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To understand whether the mental health of children and young people (CYP) with and without attention-deficit/hyperactivity disorder (ADHD) and/or autism spectrum disorder (ASD) were differentially affected by COVID-19. We analysed data (n = 6507) from the Co-Space study, a UK web-based longitudinal survey. CYP with ADHD (n = 160;2.5%), ASD (n = 465;7%), and ADHD + ASD (n = 155;2.4%) were compared with a reference group (n = 5727;88%) using parent-completed questionnaires [Strengths and Difficulties Questionnaire (SDQ) & Pandemic Anxiety Scale (PAS)]. Baseline to 1-month follow-up differences were compared using linear regression models. CYP with ADHD and/or ASD had higher scores at baseline than other CYP. At follow-up, CYP with ASD showed small but significant improvements in symptoms (SDQ), compared with the reference group. CYP with ASD experienced a worsening of disease anxiety (PAS) and CYP with ADHD a deterioration in functional impairment. These findings indicate a mixed pattern of pandemic-related impact for CYP with ADHD and/or ASD.
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BACKGROUND: In response to COVID-19, there has been increasing momentum in telehealth development and delivery. To assess the anticipated exponential growth in telehealth, it is important to accurately capture how telehealth has been used in specific mental health fields prior to the pandemic. OBJECTIVE: This systematic review aimed to highlight how telehealth has been used with clinical samples in the neurodevelopmental field, including patients with neurodevelopmental disorders (NDDs), their families, and health care professionals. To identify which technologies show the greatest potential for implementation into health services, we evaluated technologies for effectiveness, economic impact, and readiness for clinical adoption. METHODS: A systematic search of literature was undertaken in April 2018 and updated until December 2019, by using the Medline, Web of Science, Scopus, CINAHL Plus, EMBASE, and PsycInfo databases. Extracted data included the type of technology, how the technology was used (ie, assessment, treatment, and monitoring), participant characteristics, reported outcomes and authors' views on clinical effectiveness, user impact (ie, feasibility and acceptability), economic impact, and readiness for clinic adoption. A quality review of the research was performed in accordance with the Oxford Centre for Evidence-Based Medicine Levels of Evidence. RESULTS: A total of 42 studies met the inclusion criteria. These studies included participants and family members with autism spectrum disorders (21/42, 50%), attention deficit hyperactivity disorders (8/42, 19%), attention deficit hyperactivity or autism spectrum disorders (3/42, 7%), communication disorders (7/42, 17%), and tic disorders (2/42, 5%). The focus of most studies (33/42, 79%) was on treatment, rather than assessment (4/42, 10%) or monitoring (5/42, 12%). Telehealth services demonstrated promise for being clinically effective, predominantly in relation to diagnosing and monitoring NDDs. In terms of NDD treatment, telehealth services were usually equivalent to control groups. There was some evidence of positive user and economic impacts, including increased service delivery efficiency (eg, increased treatment availability and decreased waiting times). However, these factors were not widely recorded across the studies. Telehealth was demonstrated to be cost-effective in the few studies that considered cost-effectiveness. Study quality varied, as many studies had small sample sizes and inadequate control groups. Of the 42 studies, only 11 (26%) were randomized controlled trials, 12 (29%) were case studies or case series, 6 (14%) were qualitative studies, and 5 (12%) were noncomparative trials. CONCLUSIONS: Telehealth has the potential to increase treatment availability, decrease diagnosis waiting times, and aid in NDD monitoring. Further research with more robust and adequately powered study designs that consider cost-effectiveness and increased efficiency is needed. This systematic review highlights the extent of telehealth technology use prior to the COVID-19 pandemic and the movement for investing in remote access to treatments. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42018091156; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42018091156.
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Monitorização Fisiológica/métodos , Transtornos do Neurodesenvolvimento/terapia , Telemedicina/métodos , Feminino , Humanos , Masculino , Transtornos do Neurodesenvolvimento/epidemiologia , Pesquisa QualitativaRESUMO
BACKGROUND: Diagnosis of attention deficit hyperactivity disorder (ADHD) relies on subjective methods which can lead to diagnostic uncertainty and delay. This trial evaluated the impact of providing a computerised test of attention and activity (QbTest) report on the speed and accuracy of diagnostic decision-making in children with suspected ADHD. METHODS: Randomised, parallel, single-blind controlled trial in mental health and community paediatric clinics in England. Participants were 6-17 years-old and referred for ADHD diagnostic assessment; all underwent assessment-as-usual, plus QbTest. Participants and their clinician were randomised to either receive the QbTest report immediately (QbOpen group) or the report was withheld (QbBlind group). The primary outcome was number of consultations until a diagnostic decision confirming/excluding ADHD within 6-months from baseline. Health economic cost-effectiveness and cost utility analysis was conducted. Assessing QbTest Utility in ADHD: A Randomised Controlled Trial was registered at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02209116). RESULTS: One hundred and thirty-two participants were randomised to QbOpen group (123 analysed) and 135 to QbBlind group (127 analysed). Clinicians with access to the QbTest report (QbOpen) were more likely to reach a diagnostic decision about ADHD (hazard ratio 1.44, 95% CI 1.04-2.01). At 6-months, 76% of those with a QbTest report had received a diagnostic decision, compared with 50% without. QbTest reduced appointment length by 15% (time ratio 0.85, 95% CI 0.77-0.93), increased clinicians' confidence in their diagnostic decisions (odds ratio 1.77, 95% CI 1.09-2.89) and doubled the likelihood of excluding ADHD. There was no difference in diagnostic accuracy. Health economic analysis showed a position of strict dominance; however, cost savings were small suggesting that the impact of providing the QbTest report within this trial can best be viewed as 'cost neutral'. CONCLUSIONS: QbTest may increase the efficiency of ADHD assessment pathway allowing greater patient throughput with clinicians reaching diagnostic decisions faster without compromising diagnostic accuracy.
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Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Atenção , Diagnóstico por Computador/métodos , Atividade Motora , Adolescente , Transtorno do Deficit de Atenção com Hiperatividade/psicologia , Criança , Análise Custo-Benefício , Tomada de Decisões Assistida por Computador , Feminino , Humanos , Masculino , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Método Simples-CegoRESUMO
BACKGROUND: The diagnosis and monitoring of Attention deficit hyperactivity disorder (ADHD) typically relies on subjective reports and observations. Objective continuous performance tests (CPTs) have been incorporated into some services to support clinical decision making. However, the feasibility and acceptability of adding such a test into routine practice is unknown. The study aimed to investigate the feasibility and acceptability of adding an objective computerised test to the routine assessment and monitoring of attention deficit hyperactivity disorder (ADHD). METHODS: Semi-structured interviews were conducted with clinicians (n = 10) and families (parents/young people, n = 20) who participated in a randomised controlled trial. Additionally, the same clinicians (n = 10) and families (n = 76) completed a survey assessing their experience of the QbTest. The study took place in child and adolescent mental health and community paediatric clinics across the UK. Interview transcripts were thematically analysed. RESULTS: Interviewed clinicians and families valued the QbTest for providing an objective, valid assessment of symptoms. The QbTest was noted to facilitate communication between clinicians, families and schools. However, whereas clinicians were more unanimous on the usefulness of the QbTest, survey findings showed that, although the majority of families found the test useful, less than half felt the QbTest helped them understand the clinician's decision making around diagnosis and medication. The QbTest was seen as a potentially valuable tool to use early in the assessment process to streamline the care pathway. Although clinicians were conscious of the additional costs, these could be offset by reductions in time to diagnosis and the delivery of the test by a Healthcare Assistant. CONCLUSIONS: The findings indicate the QbTest is an acceptable and feasible tool to implement in routine clinical settings. Clinicians should be mindful to discuss the QbTest results with families to enable their understanding and engagement with the process. Further findings from definitive trials are required to understand the cost/benefit; however, the findings from this study support the feasibility and acceptability of integrating QbTest in the ADHD care pathway. TRIAL REGISTRATION: The findings form the implementation component of the Assessing QbTest Utility in ADHD (AQUA) Trial which is registered with the ISRCTN registry ( ISRCTN11727351 , retrospectively registered 04 July 2016) and clinicaltrials.gov ( NCT02209116 , registered 04 August 2014).
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Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Atitude do Pessoal de Saúde , Diagnóstico por Computador/métodos , Testes Neuropsicológicos , Adolescente , Adulto , Transtorno do Deficit de Atenção com Hiperatividade/psicologia , Criança , Família , Feminino , Humanos , Masculino , Inquéritos e QuestionáriosRESUMO
Attention-deficit hyperactivity disorder (ADHD) is typically diagnosed using clinical observation and subjective informant reports. Once children commence ADHD medication, robust monitoring is required to detect partial or non-responses. The extent to which neuropsychological continuous performance tests (CPTs) and objective measures of activity can clinically aid the assessment and titration process in ADHD is not fully understood. This review describes the current evidence base for the use of CPTs and objectively measured activity to support the diagnostic procedure and medication management for children with ADHD. Four databases (PsycINFO, Medline, Allied and Complementary Medicine (AMED), and PsycARTICLES) were systematically searched to understand the current evidence base for (1) the use of CPTs to aid clinical assessment of ADHD; (2) the use of CPTs to aid medication management; and (3) the clinical utility of objective measures of activity in ADHD. Sixty relevant articles were identified. The search revealed six commercially available CPTs that had been reported on for their clinical use. There were mixed findings with regard to the use of CPTs to assess and manage medication, with contrasting evidence on their ability to support clinical decision-making. There was a strong evidence base for the use of objective measures of activity to aid ADHD/non-ADHD group differentiation, which appears sensitive to medication effects and would also benefit from further research on their clinical utility. The findings suggest that combining CPTs and an objective measure of activity may be particularly useful as a clinical tool and worthy of further pursuit.
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Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Testes Neuropsicológicos/normas , Desempenho Psicomotor/fisiologia , Transtorno do Deficit de Atenção com Hiperatividade/fisiopatologia , Criança , HumanosRESUMO
BACKGROUND: Diagnosing attention deficit/hyperactivity disorder (ADHD) in children and young people typically relies on clinical observation and subjective parent, teacher and self-reports. The subjective nature of reports combined with contradictory or missing data can result in diagnostic uncertainty and delay. The aim of this study was to assess whether the addition of an objective test of attention, impulsivity and activity (QbTest) as an adjunct to standard ADHD assessment could accelerate the diagnostic process in routine National Health Service (NHS) settings. METHOD: In a pre vs. post-test audit design, case records were examined in 40 cases diagnosed without the QbTest [pre-QbTest group] and 40 cases diagnosed with the QbTest [QbTest group], recording the number of consultations until a confirmed ADHD diagnosis was reached. RESULTS: Using Poisson regression, significantly fewer clinician consultations (mean 2.18 vs. 3.05; p < .02) were required to confirm the diagnosis of ADHD when the QbTest was used to augment assessment in comparison to standard assessment as usual. CONCLUSIONS: The findings suggest that the addition of the QbTest to standard clinical assessment may reduce time to diagnosis and potentially result in cost savings to the NHS. These preliminary data suggest that there is a potentially clinically meaningful benefit of adding the QbTest to routine clinical ADHD assessment and this should be examined next in the context of a randomised controlled trial.
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BACKGROUND: Interventions for parents of children experiencing emotional and/or behavioural difficulties can help to improve their children's health, educational and social outcomes. However, the desirability and acceptability of screening and offering such interventions for attention-deficit hyperactivity disorder (ADHD)-type problems are currently unclear. This article is a qualitative process evaluation of a pragmatic cluster randomised controlled trial (Trial registration: ISRCTN87634685; reported elsewhere) to assess the feasibility and acceptability of a school-based parenting intervention programme for parents and teachers of children with high levels of ADHD symptoms. METHODS: Parents (n = 22) and teaching staff (n = 29) took part in semi-structured group or individual interviews, either by telephone or face-to-face, following the main trial. Interviews were digitally-recorded, transcribed verbatim and subjected to thematic analysis. RESULTS: The parenting intervention was acceptable to parents and teachers, and they were enthusiastic about the need for parenting groups in the school environment and stressed the importance of parent-school collaboration. Parents generally stated a preference for universal recruitment approaches to such programmes whilst teachers described the need to target specific parents. Most parents who took part in the parenting intervention described it favourably and many saw benefits, at least in the short-term. Parents differed in their preferred group size, with some desiring one-to-one sessions and others favouring a larger group. Non-attending parents reported barriers to attendance such as fear of attending in a group, previous use of the programme, work and other commitments. Suggestions to improve the programme included: clearer communication; offering booster sessions; and greater collaboration with teachers. CONCLUSIONS: It is feasible to deliver parenting intervention programmes within or near schools. The intervention was acceptable to the majority of parents, thus retention was high, but recruitment was difficult and reaching the parents with the most need was challenging. The findings of the process evaluation identified greater benefits to families than were apparent in the main trial. Recommendations identified by parents and teaching staff may be used to inform service delivery and future research to enhance recruitment to parenting interventions in the school environment.
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Transtorno do Deficit de Atenção com Hiperatividade/prevenção & controle , Terapia Comportamental/métodos , Poder Familiar , Adolescente , Transtorno do Deficit de Atenção com Hiperatividade/psicologia , Criança , Transtornos do Comportamento Infantil/prevenção & controle , Transtornos do Comportamento Infantil/psicologia , Revelação , Docentes , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pais/psicologia , Serviços de Saúde Escolar , Instituições AcadêmicasRESUMO
QUESTION: Children and young people experience delays in assessment and/or treatment within mental health services. The objective of this systematic review, funded by the Emerging Minds Network, was to explore the current evidence base for mental health waiting list interventions to support children and young people. STUDY SELECTION AND ANALYSIS: A literature search was conducted in MEDLINE, PsycINFO, Web of Science and the Cochrane databases from 2000 to 2023 (last searched October 2023). Included studies described interventions to support children and young people and/or their family while on a waiting list for child and adolescent mental health services. Titles and abstracts were screened independently by two reviewers, data were extracted by one reviewer, confirmed by a second and a narrative synthesis was provided. FINDINGS: Eighteen studies including 1253 children and young people were identified. Studies described waiting list interventions for autism spectrum disorders, eating disorders, generic conditions, transgender health, anxiety/depression, self-harm and suicide and behavioural issues. Many interventions were multicomponent; 94% involved psychoeducation, other components included parental support, bibliotherapy and coaching. Duration of the interventions ranged from a single session to over a year; 66% involved face-to-face contact. All studies demonstrated benefits in terms of improved clinical outcomes and/or feasibility/acceptability. Evidence for service outcomes/efficiency was largely unexplored. Limitations of the underpinning research, such as sample size and low-quality papers, limit the findings. CONCLUSIONS: There is limited research exploring waiting list interventions, however, the findings from small-scale studies are promising. Further research using robust study designs and real-world implementation studies are warranted.
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Serviços de Saúde Mental , Suicídio , Criança , Humanos , Adolescente , Listas de Espera , Depressão/terapia , Saúde MentalRESUMO
BACKGROUND: To contextualize the benefits of an intervention, it is important that adverse events (AEs) are reported. This is potentially difficult in trials of digital mental health interventions, where delivery may be remote and the mechanisms of actions less understood. OBJECTIVE: We aimed to explore the reporting of AEs in randomized controlled trials of digital mental health interventions. METHODS: The International Standard Randomized Controlled Trial Number database was searched for trials registered before May 2022. Using advanced search filters, we identified 2546 trials in the category of mental and behavioral disorders. These trials were independently reviewed by 2 researchers against the eligibility criteria. Trials were included where digital mental health interventions for participants with a mental health disorder were evaluated through a completed randomized controlled trial (protocol and primary results publication published). Published protocols and primary results publications were then retrieved. Data were extracted independently by 3 researchers, with discussion to reach consensus when required. RESULTS: Twenty-three trials met the eligibility criteria, of which 16 (69%) included a statement on AEs within a publication, but only 6 (26%) reported AEs within their primary results publication. Seriousness was referred to by 6 trials, relatedness by 4, and expectedness by 2. More interventions delivered with human support (9/11, 82%) than those with only remote or no support (6/12, 50%) included a statement on AEs, but they did not report more AEs. Several reasons for participant dropout were identified by trials that did not report AEs, of which some were identifiable or related to AEs, including serious AEs. CONCLUSIONS: There is significant variation in the reporting of AEs in trials of digital mental health interventions. This variation may reflect limited reporting processes and difficulty recognizing AEs related to digital mental health interventions. There is a need to develop guidelines specifically for these trials to improve future reporting.
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This study aimed to explore the impact of food allergy on quality of life in children with food allergy and their primary caregivers, compared to a healthy non-food allergy comparison group. Food allergy children (n=34) and control children (n=15), aged 8-12, and their respective primary caregivers (n=30/n=13), completed generic quality of life scales (PedsQL™ and WHOQOLBREF) and were asked to take photographs and keep a diary about factors that they believed enhanced and/or limited their quality of life, over a one-week period. Questionnaire analysis showed that parents of children with food allergy had significantly lower quality of life in the social relationships domain and lower overall quality of life than the comparison parents. In contrast, children with food allergy had similar or higher quality of life scores compared to comparison children. Content analysis of photograph and diary data identified ten themes that influenced both child and parental quality of life. It was concluded that although food allergy influenced quality of life for some children, their parent's quality of life was hindered to a greater extent. The variability in findings highlights the importance of assessing quality of life in individual families, considering both children with allergies and their primary caregivers.
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Família , Hipersensibilidade Alimentar , Qualidade de Vida , Atividades Cotidianas , Estudos de Casos e Controles , Criança , Feminino , Alimentos , Nível de Saúde , Humanos , Masculino , Pais , Projetos Piloto , Fatores Socioeconômicos , Inquéritos e QuestionáriosRESUMO
The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) is a widely used scale that measures the core symptoms of attention deficit hyperactivity disorder (ADHD). However, there are contradictory findings regarding factor structure. Factor structure and measurement equivalence/invariance analysis on parent and teacher SNAP-IV for children referred for an ADHD assessment (N = 250; 6-17 years), revealed a two-factor structure provided the best fit. SNAP-IV scores were also compared with clinician diagnosis of ADHD and research diagnoses of ADHD and hyperkinetic disorder. Parent ratings of inattention and hyperactivity/impulsivity were good predictors of research but not clinician diagnosis. For teacher ratings, only hyperactivity/impulsivity scores were associated with research and clinician diagnosis. SNAP-IV scores showed high sensitivity but low specificity to clinician diagnosis. The SNAP-IV is a valid outcome measure for use in randomized controlled trials and clinical settings, and is best used as a screening rather than a diagnostic tool for ADHD.
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Transtorno do Deficit de Atenção com Hiperatividade , Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Criança , Coleta de Dados , Humanos , Programas de Rastreamento , PaisRESUMO
Technology-based interventions provide an attractive option for improving service provision for neurodevelopmental disorders (NDD), for example, widening access to interventions, objective assessment, and monitoring; however, it is unclear whether there is sufficient evidence to support their use in clinical settings. This review provides an evidence map describing how technology is implemented in the assessment/diagnosis and monitoring/ treatment of NDD (Prospero CRD42018091156). Using predefined search terms in six databases, 7982 articles were identified, 808 full-texts were screened, resulting in 47 included papers. These studies were appraised and synthesised according to the following outcomes of interest: effectiveness (clinical effectiveness/ service delivery efficiencies), economic impact, and user impact (acceptability/ feasibility). The findings describe how technology is currently being utilised clinically, highlights gaps in knowledge, and discusses future research needs. Technology has been used to facilitate assessment and treatment across multiple NDD, especially Autism Spectrum (ASD) and attention-deficit/hyperactivity (ADHD) disorders. Technologies include mobile apps/tablets, robots, gaming, computerised tests, videos, and virtual reality. The outcomes presented largely focus on the clinical effectiveness of the technology, with approximately half the papers demonstrating some degree of effectiveness, however, the methodological quality of many studies is limited. Further research should focus on randomised controlled trial designs with longer follow-up periods, incorporating an economic evaluation, as well as qualitative studies including process evaluations and user impact.
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Transtornos do Neurodesenvolvimento/diagnóstico , Tecnologia , Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Transtorno do Deficit de Atenção com Hiperatividade/terapia , Transtorno do Espectro Autista/diagnóstico , Transtorno do Espectro Autista/terapia , Análise Custo-Benefício , Feminino , Humanos , Masculino , Transtornos do Neurodesenvolvimento/terapia , Resultado do TratamentoRESUMO
BACKGROUND: The Strengths and Difficulties Questionnaire (SDQ) is widely used to assess child and adolescent mental health problems. However, the factor structure of the SDQ is subject to debate and there is limited evidence investigating measurement equivalence invariance (ME/I) between treatment groups, informants, and across time. METHOD: A randomised controlled trial (RCT) recruited 250 participants (6-17 years) who had been referred for an attention deficit hyperactivity disorder (ADHD) assessment. Participants and their clinician either received or did not receive a QbTest report (computer task measuring attention, impulsivity and activity). Parents and teachers completed the SDQ at baseline and 6-months later. This study aimed to understand the factor structure of the SDQ in a clinic referred ADHD sample, and validate the scale as a screening/diagnostic aide and as a measure of treatment outcome both in clinical and research settings. Exploratory Structural Equation Modelling (ESEM) was performed to examine the factor structure, and ME/I was assessed between treatment groups, informants, and time points. The criterion validity of the SDQ predictive algorithm for ADHD was compared with clinician and research diagnoses using logistic regression and tests of diagnostic accuracy. RESULTS: A 5-factor structure provided the best fit with strong factorial invariance between treatment groups and across time points, but not across informants (parent and teacher ratings). SDQ ratings of 'probable' hyperactivity disorder were good predictors of clinical (OR = 10.20, 95%CI 2.18-48.71,p = 0.003) and research diagnoses of ADHD (OR = 6.82, 95%CI 1.95-23.84,p = 0.003), and research diagnoses of Hyperkinetic disorder (OR = 4.02, 95%CI 1.13-14.25,p = 0.031). Further examination of the SDQ hyperactivity 'probable' rating showed good specificity (84.5%-74.5%) but poor sensitivity (45.0-42.5%) for ADHD. CONCLUSION: The findings indicate the SDQ is a valid outcome measure for use in RCTs and clinical settings. However, care should be taken when using the SDQ predictive algorithm to screen for ADHD in clinically referred samples.
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Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Autoavaliação Diagnóstica , Inquéritos e Questionários/normas , Adolescente , Criança , Feminino , Humanos , MasculinoRESUMO
BACKGROUND: Guidelines in the United Kingdom recommend that medication titration for attention deficit hyperactivity disorder (ADHD) should be completed within 4-6 weeks and include regular reviews. However, most clinicians think that weekly clinic contact is infeasible, and audits have shown that this timeline is rarely achieved. Thus, a more effective monitoring and review system is needed; remote monitoring technology (RMT) may be one way to improve current practice. However, little is known about whether patients with ADHD, their families, and clinicians would be interested in using RMT. OBJECTIVE: To explore patients', parents', and health care professionals' views and attitudes toward using digital technology for remote monitoring during titration for ADHD. METHODS: This was a qualitative study, and data were collected through 11 focus groups with adults and young people with ADHD, parents of children with ADHD, and health care professionals (N=59). RESULTS: All participant groups were positive about using RMT in the treatment of ADHD, but they were also aware of barriers to its use, especially around access to technology and integrating RMT into clinical care. They identified that RMT had the most potential for use in the ongoing management and support of ADHD, rather than during the distinct titration period. Participants identified features of RMT that could improve the quality of consultations and support greater self-management. CONCLUSIONS: RMT has the potential to augment support and care for ADHD, but it needs to go beyond the titration period and offer more to patients and families than monitoring through outcome measures. Developing and evaluating an mHealth app that incorporates the key features identified by end users is required.
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INTRODUCTION: The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current 'gold standard' ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome. METHODS AND ANALYSIS: This multisite randomised controlled trial will recruit young people (aged 6-17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice. ETHICS AND DISSEMINATION: The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval. TRIAL REGISTRATION NUMBER: NCT02209116.