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UnknownNCT03428555

Integrated Care Pathway for Youth Depression

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Centre for Addiction and Mental Health · Academic / Other
Sex
All
Age
14 Years – 18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALIntegrated Care PathwayThe 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
BEHAVIORALTreatment As UsualTreatment 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.

Timeline

Start date
2018-03-29
Primary completion
2019-08-29
Completion
2020-02-21
First posted
2018-02-09
Last updated
2018-08-09

Locations

2 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT03428555. Inclusion in this directory is not an endorsement.