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

Study acronym: CARIBOU-2
StatusRecruiting
PhaseNot applicable
Started2022-02-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Centre for Addiction and Mental Health

Amendment history

2026-08-18
Study Status, Outcome Measures, IPDSharing v3
Primary endpoint(s) modified1 entry, revised
WasThe Mood and Feelings Questionnaire child, long version (MFQ; Angold & Costello, 1987)
NowThe Mood and Feelings Questionnaire (MFQ) child, long version
Secondary endpoints11 entries, revised
The Child Behaviour Checklist (CBCL) - Parent Report Form (CBCL; Achenbach, 2001) Clinical Global Impression Scale - both the Improvement Subscale (CGI-I) and Severity Subscale (CGI-S) (Busner & Targum, 2007)
2026-08-11
Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Contacts/Locations, IPDSharing, Document Section v2
Primary endpoint(s) modified1 entry, revised
WasChildhood Depression Rating Scale-Revised
NowThe Mood and Feelings Questionnaire child, long version (MFQ; Angold & Costello, 1987)
Secondary endpoints9 to 11 entries
The Child Behaviour Checklist - Parent Report Form (CBCL; Achenbach, 2001) Clinical Global Impression Scale - both the Improvement Subscale (CGI-I) and Severity Subscale (CGI-S) (Busner & Targum, 2007)
Study description-3,073 characters
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 h [...] Background: Depression is the leading cause of disability in [...] t implementation outcomes. Method: The primary participants will beare adolescents (Up to N= 300 150), between the ages of 13 to 18 with depressive symptoms, presenting to one of sixthe selectedparticipating community mental health agencies [...]
Study sitescontacts updated at 1 of 1 site
2024-03-20
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-09-30→2027-09-30
Completion date2025-09-30→2027-09-30
Start dateestimated 2022-01-04→confirmed 2022-02-01
Enrollment target648→300
Study sites0→1
Eligibility criteria-16 characters
[...] iver is expressing that 'depression" (or some synonym) is a primary concern. Clinician agrees that depressive symptoms are a primary treatment target. Mood and Feelings Questionnaire score is ≥ [...]
Secondary endpoints2 to 9 entries
Children'sColumbia GlobalSuicide AssessmentSeverity Rating Scale ChildDepression Behaviour Checklist - Internalizing BroadbandRating Scale Youth Quality of Life Scale Research Version Health and Social Service Utilization Ontario Perception of Care Tool for Mental Health and Addictions Adolescent Alcohol and Drug Involvement Scale Grid Cognitive Behavioural Therapy Skills Questionnaire CollaboRATE Nonsuicidal Self-Injury
Study description+3,828 characters
[...] tive 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 [...] Relevance: Should our results be consistent with our hypothe [...]
2021-12-01
Original filing
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.
Trial Details
NCT Number NCT05142683
Lead Sponsor Centre for Addiction and Mental Health
Collaborators: Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children
Conditions Major Depressive Disorder
Enrollment 300 participants
Start Date 2022-02-01
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-20