{Reference Type}: Clinical Trial Protocol
{Title}: An Integrated Care Pathway for depression in adolescents: protocol for a Type 1 Hybrid Effectiveness-implementation, Non-randomized, Cluster Controlled Trial.
{Author}: Courtney DB;Barwick M;Amani B;Greenblatt AT;Aitken M;Krause KR;Andrade BF;Bennett K;Cleverley K;Uliaszek AA;de Oliveira C;Hawke LD;Henderson J;Wang W;Watson P;Gajaria A;Newton AS;Ameis S;Relihan J;Prebeg M;Chen S;Szatmari P;
{Journal}: BMC Psychiatry
{Volume}: 24
{Issue}: 1
{Year}: 2024 Mar 8
{Factor}: 4.144
{DOI}: 10.1186/s12888-023-05297-4
{Abstract}: <B>BACKGROUND: </B>Our group developed an Integrated Care Pathway to facilitate the delivery of evidence-based care for adolescents experiencing depression called CARIBOU-2 (Care for Adolescents who Receive Information 'Bout OUtcomes, 2nd iteration). The core pathway components are assessment, psychoeducation, psychotherapy options, medication options, caregiver support, measurement-based care team reviews and graduation. We aim to test the clinical and implementation effectiveness of the CARIBOU-2 pathway relative to treatment-as-usual (TAU) in community mental health settings.<BR><B>METHODS: </B>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.<BR><B>BACKGROUND: </B>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.