Effectiveness of an Integrated Care Pathway for Adolescents with Depression: A Pilot Clinical Trial Protocol

Our group aims to improve treatment response for adolescents with depression through the use of an Integrated Care Pathway (ICP) we developed using: (1) recommendations from a high quality Clinical Practice Guideline (CPG); and, (2) a measurement-based care framework.

Pre-specified criteria will identify eligible adolescents in two outpatient hospital study sites. Study group allocation, to the ICP versus treatment as usual (TAU), is based on site of presentation. The primary clinical outcome is reduction of depression symptoms, assessed using the Childhood Depression Rating Scale - Revised (CDRS-R). Measures will be taken at baseline and every four weeks until 20 weeks of treatment has been offered.

Our overall hypothesis is that the ICP will be associated with greater improvement in depressive symptoms compared to TAU. Feasibility targets for this pilot trial include the following: recruitment of 30 participants per site over a 21-month period, 95% baseline assessment completion rates, 90% clinician adherence to the ICP in the intervention arm and 80% completion of the scheduled CDRS-R measures over the 20-week interval. Focus-group feedback from youth and parents will also produce qualitative information.

If feasibility targets are met, and preliminary results regarding clinical outcomes are promising, then a multi-center cluster RCT would be pursued.