Actively Recruiting
Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized Controlled Trial
Led by Centre for Addiction and Mental Health · Updated on 2024-03-22
300
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
Sponsors
C
Centre for Addiction and Mental Health
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This a stepped wedged cluster RCT 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 objective is to establish the clinical effectiveness of the ICP intervention in the community setting relative to TAU, with respect to reducing evaluator-rated depressive symptoms. The secondary objectives are to explore changes in clinician-rated function and caregiver-rated symptoms for youth receiving the ICP intervention relative to TAU. The third objective is to explore the implementation effectiveness of the ICP intervention, namely investigating: feasibility, fidelity, cost and acceptability. Edited on March 7th, 2024: 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 objective is to establish the clinical effectiveness of the ICP intervention in the community setting relative to TAU, with respect to reducing evaluator-rated depressive symptoms. The secondary objectives are to explore changes in clinician-rated function and caregiver-rated symptoms for youth receiving the ICP intervention relative to TAU. The third objective is to explore the implementation effectiveness of the ICP intervention in the community setting, namely investigating: feasibility, fidelity, cost and acceptability.
CONDITIONS
Official Title
Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Youth is aged 13 to 18 years, inclusive.
- Youth and/or their caregiver is expressing that 'depression' (or some synonym) is a concern.
- Clinician agrees that depressive symptoms are a treatment target.
- Mood and Feelings Questionnaire score is 622 at two sequential visits (screening and baseline assessment).
- Youth must be new to the site (in past 3 months) or have a period of no treatment for 3 months
You will not qualify if you...
- Known or highly suspected presentations of psychotic symptoms that are persistent, affect functioning, and have observable effects on behaviour.
- Severe substance use disorder, bipolar disorder, autism spectrum disorder or intellectual disability, severe eating disorder, imminent risk of suicide requiring hospitalization as per judgment of the assessing clinician.
- Inability to provide informed consent to the study for any reason.
- Youth currently in Day Treatment.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Actively Recruiting
Research Team
M
Michelle U Ferreira, MEd
CONTACT
B
Bahar Amani, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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