Clinical and cost-effectiveness of a standardised diagnostic assessment for children and adolescents with emotional difficulties: the STADIA multi-centre RCT.

Background: Emotional disorders are common in children and young people and can significantly impair their quality of life. Evidence-based treatments require a timely and appropriate diagnosis. The utility of standardised diagnostic assessment tools may aid the detection of emotional disorders, but there is limited evidence of their clinical value. Objectives: To assess the clinical effectiveness and cost effectiveness of a standardised diagnostic assessment for children and young people with emotional difficulties referred to Child and Adolescent Mental Health Services. A nested qualitative process evaluation aimed to identify the barriers and facilitators to using a standardised diagnostic assessment tool in Child and Adolescent Mental Health Services. Design: A United Kingdom, multicentre, two-arm, parallel-group randomised controlled trial with a nested qualitative process evaluation. Setting: Eight National Health Service Trusts providing multidisciplinary specialist Child and Adolescent Mental Health Services. Participants: Children and young people aged 5-17 years with emotional difficulties referred to Child and Adolescent Mental Health Services, excluding emergency/urgent referrals that required an expedited assessment. In the qualitative process evaluation, 15 young people aged 16-17 years, 38 parents/carers and 56 healthcare professionals participated in semistructured interviews. Interventions: Participants were randomly assigned (1 : 1) following referral receipt to intervention (the development and well-being assessment) and usual care, or usual care only. Main outcome measures: Primary outcome was a clinician-made diagnosis decision about the presence of an emotional disorder within 12 months of randomisation, collected from Child and Adolescent Mental Health Services clinical records. Secondary outcomes collected from clinical records included referral acceptance, time to offer and start treatment/interventions and discharge. Data were also self-reported from participants through online questionnaires at baseline, 6 and 12 months post randomisation, and the cost effectiveness of the intervention was investigated. Results: One thousand two hundred and twenty-five (1225) children and young people were randomly assigned (1 : 1) to study groups between 27 August 2019 and 17 October 2021; 615 were assigned to the intervention and 610 were assigned to the control group. Adherence to the intervention (full/partial completion of the development and well-being assessment) was 80% (494/615). At 12 months, 68 (11%) participants in the intervention group received an emotional disorder diagnosis versus 72 (12%) in the control group [adjusted risk ratio 0.94 (95% confidence interval 0.70 to 1.28); p = 0.71]. Child and Adolescent Mental Health Services acceptance of the index referral [intervention 277 (45%) vs. control 262 (43%); risk ratio: 1.06 (95% confidence interval: 0.94 to 1.19)] or any referral by 18 months [intervention 374 (61%) vs. control 352 (58%); risk ratio: 1.06 (95% confidence interval: 0.97 to 1.16)] was similar between groups. There was no evidence of any differences between groups for any other secondary outcomes. The qualitative nested process evaluation identified a number of barriers and facilitators to the use of the development and well-being assessment during the trial, particularly at the assessment and diagnosis stages of the Child and Adolescent Mental Health Services pathway. Limitations: It was not possible to mask participants, clinicians or site researchers collecting source data to treatment allocation. Conclusions: We found no evidence that completion of the development and well-being assessment aided the detection of emotional disorders in this study. Using the development and well-being assessment in this way cannot be recommended for clinical practice. Future research: To determine longer-term service use outcomes and to investigate whether receipt of a clinical diagnosis makes a difference to clinical outcomes and care/intervention receipt. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/96/09.