Title: STAndardised DIagnostic Assessment for children and adolescents with emotional difficulties (STADIA): a multi-centre randomised controlled trial
Funder: Department of Health and Social Care

Abstract: DESIGN: Two-arm, parallel-group randomised controlled trial of an Standardised Diagnostic Assessment (SDA) tool plus assessment as usual compared with assessment as usual, with a nested qualitative study (internal pilot phase) and process evaluation (main trial). SETTING: Outpatient CAMHS (national spread of 5 sites within NHS Trusts in London, Berkshire, Cambridgeshire, East Midlands and the North-West). TARGET POPULATION: 5-17 year olds presenting with emotional difficulties referred to outpatient multidisciplinary specialist CAMHS. HEALTH TECHNOLOGIES BEING ASSESSED: Standardised diagnostic assessment tool (the DAWBA – Development & Well-Being Assessment) completed by the parent (and child, if aged 11+) with the results fed back to participants and clinical staff, as an adjunct to usual clinical practice (assessment as usual). MEASUREMENT OF COSTS AND OUTCOMES: Primary Outcome - Clinician diagnosis decision about the presence of an emotional disorder (either confirmed yes or confirmed no / uncertain, within 12 months of randomisation), collected from clinical records. Secondary outcomes include acceptance of referral (y/n), confirmed diagnosis decision (y/n), time to diagnosis, treatment offered for diagnosed disorder (y/n) and time to treatment. Therapeutic improvement will be assessed using specific and global clinically relevant outcome measures of mood, anxiety, behavioural problems, social function, and child and parent quality of life. Health Economics - Resource use associated with the intervention; direct and indirect health, social care and education sector costs. The health economic analysis will be conducted primarily from a health and social care perspective. The resource use data and subsequent calculation of health service and societal cost will be combined with outcome and child and carer quality of life data to provide a measure of the cost effectiveness and cost utility of the use of the SDA tool versus usual care. SAMPLE SIZE: To detect a difference of 55% vs. 45% (data obtained from trial sites) with 90% power and 5% two-sided alpha, requires 544 participants per arm for analysis. Allowing for up to 10% non-collection of the primary outcome, we will aim to randomise a total of 1210 participants. TIMETABLE: Months 1-6: Protocol development, approvals, database development, training. Months 7-15: Internal pilot recruitment. Milestone Month 15: Assessment of pre-determined acceptability and recruitment stop/go criteria. Months 16-30: Full recruitment. Milestone Month 42: End of full study follow-up. Months 43-48: Analysis and write-up. EXPERTISE IN TEAM: The trial will be led by a multi-disciplinary team with expertise in designing and successfully conducting clinical trials in child and adolescent mental health. The team consists of national experts in child and adolescent emotional disorders, medical statistics, trial management and delivery, health economics, healthcare technology, qualitative research and implementation research, with patient and public involvement from a parent co-applicant supported by the NIHR MindTech Healthcare Technology Co-operative.

Lay abstract: Background: This research focuses on children and adolescents with significant levels of emotional difficulties (such as anxiety or depression) who have been referred to Child and Adolescent Mental Health Services (CAMHS) for specialist help. These difficulties cause distress and have a major impact on their and others’ day-to-day lives. In the long run, these children may experience ongoing mental health problems, self-harm, poor physical health, family conflict, and problems with schooling, friendships and taking part in wider activities, potentially impacting into adulthood. Unfortunately, referrals are sometimes turned down by CAMHS and, even if the referral is accepted, assessments are often carried out without reaching a clinical diagnosis. This is important because many children and adolescents either do not get any help or help that is specifically tailored to their needs. Receiving the correct diagnosis is vital so that appropriate care and interventions can be offered. However, we do not know whether routinely using standard approaches to assessments in CAMHS makes a difference in terms of receiving a diagnosis and getting the right help. Aims and Research Design: We want to find out whether the use of a standard information-gathering package, so that the same information is collected about all children, helps with the assessment and diagnosis process in CAMHS. Children and adolescents with emotional difficulties who are referred to CAMHS (across different parts of England) will be randomly selected to go into one of two groups. For one group, the referral will be looked at and, if accepted, the assessment will be carried out as per usual practice. For the other group, the proposed package will be tested. This involves information being collected from the parent (and the child, if aged 11 or above) soon after the referral is received but before any decision has been made about accepting the referral. This information will then be passed on to the clinicians making this decision and, if the referral is accepted, also to the clinician carrying out the first assessment meeting with the family. We will assess how effective and cost-effective this approach is by seeing whether it makes any difference to whether or not a diagnosis is made and whether this better helps children and their families. We will follow the children up for 12 months to assess the impact on their emotional difficulties, day-to-day functioning and quality of life. Patient and Public Involvement: We have consulted with young people and parents and, if funded, will actively work alongside advisory groups of young people and parents in developing and carrying out the study. One member of our team is a parent with lived experience of seeking help for her child. PPI representatives within the study will be trained and supported throughout by our NIHR MindTech Involvement team. Dissemination and Outputs: For children and their families, receiving the right help at the right time can make a huge difference to their lives. Currently, the NHS has limited information about whether standard assessment approaches can help these children and their parents. By evaluating different approaches to assessment within CAMHS, and publicising our findings, our research will help improve care and inform clinical guidelines. Our findings will help the NHS decide how best to ensure value for money for how emotional difficulties are diagnosed.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: MENTAL HEALTH