'Walk Buds': A walking intervention to increase physical activity, physical fitness, and emotional wellbeing, in 9-13 year old children with intellectual disabilities. Results of a clustered randomised feasibility trial.

BACKGROUND: Children with intellectual disability are less physically active and more sedentary than typically developing peers. To date no studies have tested the feasibility of a school-based walking intervention for children with Intellectual Disability. METHOD: A clustered randomised controlled trial (cRCT), with an embedded process evaluation, was used to test the feasibility of a school-based walking intervention. Eight schools (n = 161 pupils aged 9-13 years) were randomised into either an intervention arm or an 'exercise as usual' arm. Measures included physical activity, physical fitness and emotional wellbeing. Baseline and 3-month follow-up data were collected. RESULTS: The 'Walk Buds' intervention was found to be acceptable to teaching staff and pupils, with an uptake rate of the walking sessions offered of 84%. CONCLUSION: A number of challenges were experienced, relating to the COVID-19 pandemic, and difficulties collecting accelerometer data. Barriers, facilitators and required changes identified through the mixed methods process evaluation are discussed.

Online social connections and Internet use among people with intellectual disabilities in the United Kingdom during the COVID-19 pandemic.

Having a disability, in particular, an intellectual disability, is associated with Internet non-use. This article explores how people with intellectual disabilities used the Internet across the United Kingdom during the COVID-19 pandemic. In April to May 2021, 571 adults with intellectual disabilities were interviewed. Participants most commonly used the Internet for being with family and friends, social media or doing online activities with other people. People who lived with family were the most likely to use social media; people who lived with other people with intellectual disabilities were the least likely. People who self-reported as not lonely were more likely to use the Internet for online activities with others and play video games with others. Social connections were identified as the best thing about the Internet. Many participants chose not to identify a worst thing about Internet use, while others reported issues with technology, online harm and threats to well-being.

What works, how and in which contexts when supporting parents to implement intensive speech and language therapy at home for children with speech sound disorder? A protocol for a realist review.

INTRODUCTION: Speech and language therapists (SLTs) worldwide report challenges with providing recommended, evidence-based intervention intensity for children with speech sound disorder (SSD). Challenges such as service constraints and/or family contexts impact on access to optimal therapy intensity. Existing research indicates that empowering and training parents to deliver intervention at home, alongside SLT support, offers one possible solution to increasing the intensity of intervention children with SSD receive. Digital health could increase accessibility to intensive home practice and help sustain engagement with therapy activities. Further exploration is needed around what makes parent-implemented interventions for children with SSD effective, for who and in which situations. This paper outlines the protocol for a realist review which aims to explore the active ingredients and contextual factors of effective digital parent-led interventions. METHODS AND ANALYSIS: A realist review will explore the research question, following six stages. The scope of the review will be determined, and initial programme theories will be developed about what works in digital parent-implemented interventions for SSD, for whom, how, why and in what circumstances. Relevant secondary data, identified through a formal search strategy, will be selected, appraised, analysed and synthesised using realist principles to test and further refine the initial programme theories. This process will develop refined underpinning explanatory theories which capture the interaction between contexts, mechanisms and outcomes of the intervention. An expert steering group will provide insight to inform explanatory theories, searches, and dissemination. ETHICS AND DISSEMINATION: Ethical approval is not required for this review. The refined programme theories from the review will inform the next stages of a wider study. A subsequent realist evaluation will test and further refine theories with key stakeholders. Following this, the underpinning programme theory will be used to coproduce a digital tool, to support parents to deliver home intervention alongside SLT support.

Stakeholder views on the barriers and facilitators of psychosocial interventions to address reduction in aggressive challenging behaviour in adults with intellectual disabilities.

Background: Success of psychosocial interventions in reducing aggressive challenging behaviour is likely to be related not only to mechanistic aspects, but also to therapeutic and system factors. The study aims to examine the facilitators and barriers that influence whether psychosocial interventions for aggressive challenging behaviour in adults with intellectual disabilities lead to positive change. Methods: We conducted 42 semi-structured interviews with adults with intellectual disabilities and aggressive challenging behaviour, family/paid carers, and professionals engaged in or delivering a psychosocial intervention across the UK. Data were analysed thematically using a framework approach. Results: Stakeholders considered therapeutic and supportive relationships and personalised care as facilitating factors of psychosocial interventions to address aggressive challenging behaviour. The operational structure of community intellectual disability services and conflicting expectations of professionals and carers were the main contextual barriers that impeded the implementation of psychosocial interventions addressing aggressive challenging behaviour in adults with intellectual disabilities. Conclusions: Findings highlight the valued components that maximise positive change in adults with intellectual disabilities who display aggressive challenging behaviour. Several operational adjustments including referral criteria, roles of professionals and workforce issues need to be addressed in services to maximise the implementation of psychosocial interventions to reduce aggressive challenging behaviour in adults with intellectual disabilities.

The current study looked at what factors that lead to good outcomes from therapies that aim to reduce aggressive challenging behaviour in adults with learning disabilities. We also looked at the factors that may prevent positive change ( i.e., reduction in aggressive challenging behaviour). We interviewed 42 people including 14 adults with learning disabilities, 13 carers (6 family; 7 paid) and 13 professionals across the UK. All stakeholders agreed that supportive relationships between the person with a learning disability and their therapist, staff consistent, personalised therapy and involvement of the person with a learning disability and their carer(s) in care planning facilitate the reduction of aggressive challenging behaviour. On the other hand, differences in expectations between professionals and carers, personal reasons ( e.g. being the right timing for a person), and the way community learning disability services currently run may stop people from having the opportunity to take part in therapy are barriers to positive change such as reduction of aggressive challenging behaviour. The study findings highlight the valued components that maximise the positive change in adults with intellectual disabilities who display aggressive challenging behaviour. Several operational adjustments including referral criteria, roles of professionals and workforce issues need to be addressed in services to maximise the implementation of psychosocial interventions to reduce aggressive challenging behaviour in adults with intellectual disabilities.

Stakeholder perspectives on intensive support teams for adults with intellectual disabilities who display behaviour that challenges in England.

BACKGROUND: Adults with intellectual disabilities often display behaviour that challenges that is a result of biological differences, psychological challenges, and lack of appropriate social support. Intensive Support Teams (IST) are recommended to support the care needs of this group and avoid hospitalisation. However, little attention has been paid to the perspectives of stakeholders who manage, work in, or use ISTs. METHOD: Interviews and focus groups were conducted with 50 stakeholders (IST service managers and professionals, adults with intellectual disabilities, and family and paid carers) of ISTs. Services operated according to one of two service models previously identified in ISTs in England (enhanced or independent). RESULTS: Thematic analysis identified accessible and flexible support, individualised care, and the involvement of carers and other relevant agencies in management plans and reviews as features of good IST care highlighted by all stakeholder groups. IST managers and professionals described the key challenges of current IST provision as unclear referral criteria, limited interfaces with other local services, and perceived threats associated with funding and staff retention. Findings were similar between the two IST models. CONCLUSIONS: ISTs are able to offer care and specialist support that is valued by families, service users and other care providers. However, they face several operational challenges that should be addressed if ISTs are to reach their potential along with community intellectual disability services in supporting adults with intellectual disabilities who display behaviour that challenges in the community.

Clinical and cost evaluation of two models of specialist intensive support teams for adults with intellectual disabilities who display behaviours that challenge: the IST-ID mixed-methods study.

BACKGROUND: Intensive support teams (ISTs) are recommended for individuals with intellectual disabilities who display behaviours that challenge. However, there is currently little evidence about the clinical and cost-effectiveness of IST models operating in England. AIMS: To investigate the clinical and cost-effectiveness of IST models. METHOD: We carried out a cohort study to evaluate the clinical and cost-effectiveness of two previously identified IST models (independent and enhanced) in England. Adult participants (n = 226) from 21 ISTs (ten independent and 11 enhanced) were enrolled. The primary outcome was change in challenging behaviour between baseline and 9 months as measured by the Aberrant Behaviour Checklist-Community version 2. RESULTS: We found no statistically significant differences between models for the primary outcome (adjusted ß = 4.27; 95% CI -6.34 to 14.87; P = 0.430) or any secondary outcomes. Quality-adjusted life-years (0.0158; 95% CI: -0.0088 to 0.0508) and costs (£3409.95; 95% CI -£9957.92 to £4039.89) of the two models were comparable. CONCLUSIONS: The study provides evidence that both models were associated with clinical improvement for similar costs at follow-up. We recommend that the choice of service model should rest with local services. Further research should investigate the critical components of IST care to inform the development of fidelity criteria, and policy makers should consider whether roll out of such teams should be mandated.

Complex interventions for aggressive challenging behaviour in adults with intellectual disability: A rapid realist review informed by multiple populations.

OBJECTIVES: Approximately 10% of people with intellectual disability display aggressive challenging behaviour, usually due to unmet needs. There are a variety of interventions available, yet a scarcity of understanding about what mechanisms contribute to successful interventions. We explored how complex interventions for aggressive challenging behaviour work in practice and what works for whom by developing programme theories through contexts-mechanism-outcome configurations. METHODS: This review followed modified rapid realist review methodology and RAMESES-II standards. Eligible papers reported on a range of population groups (intellectual disability, mental health, dementia, young people and adults) and settings (community and inpatient) to broaden the scope and available data for review. RESULTS: Five databases and grey literature were searched and a total of 59 studies were included. We developed three overarching domains comprising of 11 contexts-mechanism-outcome configurations; 1. Working with the person displaying aggressive challenging behaviour, 2. Relationships and team focused approaches and 3. Sustaining and embedding facilitating factors at team and systems levels. Mechanisms underlying the successful application of interventions included improving understanding, addressing unmet need, developing positive skills, enhancing carer compassion, and boosting staff self-efficacy and motivation. CONCLUSION: The review emphasises how interventions for aggressive challenging behaviour should be personalised and tailored to suit individual needs. Effective communication and trusting relationships between service users, carers, professionals, and within staff teams is essential to facilitate effective intervention delivery. Carer inclusion and service level buy-in supports the attainment of desired outcomes. Implications for policy, clinical practice and future directions are discussed. PROSPERO REGISTRATION NUMBER: CRD42020203055.

A scoping review of the evidence for the use of screening tools in people with intellectual disabilities with dysphagia.

BACKGROUND: Dysphagia can have serious health implications including choking and respiratory infection leading to poorer quality of life. People with intellectual disabilities are at higher risk of dysphagia related health complications and early death. Robust dysphagia screening tools are vital for this population. METHOD: A scoping review and appraisal of the evidence for dysphagia and feeding screening tools for use with people with intellectual disabilities was undertaken. RESULTS: Seven studies (using six screening tools) met the review inclusion criteria. Mostly studies were limited by no defined dysphagia criteria, no verification of tools with a gold reference standard (e.g., videofluoroscopic examination) and lack of participant diversity (small samples, narrow age range, severity of intellectual disability or limited settings). CONCLUSIONS: There is urgent need for development and rigorous appraisal of existing dysphagia screening tools to meet the needs of a wider range of people with intellectual disabilities (particularly mild-to-moderate severity) and in wider settings.

Using a hospital passport from the perspective of adults with intellectual disabilities, family carers and health professionals: A qualitative study.

This article explores the experiences of the use of the Regional Health and Social Care Hospital Passport (Regional Hospital Passport) in Northern Ireland from the perspectives of adults with intellectual disabilities, family carers and health professionals. From semi-structured interviews three themes emerged: usefulness; facilitators; and barriers to the use of the Regional Hospital Passport. There were clear benefits of the Hospital Passport when used across hospital services and clinical practice settings such as dental and General Practices. There was participant agreement that communication and the person-centred care experiences were enhanced. Findings suggest that providers of health and social care services need to take greater responsibility and accountability for ensuring Regional Hospital Passports are promoted and used across all settings. There is a requirement to develop the wider use and uptake of hospital passports to support adults with intellectual disabilities, with potential for use with other patient groups.

'Walk Buds': A walking programme to increase physical activity, physical fitness and emotional wellbeing, in 9-13 yr old children with intellectual disability. A study protocol for a clustered RCT.

BACKGROUND: Young people with intellectual disabilities are traditionally less physically fit compared to their non-disabled peers. While the health benefits of increasing physical activity are evident, there remains a lack of evidence on how to increase physical activity and reduce sedentary behaviour in young people with intellectual disabilities. Walking interventions, including those delivered in school settings, have been found to significantly increase physical activity levels of young people without disabilities. However, to date there has been a paucity of studies testing walking interventions for young people with intellectual disabilities in school settings. In an earlier study we developed the Walk Buds school-based walking programme for children with intellectual disability (aged 9-13 yrs), which incorporated a paired buddy component. AIM: We plan to conduct a clustered feasibility RCT that will enable us to examine the acceptability of the Walk Buds programme, randomisation, and outcome measures, check the fidelity programme delivery, and identify the facilitators and barriers to the implementation of the programme. METHODS: This study is a two-arm, cRCT feasibility trial where eight schools will be randomised into either an intervention arm (Walk Buds) or an 'exercise as usual' arm. We are aiming to recruit between 130 and 160 young people with intellectual disabilities. Outcome measures will be recorded at baseline and three-months post-intervention. A process evaluation will explore the factors that could impact on the internal and external validity of a future cRCT and the intervention's logic model. DISCUSSION: Walk Buds is the first theoretically underpinned, peer-led, multi-component, manualised school-based walking programme that aims to increase physical activity, physical fitness, and emotional wellbeing in 9-13 yr old children with intellectual disabilities.

Exploring the effects of socio-economic inequalities on health and disability in Northern Irish adolescents: evidence from a nationally representative longitudinal study.

Although a negative association between socio-economic inequalities and health has been established, there is a dearth of robust longitudinal studies examining this relationship in adolescents. This study used a large, nationally representative longitudinal data set to investigate the association between socio-economic inequality, subjective health status and disabilities among young people in Northern Ireland over a ten-year period. Data were from the Northern Ireland Longitudinal Study, a census-based record linkage study (N = 46,535). Logistic regression models were estimated in which health and disability variables from the 2011 census were predicted by household deprivation in education, housing quality, housing tenure and employment from the 2001 census. Models were adjusted for health and disability status in 2001. Deprivation in employment, housing tenure and coming from a single-parent household in 2001 independently predicted poorer subjective health and disability status ten years later [ORs = 1.28-1.93]. Deprivation in education in 2001 was also associated with increased risk of disability in 2011 [OR = 1.15; 95% CI = 1.06-1.25]. These results show that there is a need to dedicate more resources and support for economically disadvantaged children and young people in Northern Ireland, where child health outcomes are poorer than in the rest of the UK.

Exploring the knowledge base of trauma and trauma informed care of staff working in community residential accommodation for adults with an intellectual disability.

BACKGROUND: Taking a trauma informed care approach has demonstrated positive outcomes for services for people in the general population. Given the increased vulnerability to psychological trauma for adults with an intellectual disability, this study explores what residential staff know about trauma and trauma informed care. METHODS: Thirty-two staffs representing three staff groups: direct care staff; managers; and specialist practitioners, were interviewed using semi-structured interviews, which were analysed following a structured framework. FINDINGS: Each staff group held different perspectives in their knowledge of trauma and trauma informed care. Limitations were noted in staffs' knowledge of trauma, implementation of evidence-based supports, and access to specialist services for adults with an intellectual disability. All participants highlighted their training needs regarding trauma. CONCLUSION: Increased training on recognising and responding to trauma is needed among community staff supporting those with a trauma history if organisations are to move towards trauma informed care.

Determining the need for a breast cancer awareness educational intervention for women with mild/moderate levels of intellectual disability: A qualitative descriptive study.

OBJECTIVE: Following a review of the existing body of literature, this study aimed to explore the need for a breast cancer awareness intervention specifically targeted at women with mild/moderate levels of intellectual disability (ID) and provide perspectives on the preferred processes and content underpinning an intervention. METHODS: A qualitative, descriptive design using semi-structured, individual (n = 5) and focus group (n = 5) interviews were used to engage with a non-probability, purposive sample of key stakeholders (n = 25) including women with mild/moderate levels of ID, caregivers and healthcare professionals. Data were analysed using qualitative content analysis. RESULTS: Findings highlighted that an educational intervention should focus on breast awareness as opposed to breast cancer awareness. Additionally, findings identified that a combined breast awareness and healthy living intervention could be effective. However, the intervention needs to have a multimodal, hands-on, person-centred approach to learning which is underpinned by theory. Furthermore, integrating the caregivers and healthcare professionals into the intervention is recommended. CONCLUSION: Findings from this study provide a foundation for developing and implementing a theoretically underpinned, multimodal, breast awareness and healthy living educational intervention for women with mild/moderate levels of ID.

Estimation of the minimal clinically important difference on the Aberrant Behaviour Checklist-Irritability (ABC-I) for people with intellectual disabilities who display aggressive challenging behaviour: A triangulated approach.

BACKGROUND: The minimal clinically important difference (MCID) is relevant in the estimation of improvement in a patient outcome. AIM: To determine the MCID on the Aberrant Behaviour Checklist-Irritability (ABC-I), widely used to measure the effects of intervention for aggressive challenging behaviour in people with intellectual disabilities. METHOD AND PROCEDURES: We utilised distribution and anchor based methods to estimate the ABC-I MCID. We extracted data from 15 randomised controlled trials (RCTs) for meta-analysis. We conducted three online workshops with family carers and professionals to consider meaningful change in case vignettes of increasing severity of aggressive challenging behaviour. OUTCOMES AND RESULTS: We did not find overlap in the range of values between the two approaches. The meta-analysis indicated a range of MCID on the ABC-I (0.05, 4.94) whilst the anchor-based estimation indicated a larger change (6.6, 16.6). CONCLUSIONS AND IMPLICATIONS: The MCID is essential in interpreting the results from intervention studies. The present work was undertaken as part of a wider programme on the development and testing of a psychosocial intervention for aggressive challenging behaviour, and it is of interest to researchers in justifying how they choose and determine the MCID on the outcome of interest.

Barriers and facilitators of physical activity in adolescents with intellectual disabilities: An analysis informed by the COM-B model.

BACKGROUND: Adolescents with intellectual disabilities are insufficiently physically active. Where interventions have been developed and delivered, these have had limited effectiveness, and often lack a theoretical underpinning. AIM: Through application of the COM-B model, our aim is to explore the factors influencing adolescent physical activity within schools. METHODS: A qualitative methodology, using focus groups with students who have mild/moderate intellectual disabilities, their parents'/carers' and teachers'. The COM-B model provided the lens through which the data were collected and analysed. RESULTS: We identified of a range of individual, interpersonal, and environmental factors influencing physical activity, across all six COM-B constructs, within the context of the 'school-system'. CONCLUSION: This is the first study to use the COM-B model to explore school-based physical activity behaviour, for adolescents with intellectual disabilities. Identification of such physical activity behavioural determinants can support the development of effective and sustainable interventions.

Developing curricular-content and systems-related impact indicators for intellectual disability awareness training for acute hospital settings: A modified International Delphi Survey.

AIM: To identify, and reach consensus on, curricular-content and delivery methods, as well as ways to maximize the impact of intellectual disability awareness training programmes in acute hospital settings. BACKGROUND: With the continuing evidence of avoidable deaths and unwarranted variations in the quality of care to people with an intellectual disability in acute hospitals, it could be purported that current training provided to hospital staff appears to be making a minimal difference in the care provided to this population. DESIGN: A two-round modified Delphi survey was conducted between June 2020-January 2021. METHODS: International experts from primary healthcare and hospital settings, and intellectual disability health fields participated in the survey. Initial curricular-content items were developed from the literature, and based on the combined clinical and academic experience base of the authors. Items were evaluated in terms of agreement/consensus, importance and stability of responses. There were 57 expert responses in Round 1 and 45 in Round 2. RESULTS: The consensus was reached with regard to 55 of 65 curricular-content indicators relating to Aims, Design, Content and Delivery. Ten curricular-content indicators failed to be agreed on relating to the mode of training delivery. With regard to systems-related impact indicators, 28 out of 31 reached consensus. The expert panel identified and agreed on seven system barriers that could obstruct the successful implementation of the awareness training programmes in acute hospital settings. CONCLUSIONS: This is the first international Delphi survey to agree on curricular-content and identify systems-related facilitators for intellectual disability awareness training. Potential system barriers have been highlighted which could be addressed by systemic improvement. Implications for developing, and robustly testing the efficacy of, intellectual disability awareness training programmes are discussed, as are the implications for other cognitively impaired populations. IMPACT: In order to maximize the impact, investment in acute hospital staff education will need to be accompanied by wider changes to systems and structures concerning the governance of service provision for people with an intellectual disability.

The Use of Psychotropic Medication in Iranian Children with Developmental Disabilities.

The use of psychotropic medication in children is increasing worldwide. Children with developmental disabilities seem to be prescribed these medications at a higher rate compared to their non-disabled peers. Little is known about prescribing in non-Western, middle-income studies. In Iran, the file records of 1133 children, aged 2 to 17 years, assessed as having autism spectrum disorder (ASD) or an intellectual disability (ID) in Tehran City and Province from 2005 to 2019 were collated, and information from parental reports of medications was extracted. Upwards of 80% of children with ASD and 56% of those with ID were prescribed a psychotropic medication with around one quarter in each group taking two or more medications. The rates were higher among male children showing difficult-to-manage behaviors such as hyperactivity, but less so for children of fathers with higher levels of education. The lack of alternative management strategies may be a significant driver for the use of psychotropic medications in Iran and other Low and Middle Income countries, despite their known side effects, and their failure to address the developmental needs of the children. Rather, multi-disciplinary, behavioral, therapeutic, and educational interventions are required, but these are not available widely in Iran, although a start has been made.

Trauma experiences of people with an intellectual disability and their implications: A scoping review.

BACKGROUND: People with an intellectual disability are more vulnerable to psychological trauma compared with the general population. The aim of this scoping review was to identify the current status of the literature on trauma that is specific to the experiences of adults with an intellectual disability, living in community settings. METHODS: A scoping review was conducted using the Arksey and O'Malley (International Journal of Social Research Methodology, 2005, 8, 19) framework. Forty-one international papers were reviewed spanning 2000-2020, and their quality assessed using the MMAT. FINDINGS: (1) Aggressive behaviours can be symptoms of trauma, (2) there are appropriate assessment tools for the impact of trauma, (3) evidence-based interventions for trauma may be effective, and (4) factors associated with disability can be experienced as traumatic. CONCLUSION: There is a growing body of literature highlighting assessment needs and potential interventions for people with an intellectual disability who have experienced psychological trauma. Further research is needed to develop trauma-informed pathways.

Defining breast cancer awareness and identifying barriers to breast cancer awareness for women with an intellectual disability: A review of the literature.

INTRODUCTION: Incidence rates for developing breast cancer are similar for women regardless of intellectual ability. However, women with an intellectual disability present with advanced breast cancers, which often have a poor prognosis. METHOD: A structured narrative review of the literature was performed to explore the concepts of breast awareness and breast cancer awareness and subsequently, identify barriers to breast cancer awareness encountered by women with an intellectual disability. RESULTS: A total of 22 studies involving people with varying levels of intellectual disability informed this review. The barriers to breast cancer awareness encountered by women with an intellectual disability include: lack of their understanding, the role of the carer and literacy issues. CONCLUSION: Identifying the barriers to breast cancer awareness for women with an intellectual disability will help to facilitate breast cancer awareness which has the potential to result in better long-term outcomes through an early diagnosis of breast cancer.

Clinical and cost evaluation of intensive support team (IST) models for adults with intellectual disabilities who display challenging behaviour: a comparative cohort study protocol.

INTRODUCTION: Approximately 17% of adults with intellectual disabilities (ID) living in the community display behaviours that challenge. Intensive support teams (ISTs) have been recommended to provide high-quality responsive care aimed at avoiding unnecessary admissions and reducing lengthy inpatient stays in England. We have identified two models of ISTs (model 1: enhanced provision and model 2: independent provision). This study aims to investigate the clinical and cost-effectiveness of the two models of ISTs. METHODS AND ANALYSIS: A cohort of 226 adults with ID displaying behaviour that challenges who receive support from ISTs from each model will be recruited and assessed at baseline and 9 months later to compare the clinical and cost-effectiveness between models. The primary outcome is reduction in challenging behaviour measured by the Aberrant Behaviour Checklist-Community (ABC-C). The mean difference in change in ABC score between the two IST models will be estimated from a multilevel linear regression model. Secondary outcomes include mental health status, clinical risk, quality of life, health-related quality of life, level of functioning and service use. We will undertake a cost-effectiveness analysis taking both a health and social care and wider societal perspective. Semistructured interviews will be conducted with multiple stakeholders (ie, service users, paid/family carers, IST managers/staff) to investigate the experience of IST care as well as an online survey of referrers to capture their contact with the teams. ETHICS AND DISSEMINATION: The study was approved by the London-Bromley Research Ethics Committee (REC reference: 18/LO/0890). Informed consent will be obtained from the person with ID, or a family/nominated consultee for those lacking capacity and from his/her caregivers. The findings of the study will be disseminated to academic audiences, professionals, experts by experience and arm's-length bodies and policymakers via publications, seminars and digital platforms. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03586375).