Protocol for the economic evaluation of the Care for Adolescents who Received Information 'Bout Outcomes, 2nd iteration (CARIBOU-2) non-randomised, cluster-controlled trial of an integrated care pathway for depression in adolescents.

INTRODUCTION

Depressive disorders in adolescents are highly prevalent and debilitating and are a risk factor for self-harm and death by suicide. In the context of recovery from the COVID-19 pandemic, strained healthcare resources are compounded by an increased demand for treatment services for adolescents with depression. The objective of this study protocol is to delineate the proposed economic evaluation of an integrated care pathway for depression in adolescents within the Care for Adolescents who Received Information 'Bout Outcomes, 2nd iteration (CARIBOU-2) non-randomised, cluster-controlled trial.

METHODS AND ANALYSIS

Two economic evaluations of the CARIBOU-2 trial (n=300) will be conducted-a cost-effectiveness analysis and a cost-utility analysis. In the cost-effectiveness analysis, we will examine the primary clinical outcome of the trial, change in the Mood and Feelings Questionnaire total score. In the cost-utility analysis, the clinical outcome will be quality-adjusted life-years, a generic measure of health burden. Data on the resources and respective costs required to deliver the intervention will be collected by the research team. Data on resource use post-intervention will be obtained from a mix of administrative data holdings and self-report; relevant unit costs will be obtained from existing data sources. The outcome of both economic evaluations will be the incremental cost-effectiveness ratio. Relevant sensitivity analyses will be undertaken, and cost-effectiveness acceptability curves will be produced to characterise any sources of uncertainty in the analysis. Equity considerations will also be examined, where relevant.

ETHICS AND DISSEMINATION

Ethical approval for the larger CARIBOU-2 trial, including the economic evaluation, has been obtained by the Centre for Addiction and Mental Health as well as site-level ethics boards (019/2021; Centre for Addiction and Mental Health). All participants will provide informed consent for their data to be analysed and reported. The results of the main trial and the economic evaluation will be submitted for publication in a peer-reviewed journal and shared with relevant policy makers across Canada.

TRIAL REGISTRATION NUMBER

NCT05142683.