Integrated Care Pathway for Youth Depression (CARIBOU)

Is an Integrated Care Pathway for Adolescents With Depression More Effective Than Treatment as Usual? A Controlled Clinical Trial

Major Depressive Disorder in adolescence is prevalent and debilitating. Our group aims to improve treatment response through the use of an Integrated Care Pathway (ICP) based on a high quality Clinical Practice Guideline and measurement-based care (MBC; where periodic symptom scale scores are used to make treatment decisions). We propose a controlled clinical trial comparing ICP to treatment-as-usual (TAU) across two sites.

Study Overview

• Status: Unknown
• Conditions: Depression; Adolescent Behavior; ICP1
• Intervention / Treatment: Behavioral: Integrated Care Pathway; Behavioral: Treatment As Usual

Detailed Description

Background: There is a gap between what is known from the evidence about the treatment of adolescent depression and what is practiced. Moreover, while there is evidence that measurement-based care can improve outcomes for adults with various mental health conditions, there is limited information on this framework in adolescent depression.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4Y 3M5
      • Not yet recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Amy Cheung, MD; Phone Number: 4164804073; Email: amy.cheung@sunnybrook.ca
      • Contact: Michelle Li, BA; Phone Number: 4164804073; Email: michelle.li@sunnybrook.ca
    • Toronto, Ontario, Canada, M6J 1H4
      • Recruiting
      • The Center for Addiction and Mental Health
      • Contact: Darren B Courtney, MD; Phone Number: 30539 416-535-8501; Email: darren.courtney@camh.ca
      • Contact: Susan Dickens, MA; Phone Number: 416-535-8501; Email: susan.dickens@camh.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Psychiatrist's impression is that depression is a primary psychiatric. concern
• 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:

• Threshold psychotic symptoms.
• Bipolar disorder.
• Moderate-to-severe substance use disorder.
• Autistic spectrum disorder or intellectual disability.
• Eating disorder.
• Suicide-related behaviours requiring acute intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrate Care Pathway; The intervention is an Integrated Care Pathway with 3 key components.; 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.; Provider engagement: The clinicians at CAMH reviewed the template and collaboratively developed a flow chart defining the treatment protocol.; 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).	Behavioral: 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
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Childhood Depression Rating Scale-Revised scores	The CDRS-R is a 17-item measure rated by an evaluator after a semi-structured interview with the adolescent relating to symptoms of depression over the past 2 weeks. Scores range from 0 to 100 with a score of over 55 interpreted as a moderate to severe rating. Lower values represent a better outcome.	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in WHO Disability Assessment Schedule 2.0 for Children And Youth	Change in function as reported by participant The sum of scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Lower values represent a decrease in their subjective depression rating over the previous 2 weeks.	20 weeks
Change in Childhood Behaviour Checklist	Change in overall psychopathology as reported by caregiver.Total scores may be computed for Social Competence, Behavior Problems, Internalizing Problems, and Externalizing Problems, plus scores for each of the 8 syndrome scales. Raw scores are converted to age-standardized scores (T-Scores). T scores less than 67 are considered in the normal range, T scores ranging from 67-70 are considered to be borderline clinical, and T scores above 70 are in the clinical range.	20 weeks

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Collaborators: Sunnybrook Health Sciences Centre
• Investigators: Study Director: Peter Szatmari, MD, The Center for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Anticipated): August 29, 2019
• Study Completion (Anticipated): February 21, 2020

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 079/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No