Integrated Care Pathway for Youth Depression

Depression Clinical Trial

— CARIBOU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03428555
• Other study ID #: 079/2017
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2018
• Est. completion date: February 21, 2020

Study information

• Verified date: August 2018
• Source: Centre for Addiction and Mental Health
• Contact: Darren B Courtney, MD
• Phone: 416-535-8501
• Email: darren.courtney[@]camh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 21, 2020
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Depression
• Depressive Disorder
• ICP1

Intervention

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
• 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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	The Center for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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