Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-03-29
2020-02-21
Brief Summary
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Detailed Description
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Objective: Our study aims to enhance the implementation of evidence-based care (using the NICE Clinical Practice Guidelines as a template) combined wtih measurement-based care through the use of an Integrated Care Pathway (ICP) in adolescents with depression.
Hypothesis: As this is a pilot study, our hypotheses centre around feasibility. We hypothesize that: (1) we will recruit at least 30 participants to the ICP treatment arm and 30 participants at the "treatment-as-usual" arm at a different site (2) that baseline measures will be fully completed by 95% of adolescents recruited, (3) that baseline measures will take 2 hours to complete for adolescents and 1 hour to complete for caregivers, (4) that a mean of 90% of the key aspects of the treatment protocol are followed in the ICP group (5) that 80% of participants recruited will complete measures at the end of the 20-week interval and that (6) 90% of the youth, caregivers and clinicians who partake int eh study will attend a focus group to provide qualitative feedback on their experience.
Design: This is a non-randomized controlled clinical trial. Randomizing at the individual level is not possible - the intervention is implemented at the clinic level; so the effect of the intervention on one youth within a clinic would influence the care of other youth at the clinic.
Sampling: Participants are recruited from psychiatric clinics at 2 sites. Each site will recruit to their respective treatment arm.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Integrate Care Pathway
The intervention is an Integrated Care Pathway with 3 key components.
1. Clinical Practice Guidelines (CPG) recommendations: The initial template of the treatment protocol was based on the NICE CPGs for Depression in Children and Young People.
2. Provider engagement: The clinicians at CAMH reviewed the template and collaboratively developed a flow chart defining the treatment protocol.
3. Measurement-based care: Feedback measures are taken every four weeks and the results are provided to the clinician, patient and family to inform treatment decisions. The feedback measures are the Mood and Feelings Questionnaire, the Columbia Impairment Scale (CIS) and the General Functioning Domain of the McMaster Family Assessment Device (MFAD).
Integrated Care Pathway
The intervention is a integrated care pathway based on the NICE Clinical Practice Guidelines and measurement-based care in the form of a flow chart. Each decision point on the pathway is guided by results of self-report measures for depression (the Mood and Feelings Questionnaire), functional impairment (Columbia Impairment Scales) and family functioning (the McMaster Family Assessment Device). The results of these scales and protocol recommendations are fed back to the patients, families and clinicians in order to make further treatment decisions
Treatment As Usual
Treatment As Usual : Participants at SHSC will receive treatment at could include a psychiatric evaluation, possible medication management and various types of psychotherapy, including cognitive-behavioural therapy, interpersonal psychotherapy, psychodynamic psychotherapy and family therapy. There is no structured protocol and no systematic Measurement Based Care. A research assistant will record the interventions received in either group via chart review.
Treatment As Usual
Treatment As Usual represents what clinicians would typically do when presented with an adolescent with depression. There is no algorithm provided to guide clinical decision-making and no systematic measurement-based care.
Interventions
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Integrated Care Pathway
The intervention is a integrated care pathway based on the NICE Clinical Practice Guidelines and measurement-based care in the form of a flow chart. Each decision point on the pathway is guided by results of self-report measures for depression (the Mood and Feelings Questionnaire), functional impairment (Columbia Impairment Scales) and family functioning (the McMaster Family Assessment Device). The results of these scales and protocol recommendations are fed back to the patients, families and clinicians in order to make further treatment decisions
Treatment As Usual
Treatment As Usual represents what clinicians would typically do when presented with an adolescent with depression. There is no algorithm provided to guide clinical decision-making and no systematic measurement-based care.
Eligibility Criteria
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Inclusion Criteria
* 14-18 years old.
* DSM-5 criteria for Major Depressive Disorder or Persistent Depressive Disorder as per the Diagnostic Interview for Affective Symptoms for Children (DIAS-C19).
* Speak, read and write English at a grade 6 level.
Exclusion Criteria
* Bipolar disorder.
* Moderate-to-severe substance use disorder.
* Autistic spectrum disorder or intellectual disability.
* Eating disorder.
* Suicide-related behaviours requiring acute intervention.
14 Years
18 Years
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Centre for Addiction and Mental Health
OTHER
Responsible Party
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Darren Courtney
Principle Investigator
Principal Investigators
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Peter Szatmari, MD
Role: STUDY_DIRECTOR
The Center for Addiction and Mental Health
Locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
The Center for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Courtney DB, Cheung A, Henderson J, Bennett K, Wang W, Chen S, Battaglia M, Strauss J, Mitchell R, Wang K, Relihan J, Prebeg M, Darnay K, Szatmari P. CARIBOU-1: A pilot controlled trial of an Integrated Care Pathway for the treatment of depression in adolescents. JCPP Adv. 2022 May 27;2(2):e12083. doi: 10.1002/jcv2.12083. eCollection 2022 Jun.
Other Identifiers
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079/2017
Identifier Type: -
Identifier Source: org_study_id
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