CARIBOU-1: A pilot controlled trial of an Integrated Care Pathway for the treatment of depression in adolescents.

ABSTRACT

Background: To co-ordinate a multidisciplinary team in the delivery of guideline recommendations using a measurement-based care framework, our group previously developed a care pathway for the treatment of depression in adolescents. Core components of the pathway were assessment, education, cognitive-behavioural therapy, a caregiver intervention group, a medication algorithm, and monthly measurement-based care "team reviews" with the adolescent present. The aim of this study was to test the feasibility of conducting a controlled clinical trial of the pathway. Method: We conducted a 20-week pilot controlled clinical trial of the care pathway relative to treatment as usual. Participants were adolescents (age 14-18) with a primary diagnosis of Major Depressive Disorder recruited from one of two outpatient psychiatric clinics at academic hospitals. Site of presentation was the method of allocation. Thirty-five youth were allocated to the pathway and 31 were allocated to treatment as usual. As this is a pilot study, trial feasibility outcomes were of primary interest, including clinician fidelity to the care pathway. Results: Our target sample size was recruited over a 15-month time interval. Clinician fidelity and adolescent engagement in the care pathway components on a priori checklists were high (95% and 80%, respectively). We collected baseline and 20-week endpoint data for our primary outcome of the Children's Depression Rating Scale - Revised (CDRS-R) for 83% of the sample. On linear mixed effects modelling, we observed a linear decrease in CDRS-R across 4-week intervals up to the 20-week endpoint in both groups (ß = -2.07; 95% CI -3.14 to -1.01). Conclusion: A controlled clinical trial of a complex, multi-component intervention for the treatment of depression in adolescents is feasible. Given the need to find optimal strategies to deliver effective care for adolescents with depression, a definitive randomized controlled trial of the pathway is warranted.Trial is registered at Clinicaltrials.gov NCT03428555.