Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized Controlled Trial

Effectiveness of an Integrated Care Pathway for Adolescent Depression: A Quasi-experimental, Multi-site, Cluster Controlled Trial

This is a quasi-experimental, multi-site cluster controlled clinical trial design with two intervention arms--Treatment As Usual (TAU) and an Integrated Care Pathway (ICP). Eligible participants are between the ages of 13 and 18, who present to community mental health agencies with depressive symptoms as the primary concern. The primary clinical outcome of interest is the difference between treatment groups in the rate of change of depressive symptoms from baseline to 24-week endpoint as measured by the Mood and Feelings Questionnaire. The secondary outcomes include rate of change of functional improvement, as measured by the Childhood Anxiety and Depression Life Interference Scale, and caregiver-rated internalizing symptoms as rated by the Childhood Behaviour Checklist. This study will also be examining implementation outcomes such as feasibility, fidelity cost and acceptability.

Background: Depression is the leading cause of disability in adolescents and a potent risk factor for suicide. Evidence-based treatments are available; however, many clinics do not provide guidelines-based treatments. Integrated Care Pathways (ICPs) are treatment algorithms based on the highest quality practice guidelines intended to facilitate the delivery of evidence-based treatment at the clinic level. Our group has already tested the feasibility of ICP for adolescent depression at an academic setting. There is still uncertainty regarding whether ICPs lead to improved outcomes in depression in adolescents in community settings relative to typical care.

Objective: The current study aim is to test the effectiveness of an ICP for depression in adolescence, called the CARIBOU-2 intervention, versus treatment-as-usual (TAU) in community settings. This study will also examine important implementation outcomes.

Method: The primary participants are adolescents (Up to N=150), between the ages of 13 to 18 with depressive symptoms, presenting to one of the participating sites. Through a quasi-experimental, multi-site cluster controlled clinical trial design, sites began in the TAU condition and transitioned to the ICP condition once local enrollment to TAU has reached up to 25 participants. The primary clinical outcome of interest is the difference between treatment groups in the rate of change of depressive symptoms from baseline to 24-week endpoint as measured by the Mood and Feelings Questionnaire. Secondary outcomes include rate of change of functional improvement, as measured by the Childhood Anxiety and Depression Life Interference Scale, and caregiver-rated internalizing symptoms as rated by the Childhood Behaviour Checklist. This study will also be examining the following implementation outcomes: feasibility, fidelity cost and acceptability. Implementation will also be assessed at three additional sites through a light-touch evaluation conducted several months after training and implementation of the pathway, focusing on clinicians' perspectives and experiences.

Statistical Analyses:

Descriptive data analysis will be first conducted to examine distribution of collected measures and evaluate whether there are significant differences across arms of assigned sites. Generalized linear mixed-effects model will be the primary analytic tool for evaluating whether the CARIBOU-2 intervention is more effective than TAU for adolescents with depression presenting to care with regards to improvement of depressive symptoms, self-reported functioning, caregiver-reported internalizing psychopathology, and suicidal ideation and behaviours. Time, treatment assignment and their interactions will serve as the primary predictors for the analyses. As an example, if we let Y_ijt to denote a continuous outcome of the j-th participant of the i-th site measured at time t, a linear model for Y_ijt will look like the following:

Y_ijt=β_0+〖b_(0,ij)+b_(1,i)+β〗_1 t+β_2 〖Group〗_(i,t)+β_3 Group_it*t+〖β_4 X_ijt+ϵ〗_ijt

of which 〖Group〗_(i,t) denotes the treatment assignment of the i-th site at time t, X_ijt, additional covariates, b_(0,ij) and b_(1,i), random effects at individual and site levels respectively, ϵ_( ijt), unexplained random error, and β's, regression coefficients. For sensitivity analyses, we will explore the use of the piecewise model to model the time trend differently. We will adopt the intention-to-treat approach in general and use multiple imputation methods as the primary missing data strategy. In our pilot study, we have collected ~85% of expected longitudinal data points on the MFQ (primary clinical outcome), adjusting for attrition. Sensitivity analysis will be conducted to evaluate the impact of non-random missing and robust regression method will be used instead when the impact is high. SAS 9.4 will be our go-to software package for this project.

Relevance: Should our results be consistent with our hypotheses, systematic implementation of the CARIBOU-2 intervention to other community mental health agencies and hospitals would be indicated.

Inclusion Criteria:

• Youth is aged 13 to 18 years, inclusive.
• Youth and/or their caregiver is expressing that 'depression" (or some synonym) is a concern.
• Clinician agrees that depressive symptoms are a treatment target.
• Mood and Feelings Questionnaire score is ≥22 at two sequential visits (screening and baseline assessment).
• Youth must be new to the site (in past 3 months) or have a period of no treatment for 3 months

Exclusion Criteria:

• Known or highly suspected presentations of psychotic symptoms that are persistent, affect functioning, and have observable effects on behaviour.
• Severe substance use disorder, bipolar disorder, autism spectrum disorder or intellectual disability, severe eating disorder, imminent risk of suicide requiring hospitalization as per judgment of the assessing clinician.
• Inability to provide informed consent to the study for any reason
• Youth currently in Day Treatment