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STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial

Day, Florence; Wyatt, Laura; Bhardwaj, Anupam; Dubicka, Bernadka; Ewart, Colleen; Gledhill, Julia; James, Marilyn; Lang, Alexandra; Marshall, Tamsin; Montgomery, Alan; Reynolds, Shirley; Sprange, Kirsty; Thomson, Louise; Bradley, Ellen; Lathe, James; Newman, Kristina; Partlett, Chris; Starr, Kath; Sayal, Kapil


Florence Day

Clinical Trial Manager

Anupam Bhardwaj

Bernadka Dubicka

Colleen Ewart

Julia Gledhill

Professor of Health Economics

Tamsin Marshall

Director, nottingham Clinical Trials Unit

Shirley Reynolds

James Lathe

Kristina Newman

Assistant Professor of Medical Statistics and Clinical Trials

Kath Starr

Professor of Child and Adolescent Psychiatry


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.


Day, F., Wyatt, L., Bhardwaj, A., Dubicka, B., Ewart, C., Gledhill, J., …Sayal, K. (2022). STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial. BMJ Open, 12(5), Article e053043.

Journal Article Type Article
Acceptance Date Mar 17, 2022
Online Publication Date May 11, 2022
Publication Date May 11, 2022
Deposit Date Jul 22, 2022
Publicly Available Date Jul 22, 2022
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 12
Issue 5
Article Number e053043
Public URL
Publisher URL


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