. The study findings can be used to define, develop and improve the types of adult post-diagnosis support services.

What is the concordance between parent- and education professional-reported adaptive functioning in autistic children using the VABS-II?

Adaptive functioning of autistic children is traditionally measured through informant-report, often from parents. Behaviour varies across settings though, and context-specific reports should be considered. Limited and inconsistent results show low parent-education professional concordance, but no research has yet explored item level response variation. We investigated Vineland Adaptive Behaviour Scales-II concordance using 233 lower ability autistic children from the PACT-G sample. Domain and item level agreement was low, but better on objectively measured behaviours. Higher child nonverbal ability improved concordance. Where disagreements occurred, education professionals identified emergent skills more and parents were more likely to rate present/absent. Parents and education professionals view the adaptive abilities of autistic children differently and both should be considered when developing personalised interventions and support.

Views about primary care health checks for autistic adults: UK survey findings.

BACKGROUND: Compared with the general population, autistic adults experience higher rates of physical and mental health conditions, premature morbidity and mortality, and barriers to health care. A health check for autistic people may improve their health outcomes. AIM: To establish the views of autistic people towards a primary care health check for autistic people. DESIGN & SETTING: Cross-sectional questionnaire study in England and Wales. METHOD: A questionnaire was sent to autistic adults with physical health conditions in England and Wales. A total of 458 people (441 autistic adults and 17 proxy responders) completed the questionnaire. RESULTS: Most responders (73.4%, n = 336) thought a health check is needed for all autistic people. Around half of the participants thought a health check should be offered from childhood and the health check appointment should last between 15 and 30 minutes. Autistic people were positive about providing primary care staff with contextual information regarding their health and the reasonable adjustments they would like before their health check appointment. Training about autism and the health check was considered important, alongside adequate time for discussions in the health check appointment (all by over 70% of responders). The clinician's autism knowledge, seeing a familiar clinician, environmental adaptations, appropriate information, and accessible appointments were considered particularly important in making a health check accessible. CONCLUSION: Autistic people and relatives were supportive of a primary care health check for autistic people. Information gathered was used to support the design of a primary care health check for autistic adults.

"We couldn't think in the box if we tried. We can't even find the damn box": A qualitative study of the lived experiences of autistic adults and relatives of autistic adults.

Autistic children grow to become autistic adults, and autism is increasingly diagnosed in adulthood and later life. This qualitative study aimed to understand experiences of autism throughout adulthood. A national cohort study of autistic adults and relatives of autistic adults (ASC-UK), enabled purposive recruitment of a diverse sample. Semi-structured interviews were conducted with 29 autistic adults (aged 20-71 years), mostly diagnosed in adulthood, and 16 relatives (aged 31-81 years) of autistic adults diagnosed across both childhood and adulthood (including some with learning disability). Interview topics included health, relationships, education, employment, quality of life and everyday experiences. Thematic analysis of the accounts of the autistic adults identified six key themes relating to their experiences: (1) diagnosis as validating yet limiting; (2) supportive and non-supportive social agents; (3) the "invisibility" of the needs of autistic adults; (4) health in the context of autism; (5) staying 'outside' the circle; and (6) multiple lives with autism. Data from relatives about autistic adult experiences gave additional perspectives on these themes. Experiences reported in other studies-of 'difference' from others, challenges of social engagement, and learning to 'conform' to society's expectations-were evident and relevant to male and female autistic adults, across all age groups, and unrelated to stage of life when diagnosed. Some expressed disappointment with their lives, but others were proud of their achievements. Education and employment, whilst challenging for many, were also rewarding for some. Health care and social services were often experienced as inaccessible, inappropriate, or lacking understanding of the individual's needs. We conclude that greater public understanding of autism as experienced in adulthood is needed. Key priorities are improving the availability of 'appropriate' health and social care services for autistic adults and families, and providing practical support to enable enhanced participation in life.

A survey of autistic adults, relatives and clinical teams in the United Kingdom: And Delphi process consensus statements on optimal autism diagnostic assessment for adults.

LAY ABSTRACT: Living with undiagnosed autism can be distressing and may affect mental health. A diagnosis of autism can help self-awareness and self-understanding. However, it can be difficult for adults to access an autism assessment. Clinicians also sometimes find it hard to identify autism in adults. This may mean an autism diagnosis is delayed or missed. In this study, we asked autistic adults, relatives and clinicians how to improve this. The study was in two stages. In the first stage (stage 1), 343 autistic adults and 45 relatives completed a survey. In the survey, we asked questions about people's experiences of UK autism assessment services for adults. Thirty-five clinicians completed a similar survey. Clinicians reported that some autism assessment teams lacked key professionals, for example, psychologists and occupational therapists. We used the information from the three separate surveys to create 13 statements describing best autism assessment services for adults. In stage 2, we asked clinicians for their views on the 13 statements. Clinicians agreed with 11 of the statements. Some autistic adults, relatives and clinicians were positive about autism assessment services, and many also described areas that could be improved. The study findings can be used to improve UK adult autism assessment services and may be helpful for service developments worldwide.

Visual attention and dietary supplementation in children with perinatal brain injury.

AIM: To investigate whether children with perinatal brain injury have impairments in specific components of visual attention, and whether early dietary supplementation can reduce any deficits. METHOD: Children participating in the Dolphin neonatal trial of dietary supplementation were tested at age 6 months with the Infant Fixation Shift Attention Test, and at 4 to 5 years with four subtests of the Early Childhood Attention Battery (ECAB) assessing different components of attention (selective, sustained, and executive function), and the Fluid Crystallized Intelligence Index of the Kaufman Assessment Battery for Children, Second Edition (KABC-II). From 59 children originally assigned to trial groups, 33 were available for testing at 4 to 5 years (18 treatment group of whom seven, six, and five showed mild, moderate, or severe neonatal brain injury; 15 controls with one, seven, and seven in the neonatal brain injury categories respectively). Given the imbalance in numbers with mild brain injury, analysis of trial group differences is restricted to moderate and severe brain injury severities (n=25). RESULTS: Children with perinatal brain injury showed poorer attention across all components relative to age norms (mean standard scores 75-87; p<0.001 for three of the four subtests), with the greatest impairment in sustained attention. These impairments remained when compared with cognitive age assessed using the Fluid Crystallized Intelligence Index. Impairment was reduced in the treatment compared to the control group (p=0.04 for flanker test, p=0.002 for counterpointing, and p=0.027 for the overall ECAB score). INTERPRETATION: Perinatal brain injury is associated with later impaired attention, beyond that predicted from any general cognitive disability. Impairment varies across attention components, being most severe for sustained attention. The effects on flanker and counterpointing suggest that dietary supplementation from 0 to 2 years of age may reduce attention problems. Measuring the different components of attention is important when considering assessment and interventions for children with perinatal brain injury.

Caregiver perspectives on the impact of uncertainty on the everyday lives of autistic children and their families.

LAY ABSTRACT: Anxiety is common in autistic children. Research shows that this may be related to intolerance of uncertainty, which is a tendency to react negatively to uncertain situations. Understanding when, why and how autistic children respond to uncertainty is important in the development of anxiety programmes. We asked 53 (including 3 dyads) parents of autistic children about the types of uncertain situations that cause difficulties for their child and how uncertainty impacts on daily life for them and their families. We found that uncertain situations made autistic children and their families feel sad, worried, frustrated and angry through the themes: child's reactions to uncertainty, trying to reduce uncertainty, the impact of difficulties with uncertainty, the impact of uncertainty on parenting and the impact on parents. There are lots of situations that are anxiety provoking for autistic children because of uncertainty, such as school. Programmes to reduce anxiety and increase autistic children's ability to cope with everyday uncertain situations could improve quality of life for autistic children and their families.

The Mediating Effects of Alexithymia, Intolerance of Uncertainty, and Anxiety on the Relationship Between Sensory Processing Differences and Restricted and Repetitive Behaviours in Autistic Adults.

Distress caused by sensory processing differences for autistic individuals may be reduced by repetitive behaviours (RRB), including repetitive motor (RMB) and insistence on sameness (ISB) behaviours. Intolerance of uncertainty (IU) and anxiety mediate the relationship between sensory processing and RRB in autistic children. We replicated this model in autistic adults, extending it to include alexithymia. Serial mediation, using data from 426 autistic adults, identified significant direct effects from sensory processing to RMB and ISB, and indirect effects through alexithymia-IU-anxiety for RMB, and IU alone, and alexithymia-IU for ISB. Different mechanisms may underpin RMB and ISB. Alexithymia alongside, IU and anxiety, should be considered when understanding the relationship between sensory processing and RRB, and when offering interventions to support autistic people.

A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Arbaclofen Administered for the Treatment of Social Function in Children and Adolescents With Autism Spectrum Disorders: Study Protocol for AIMS-2-TRIALS-CT1.

Background: Autism Spectrum Disorder (ASD or autism) is characterized by difficulties in social communication and interaction, which negatively impact on individuals and their families' quality of life. Currently no pharmacological interventions have been shown to be effective for improving social communication in autism. Previous trials have indicated the potential of arbaclofen for improving social function among autistic children and adolescents with fluent speech. The AIMS2TRIALS-Clinical Trial 1 (AIMS-CT1) will examine whether arbaclofen is superior to placebo in improving social function and other secondary outcomes over 16 weeks, along with safety and tolerability profiles. Methods: AIMS-CT1 is an international, multi-site, double-blind, parallel group Phase II randomized clinical trial. It will include 130 males and females aged 5:0-17:11 years, with a diagnosis of ASD and fluent speech. Eligible participants will be randomized on a ratio of 1:1 for a 16-week treatment period. Medication will be titrated over 5 weeks. The primary outcome is the effect on social function from weeks 0 to 16 measured on the Socialization domain of the Vineland Adaptive Behavior Scales, 3rd editionTM. Secondary outcome measures include the CGI-S (Clinical Global Impression-Severity), CGI-I (Clinical Global Impression-Improvement), other areas of adaptive function, social communication and other autism symptoms, co-occurring behavior problems and health-related quality of life. Genetic and electrophysiological markers will be examined as potential stratifiers for treatment response. Exploratory novel digital technologies will also be used to measure change, examining simultaneously the validity of digital biomarkers in natural environments. The safety and tolerability of the drug will also be examined. Our protocol is very closely aligned with a parallel Canadian trial of 90 participants (ARBA Study, US NCT number: NCT03887676) to allow for secondary combined analyses. Outcomes will be compared using both an Intent-to-reat and Per Protocol approach. Discussion: The outcomes of this trial, combined with the parallel Canadian trial, will contribute to the evidence base for medications used to help social difficulties among young autistic individuals; demonstrate the capabilities of the AIMS-2-TRIALS network of academic centers to deliver clinical trials; and support future drug development. Clinical Trial Registration: EudraCT number: 2018-000942-21 and ClinicalTrials.gov registry number: NCT03682978. Currently under protocol v.7.2, dated 20.11.2020.

How to improve healthcare for autistic people: A qualitative study of the views of autistic people and clinicians.

LAY ABSTRACT: Research has shown that on average, autistic people are more likely to die earlier than non-autistic people, and barriers can stop autistic people accessing healthcare. We carried out a study where we interviewed healthcare professionals (including doctors and nurses), and held discussion groups of autistic people. Our results highlighted several key points: seeing the same professional is important for autistic people and clinicians; both clinicians and autistic people think making adjustments to healthcare is important (and often possible); autistic people process information in a different way and so may need extra support in appointments; and that clinicians are often constrained by time pressures or targets.

The importance and availability of adjustments to improve access for autistic adults who need mental and physical healthcare: findings from UK surveys.

OBJECTIVES: To investigate autistic people's views on the importance and availability of adjustments to mental and physical healthcare provision. To explore whether specific categories of adjustments can be identified and to identify any differences in their importance and availability between mental and physical healthcare. DESIGN: Data from two studies, both employing a cross-sectional survey design. SETTING: UK-based autistic adults registered with the Adult Autism Spectrum Cohort-UK were contacted by post or online. In both studies, recruitment was staged over a 12-month period. Non-responders were sent a single reminder letter 2 weeks after initial contact. PARTICIPANTS: 537 autistic adults completed a survey about mental health services (51% response rate), 407 completed the physical health survey (49% response rate). Within these samples, 221 participants completed both surveys. PRIMARY OUTCOME MEASURES: Each study developed a bespoke survey to explore participants' views on mental and physical health services, respectively. Both included an identical list of adjustments that participants rated based on importance and availability. RESULTS: Three factors of important adjustments were identified: sensory environment, clinical and service context, and clinician knowledge and communication. Adjustments across healthcare settings were widely rated as being important yet rarely available. One significant difference between the importance of adjustments available through mental and physical health services was identified. Participants reported that having access to a clinician who is willing to adapt their approach to suit the person's preferences was significantly more important for participants attending mental health settings (p=0.001). CONCLUSIONS: Autistic people reported the limited availability of important adjustments in current healthcare provision. To address unmet need and tackle the health inequalities faced by autistic people attending physical and mental healthcare settings, healthcare providers should offer adjustments relating to the three identified factors. Future research should focus on identifying and addressing service provider barriers to implementation.

Experience of transfer from child to adult mental health services of young people with autism spectrum disorder.

BACKGROUND: Transition from child-centred to adult mental health services has been reported as challenging for young people. It can be especially difficult for young people with autism spectrum disorder (ASD) as they manage the challenges of adolescence and navigate leaving child and adolescent mental health services (CAMHS). AIMS: This study examines the predictors of transfer to adult mental health services, and using a qualitative analysis, explores the young people's experiences of transition. METHOD: A UK sample of 118 young people aged 14-21 years, with ASD and additional mental health problems, recruited from four National Health Service trusts were followed up every 12 months over 3 years, as they were discharged from CAMHS. Measures of mental health and rich additional contextual information (clinical, family, social, educational) were used to capture their experiences. Regression and framework analyses were used. RESULTS: Regression analysis showed having an attention-deficit hyperactivity disorder diagnosis and taking medication were predictors of transfer from child to adult mental health services. Several features of young people's transition experience were found to be associated with positive outcomes and ongoing problems, including family factors, education transitions and levels of engagement with services. CONCLUSIONS: The findings show the importance of monitoring and identifying those young people that might be particularly at risk of negative outcomes and crisis presentations. Although some young people were able to successfully manage their mental health following discharge from CAMHS, others reported levels of unmet need and negative experiences of transition.

The role of rare compound heterozygous events in autism spectrum disorder.

The identification of genetic variants underlying autism spectrum disorders (ASDs) may contribute to a better understanding of their underlying biology. To examine the possible role of a specific type of compound heterozygosity in ASD, namely, the occurrence of a deletion together with a functional nucleotide variant on the remaining allele, we sequenced 550 genes in 149 individuals with ASD and their deletion-transmitting parents. This approach allowed us to identify additional sequence variants occurring in the remaining allele of the deletion. Our main goal was to compare the rate of sequence variants in remaining alleles of deleted regions between probands and the deletion-transmitting parents. We also examined the predicted functional effect of the identified variants using Combined Annotation-Dependent Depletion (CADD) scores. The single nucleotide variant-deletion co-occurrence was observed in 13.4% of probands, compared with 8.1% of parents. The cumulative burden of sequence variants (n = 68) in pooled proband sequences was higher than the burden in pooled sequences from the deletion-transmitting parents (n = 41, X2 = 6.69, p = 0.0097). After filtering for those variants predicted to be most deleterious, we observed 21 of such variants in probands versus 8 in their deletion-transmitting parents (X2 = 5.82, p = 0.016). Finally, cumulative CADD scores conferred by these variants were significantly higher in probands than in deletion-transmitting parents (burden test, ß = 0.13; p = 1.0 × 10-5). Our findings suggest that the compound heterozygosity described in the current study may be one of several mechanisms explaining variable penetrance of CNVs with known pathogenicity for ASD.

A framework for an evidence-based gene list relevant to autism spectrum disorder.

Autism spectrum disorder (ASD) is often grouped with other brain-related phenotypes into a broader category of neurodevelopmental disorders (NDDs). In clinical practice, providers need to decide which genes to test in individuals with ASD phenotypes, which requires an understanding of the level of evidence for individual NDD genes that supports an association with ASD. Consensus is currently lacking about which NDD genes have sufficient evidence to support a relationship to ASD. Estimates of the number of genes relevant to ASD differ greatly among research groups and clinical sequencing panels, varying from a few to several hundred. This Roadmap discusses important considerations necessary to provide an evidence-based framework for the curation of NDD genes based on the level of information supporting a clinically relevant relationship between a given gene and ASD.

Treating anxiety in autistic adults: study protocol for the Personalised Anxiety Treatment-Autism (PAT-A©) pilot randomised controlled feasibility trial.

BACKGROUND: Anxiety is common in autistic adults and significantly limits everyday opportunities and quality of life. Evidence-based psychological therapies offered by mental health services often fail to meet the needs of autistic adults. The development of appropriate treatments for mental health conditions and, in particular, anxiety has been identified as a key priority by the autism community. The Personalised Anxiety Treatment-Autism (PAT-A©) trial aims to address this need by investigating the feasibility and acceptability of delivering an individualised psychological treatment for anxiety experienced by autistic adults. METHODS/DESIGN: This is a pilot randomised controlled feasibility trial. Up to 40 autistic adults with clinically diagnosed anxiety will be randomised into one of two groups (either the PAT-A© intervention or Current Clinical Services Plus two emotional literacy skills sessions). Before randomisation, participants will receive a detailed clinical assessment to inform formulation and guide anxiety treatment. As part of the baseline assessment participants will also identify two personally important 'target situations' that cause significant anxiety and impact upon their daily life. Based upon the formulation and identified target situations, participants randomised to the PAT-A© intervention will receive up to 12 individualised, one-to-one therapy sessions. Initial emotional literacy training sessions will be followed by a bespoke, modular, needs-based treatment approach utilising one or more of the following approaches: Mindfulness, Coping with Uncertainty in Everyday Situations (CUES), social anxiety and graded exposure within Virtual Reality Environments. Participants in the control arm will receive two psycho-educational sessions focussing on understanding and describing emotions and be signposted to healthcare provision as required. Data will be collected through quantitative and qualitative methods. DISCUSSION: This feasibility pilot trial serves as the first stage in the development and evaluation of a manualised personalised, evidence-based psychological therapy treatment for anxiety in autistic adults. Study outcomes will be used to inform an application for a fully powered multi-site intervention trial of adults and young people. TRIAL REGISTRATION: ISRCTN, ID: 15881562. Retrospectively registered on 9 August 2019.