Clinical trial NCT05142683: Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized Controlled Trial
Official title: Effectiveness of an Integrated Care Pathway for Adolescent Depression: A Quasi-experimental, Multi-site, Cluster Controlled Trial (Edited on March 7th, 2024)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Adolescents
Integrated Care Pathway
Depression
Measurement Based Care
Implementation
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: The Hospital for Sick Children
First posted: 2021-12-02
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study uses a Type 1 Hybrid Implementation Effectiveness design that focuses on the effectiveness of the clinical intervention (ICP) while exploring the implementation effectiveness of the intervention.

A stepped wedge, cluster randomized controlled trial is indicated as the intervention is applied at the clinic level.

Edited on March 7th, 2024: The study uses a Type 1 Hybrid Implementation Effectiveness design that focuses on the effectiveness of the clinical intervention (ICP) while exploring the implementation effectiveness of the intervention.

A cluster controlled trial is indicated as the intervention is applied at the clinic-level.
Primary purpose: TREATMENT

Brief summary: This a stepped wedged cluster RCT 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 objective is to establish the clinical effectiveness of the ICP intervention in the community setting relative to TAU, with respect to reducing evaluator-rated depressive symptoms. The secondary objectives are to explore changes in clinician-rated function and caregiver-rated symptoms for youth receiving the ICP intervention relative to TAU. The third objective is to explore the implementation effectiveness of the ICP intervention, namely investigating: feasibility, fidelity, cost and acceptability.

Edited on March 7th, 2024: 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 objective is to establish the clinical effectiveness of the ICP intervention in the community setting relative to TAU, with respect to reducing evaluator-rated depressive symptoms. The secondary objectives are to explore changes in clinician-rated function and caregiver-rated symptoms for youth receiving the ICP intervention relative to TAU. The third objective is to explore the implementation effectiveness of the ICP intervention in the community setting, namely investigating: feasibility, fidelity, cost and acceptability.

Detailed description: Background: Depression is the leading cause of disability in adolescents and a potent risk factor for adolescent 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 adolescent depression in community setting relative to typical care.

Objective: The current study aim is to test the effectiveness of an ICP for depression in adolescents, called the CARIBOU-2 intervention, versus treatment-as-usual (TAU) in community settings. We hypothesize that participants receiving the ICP will show greater clinical improvement (in symptoms and functioning) than participants in TAU. This study will also examine important implementation outcomes.

Method: The primary participants will be adolescents (N= 648), between the ages of 13 to 18 with depressive symptoms, presenting to one of six selected community mental health agencies. Through a stepped wedge design, all sites will begin in the TAU condition and transition to the ICP condition in a randomized sequence. 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 Childhood Depression Rating Scale-Revised. Secondary outcomes include rate of change of functional improvement, as measured by the Children's Global Assessment Scale, and caregiver-rated internalizing symptoms as rated by the Childhood Behaviour Checklist.

Generalized linear mixed-effects model is a proper choice to test our clinical hypotheses to control for covariates (e.g. demographics and baseline clinical measures), to accommodate multiple forms of the outcome (e.g. continuous, categorical and count type), and to account for clustering at individual level (for repeated measures) and at site level. Time, stage 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 quadratic or piecewise models when the linear model may not be adequate. We will adopt the intention-to-treat approach in general and use multiple imputation methods as the primary missing data strategy.

Count data, proportions and qualitative data will be used to describe implementation outcomes.

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

Edited on March 7th, 2024

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 will be adolescents (N= 300 ), between the ages of 13 to 18 with depressive symptoms, presenting to one of six selected community mental health agencies. Through a quasi-experimental, multi-site cluster controlled clinical trial design, sites will begin in the TAU condition and transition to the ICP condition once local enrollment to TAU has reached 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 Childhood Depression Rating Scale-Revised. Secondary outcomes include rate of change of functional improvement, as measured by the Children's Global Assessment 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.

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 in the community with regards to improvement of depressive symptoms (Hypothesis A), self-reported functioning (Hypothesis B), caregiver-reported internalizing psychopathology (Hypothesis C), and suicidal ideation and behaviours (exploratory). Generalized linear mixed-effects model is a proper choice to control for covariates (e.g. demographics and baseline clinical measures), to accommodate multiple forms of the outcome (e.g. continuous, categorical and count type), and to account for clustering at individual level (for repeated measures) and at site level. 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.

Count data, proportions and qualitative data will be used to describe implementation outcomes.

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

Eligibility criteria: 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

Primary outcomes:
measure: Childhood Depression Rating Scale-Revised
timeFrame: Change from baseline to 24 weeks
Secondary outcomes:
measure: Columbia Suicide Severity Rating Scale
timeFrame: Change from baseline to 24 weeks
measure: Depression Rating Scale
timeFrame: Change from baseline to 24 weeks
measure: Youth Quality of Life Scale Research Version
timeFrame: Change from baseline to 24 weeks
measure: Health and Social Service Utilization
timeFrame: Change from baseline to 24 weeks
measure: Ontario Perception of Care Tool for Mental Health and Addictions
timeFrame: Change from baseline to 24 weeks
measure: Adolescent Alcohol and Drug Involvement Scale Grid
timeFrame: Change from baseline to 24 weeks
measure: Cognitive Behavioural Therapy Skills Questionnaire
timeFrame: Change from baseline to 24 weeks
measure: CollaboRATE
timeFrame: Change from baseline to 24 weeks
measure: Nonsuicidal Self-Injury
timeFrame: Change from baseline to 24 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: University of Toronto
name: Darren B Courtney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bennett K, Courtney D, Duda S, Henderson J, Szatmari P. An appraisal of the trustworthiness of practice guidelines for depression and anxiety in children and youth. Depress Anxiety. 2018 Jun;35(6):530-540. doi: 10.1002/da.22752. Epub 2018 Apr 26.
citation: Courtney D, Bennett K, Henderson J, Darnay K, Battaglia M, Strauss J, Watson P, Szatmari P. A Way through the woods: Development of an integrated care pathway for adolescents with depression. Early Interv Psychiatry. 2020 Aug;14(4):486-494. doi: 10.1111/eip.12918. Epub 2019 Dec 27.
citation: Courtney DB, Bennett K, Szatmari P. The Forest and the Trees: Evidence-Based Medicine in the Age of Information. J Am Acad Child Adolesc Psychiatry. 2019 Jan;58(1):8-15. doi: 10.1016/j.jaac.2018.06.035.
citation: Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.