Article Text

Protocol
STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial
  1. Florence Day1,
  2. Laura Wyatt1,
  3. Anupam Bhardwaj2,
  4. Bernadka Dubicka3,4,
  5. Colleen Ewart5,
  6. Julia Gledhill6,
  7. Marilyn James1,
  8. Alexandra Lang7,
  9. Tamsin Marshall8,
  10. Alan Montgomery1,
  11. Shirley Reynolds9,
  12. Kirsty Sprange1,
  13. Louise Thomson10,
  14. Ellen Bradley10,
  15. James Lathe1,
  16. Kristina Newman11,
  17. Chris Partlett1,
  18. Kath Starr1,
  19. Kapil Sayal10,11
  1. 1 Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK
  2. 2 Cambridgeshire and Peterborough NHS Foundation Trust, Fulbourn, UK
  3. 3 Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK
  4. 4 Pennine Care NHS Foundation Trust, Ashton-under-Lyne, UK
  5. 5 STADIA Patient and Public Involvement co-lead, Institute of Mental Health, University of Nottingham, Nottingham, UK
  6. 6 Central and North West London NHS Foundation Trust, London, UK
  7. 7 Faculty of Engineering, University of Nottingham, Nottingham, UK
  8. 8 Berkshire Healthcare NHS Foundation Trust, Bracknell, UK
  9. 9 School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK
  10. 10 Unit of Mental Health & Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK
  11. 11 Institute of Mental Health, Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK
  1. Correspondence to Professor Kapil Sayal; kapil.sayal{at}nottingham.ac.uk

Abstract

Introduction Emotional disorders (such as anxiety and depression) are associated with considerable distress and impairment in day-to-day function for affected children and young people and for their families. Effective evidence-based interventions are available but require appropriate identification of difficulties to enable timely access to services. Standardised diagnostic assessment (SDA) tools may aid in the detection of emotional disorders, but there is limited evidence on the utility of SDA tools in routine care and equipoise among professionals about their clinical value.

Methods and analysis A multicentre, two-arm, parallel group randomised controlled trial, with embedded qualitative and health economic components. Participants will be randomised in a 1:1 ratio to either the Development and Well-Being Assessment SDA tool as an adjunct to usual clinical care, or usual care only. A total of 1210 participants (children and young people referred to outpatient, specialist Child and Adolescent Mental Health Services with emotional difficulties and their parent/carers) will be recruited from at least 6 sites in England. The primary outcome is a clinician-made diagnosis about the presence of an emotional disorder within 12 months of randomisation. Secondary outcomes include referral acceptance, diagnosis and treatment of emotional disorders, symptoms of emotional difficulties and comorbid disorders and associated functional impairment.

Ethics and dissemination The study received favourable opinion from the South Birmingham Research Ethics Committee (Ref. 19/WM/0133). Results of this trial will be reported to the funder and published in full in the Health Technology Assessment (HTA) Journal series and also submitted for publication in a peer reviewed journal.

Trial registration number ISRCTN15748675; Pre-results.

  • child & adolescent psychiatry
  • depression & mood disorders
  • health economics
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Footnotes

  • FD and LW are joint first authors.

  • Contributors FD, LW, AB, BD, CE, JG, MJ, AL, TM, AM, SR, KSp, LT, EB, JL, KN, CP, KSt and KSa made substantial contributions to conception and design or acquisition of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work. KSa is guarantor for the paper. FD and LW contributed equally to this paper.

  • Funding This study was funded as a result of a commissioned call by the National Institute for Health Research (NIHR) Health Technology Assessment programme (Grant Reference Number 16/96/09).

  • Disclaimer The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The funder will have no role in the collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.