Recipient organisationNottinghamshire Healthcare NHS Foundation TrustSource-published name: Nottinghamshire Healthcare NHS Foundation Trust
Funding£1.8M
PeriodNov 2018 — Jul 2026
In plain English
AI plain-English summary
A large-scale trial will test whether giving children and their families a standardised online diagnostic questionnaire before their first mental health appointment helps clinicians reach a faster, more accurate diagnosis of emotional disorders. Around one in eight children in the UK experiences an emotional disorder such as anxiety or depression, but diagnosis in Child and Adolescent Mental Health Services (CAMHS) can be slow and inconsistent. Clinicians often rely on unstructured interviews, which vary in quality and completeness. The trial will compare standard assessment with one that adds the Development and Well-Being Assessment (DAWBA), a structured tool completed by parents and children aged 11 and over, with results shared with both families and clinicians. If the tool proves effective, it could reduce the time from referral to diagnosis and treatment, improve consistency across NHS trusts, and help allocate limited CAMHS resources more efficiently. The study will also measure whether earlier diagnosis leads to better outcomes for mood, anxiety, behaviour, and quality of life, and whether the approach is cost-effective from a health and social care perspective. The trial involves 1,210 participants across five NHS sites and includes an internal pilot to check acceptability before full recruitment.
View original technical description
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.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know