STADIA - STAndardised DIagnostic Assessment for children and adolescents with emotional difficulties: a multi-centre randomised controlled trial

Nottinghamshire Healthcare NHS Foundation Trust & University of Nottingham requires access to NHS England data for the purpose of the following research project: STADIA - STAndardised DIagnostic Assessment for children and adolescents with emotional difficulties: a multi-centre randomised controlled trial.

The STADIA Trial is investigating whether the use of a standardised diagnostic assessment at the point of referral receipt helps support the referral and assessment processes within the Child and Adolescent Mental Health Services (CAMHS) and helps clinicians identify emotional disorders in children and young people.

The STADIA team have obtained additional funding for an add-on study, to follow-up children for at least 36 months post-randomisation using routinely collected data obtained from NHS England data linkage for these 539 participants.

Initially, for the actual STADIA trial, the children follow-up was set to 18 months, however in carrying out the STADIA trial in 8 large NHS Trusts across England, the team are very mindful that over the past three years, there has been a huge increase in demand for and referrals to CAMHS, with lengthy delays in children and young people being seen (often waiting well over a year). Through obtaining linked routinely collected data (i.e. from 36 months post-randomisation onwards), the team will be able to investigate longer-term service-related outcomes, such as use of services, for the children in the trial.

The following is a summary of the research aims provided by Nottinghamshire Healthcare NHS Foundation Trust & University of Nottingham:

Is the STADIA trial intervention (completion of a Standardised Diagnostic Assessment tool at the point of referral into CAMHS) associated with a reduction in the likelihood of:

• Future referral to NHS mental health services?

• Presentation to A&E / general hospitals with self-harm?

• Hospital admissions?

The following NHS England Data will be accessed:

• Hospital Episode Statistics Admitted Patient Care (HES APC) – necessary because one of the studied outcomes is hospital admission. It is also required for Adverse Event (AE) Reporting,

• Emergency Care Data Set (ECDS) – necessary because one of the studied outcomes is presentation to A&E. It is also required for AE Reporting,

• Mental Health Services Data (MHSDS) – necessary because one of the studied outcomes is future referral to mental health services,

• CSDS (formerly CYPHSDS) – necessary to assess the contacts and referrals to community services related to mental health issues. It is also required for AE Reporting.

The level of the Data will be identifiable which is necessary to link the NHS England Data with data held by University of Nottingham.

The Data will be minimised as follows:

• Limited to a study cohort identified by University of Nottingham.

• Limited to data between August 2020 to March 2025.

Nottinghamshire Healthcare NHS Foundation Trust is the research sponsor and the joint controller with University of Nottingham as the organisations responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This is in the public interest as the population under analysis is identified as vulnerable and under-served groups. Those are children and young people with mental health difficulties who have been referred to secondary healthcare services. This study will provide additional knowledge about a group where little is known about long-term outcomes, particularly of services. Therefore, this research is carried out for achieving purposes in the area of public health and for the public interest.

The funding is provided by National Institute for Health and Care Research (NIHR). The funding is specifically for the trial described.

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

University of Nottingham is a processor acting under the instructions of Nottinghamshire Healthcare NHS Foundation Trust and the chief investigator from University of Nottingham. The Nottingham Clinical Trials Unit (NCTU) has led the trial recruitment, collected the trial data and stored it in a secure server. This trial data will be sent to the Nottingham Trusted Research Environment (TRE) to be linked with the electronic health records obtained from NHS England for the study population.

Microsoft Limited provides IT hosting services to University of Nottingham and will store the Data as contracted by University of Nottingham.

PPI is led by the parent co-applicant and peer researcher with lived experience of caring for a child who has used CAMHS (CE).

The project has a separate Parent Advisory Group Panel and Young Person Advisory Group Panel which each aim to meet regularly. Meetings are co-facilitated by the co-applicant PPI leads and another member of the study research team.

Participants have personal experience of CAMHS referrals and/or assessment processes and are able to provide valuable insights into key issues.

The Advisory Panels have actively contributed to all aspects of the research, including:

• Preparation of publicity materials to raise awareness of the study,

• Overseeing the wording of Participant Information Sheets,

• Advising on the wording of the feedback information from the DAWBA to participants and clinicians,

• Advising on outcomes to assess, including outcomes in the long-term data linkage study,

• Developing the health economic proforma,

• Designing the qualitative interview schedules,

• Facilitating qualitative interviews,

• Contributing to qualitative analysis workshops to discuss themes,

• Evaluating the findings, and prioritising and disseminating key findings.

University of Nottingham will transfer data to NHS England. The data will consist of identifying details (specifically Study ID, NHS Number and Date of Birth) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES APC, ECDS, MHSDS and CSDS datasets to University of Nottingham. The Data will contain directly identifying data items including NHS Number, Date of Birth, Postcode which are required to link the Data at record level with data already held by the recipient.

The Data will not be transferred to any other location.

The Data will be stored on the University of Nottingham Trusted Research Environment (TRE) servers hosted by Microsoft Limited.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations within the UK. The data will not leave the UK at any time.

Access is restricted to substantive employees of the University of Nottingham who have authorisation from the Chief Investigator (CI).

Nottinghamshire Healthcare NHS Foundation Trust and Microsoft Limited are not permitted to access the Data.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The data will also be linked with research data held by University of Nottingham.

Access to identifiable data will be restricted only to the allocated Research Fellow, Data Manager and University of Nottingham’s IT Support Team to carry out the pseudonymisation within the University of Nottingham’s TRE. Any other researcher from the University of Nottingham, supporting the analysis of the data will only access pseudonymised data. Where data has been pseudonymised, no attempt will be made by any organisation party to this Agreement to re-identify individuals included in the study population.

Identifiers will be stored in a separate protected folder within the TRE for the length of the Trial. However, at the end of the trial, the final datasets for the analysis and the identifiers will be sent to the NCTU and safely retained for 7 years as per the University policy. Clinical trial data as per the clinical trials regulations should be kept for a minimum of 5 years for an Investigational Medicinal Product (IMP) trial. The university policy is 7 years from the date of first publication.

Researchers from the University of Nottingham will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings to NIHR at the end of the project.

• Submissions to peer reviewed journals at the end of the project.

• Presentations to NIHR Mental Health Mission Translational Research Collaboration.

• Presentations at appropriate conferences.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Reports,

• Journals,

• Presentations,

• Press/media engagement,

• Website and Newsletters,

• Interactive dissemination workshop / consensus meeting,

• Focussed events for NHS providers, commissioners and training organisations,

• CAMHS Clinician Training,

Results will be published in high-impact peer reviewed journals and presented at medical/ mental health conferences locally, nationally, and internationally to disseminate the finding to research, scientific and medical community. In particular there will be engagement with scientific and policy-making communities to ensure that the knowledge developed through this research will benefit these communities.

To reach the relevant groups that could benefit from the results of this study, presentations will be organised to target audiences. The University of Nottingham will be targeting the clinical/health planning sector via conferences that have audiences in children and adolescents’ mental health.

The target date for production and dissemination of the outputs is at the end of the project with an estimated date for June 2026.

The results of this study will help assessing the effectiveness of the use of standardised diagnostic assessment (SDA) tool called the Development and Well-Being Assessment (DAWBA), that has been used in the STADIA trial.

The use of diagnostic assessments has been recommended so that important problems are detected and appropriate interventions are offered. Specifically, the NICE guidelines for depression recommend the use of standardised diagnostic assessment tools as potential adjuncts in addition to clinical assessments, in the detection of depression within CAMHS, to enable the allocation of cases to the most appropriate professional.

The introduction of an SDA tool at the point of referral to CAMHS could enable resources to be better targeted and lead to a more timely conclusion to assessments with a diagnostic decision, increase the probability that an appropriate evidence-based treatment is offered, and lead to improved outcomes (such as greater reduction of symptoms and improvement in functioning) from treatment as well as a better experience of care for the child and their families. However, there is limited evidence on the utility of SDA tools for informing optimal approaches to assessment within routine clinical practice.

There is therefore a need to better evaluate the use of SDA tools and to identify barriers to modifying diagnostic practice. Hence, this study will help evaluating the clinical effectiveness of an SDA tool, the Development and Well-Being Assessment (DAWBA), as an adjunct to clinical assessment in CAMHS, for children presenting with emotional difficulties.

Many vulnerable children and their families could benefit from the findings of this study that could help with identifying and treating child’s mental health difficulties more appropriately and promptly.

It is hoped that through publication of findings in appropriate media, the findings of this research will reach the relevant audience and provide support to the national guidelines to improve the treatment offered to the affected children. If this study finds an association between the DAWBA tool and a decrease in future referral to NHS mental health services, presentation to A&E / general hospitals with self-harm, hospital admissions due to mental/emotional disorders, the new tool could be under consideration in the next review of the national guidelines on this topic.

One of the PPIs group tasks is to evaluate the findings, and prioritising and disseminating key findings. Conferences and publications will target specific journals and relevant targets to make sure the findings will reach the wider audience with the aim to maximise the patients and public benefits. For the main STADIA trial, we have disseminated the findings through the Association for Child & Adolescent Mental Health (ACAMH) and the Royal College of Psychiatrists (RCPsych) and will do the same in relation to this additional work.

Yielded Benefits is not a requirement for new applications.