METHODS: We will use a Type 1 Hybrid Effectiveness-Implementation, Non-randomized Cluster Controlled Trial Design. Primary participants will be adolescents (planned n = 300, aged 13-18 years) with depressive symptoms, presenting to one of six community mental health agencies. All sites will begin in the TAU condition and transition to the CARIBOU-2 intervention after enrolling 25 adolescents. The primary clinical outcome is the rate of change of depressive symptoms from baseline to the 24-week endpoint using the Childhood Depression Rating Scale-Revised (CDRS-R). Generalized mixed effects modelling will be conducted to compare this outcome between intervention types. Our primary hypothesis is that there will be a greater rate of reduction in depressive symptoms in the group receiving the CARIBOU-2 intervention relative to TAU over 24 weeks as per the CDRS-R. Implementation outcomes will also be examined, including clinician fidelity to the pathway and its components, and cost-effectiveness.
BACKGROUND: Research ethics board approvals have been obtained. Should our results support our hypotheses, systematic implementation of the CARIBOU-2 intervention in other community mental health agencies would be indicated.
方法:我们将使用1型混合有效性-实施,非随机集群对照试验设计。主要参与者将是有抑郁症状的青少年(计划n=300,年龄13-18岁),向六个社区精神卫生机构之一介绍。所有站点将在TAU条件下开始,并在招募25名青少年后过渡到CARIBOU-2干预。主要临床结果是使用儿童抑郁量表修订(CDRS-R)的抑郁症状从基线到24周终点的变化率。将进行广义混合效应建模,以比较干预类型之间的结果。我们的主要假设是,根据CDRS-R,接受CARIBOU-2干预的组的抑郁症状相对于TAU在24周内的减少率更高。还将审查执行结果,包括临床医生对通路及其组成部分的忠诚,和成本效益。
背景:已获得研究伦理委员会的批准。如果我们的结果支持我们的假设,将指出在其他社区精神卫生机构中系统地实施CARIBOU-2干预措施。