RecruitingNot ApplicableNCT05142683

Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized Controlled Trial

Effectiveness of an Integrated Care Pathway for Adolescent Depression: A Quasi-experimental, Multi-site, Cluster Controlled Trial

Sponsor

Centre for Addiction and Mental Health

Enrollment

300 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

Summary

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 clinical outcome of interest is the difference between treatment groups in the rate of change of depressive symptoms from baseline to 24-week endpoint as measured by the Mood and Feelings Questionnaire. The secondary outcomes include rate of change of functional improvement, as measured by the Childhood Anxiety and Depression Life Interference Scale, and caregiver-rated internalizing symptoms as rated by the Childhood Behaviour Checklist. This study will also be examining implementation outcomes such as feasibility, fidelity cost and acceptability.

Eligibility

Min Age: 13 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an integrated care plan for depression in teenagers (ages 13–18) seen at healthcare clinics. Researchers want to find out if a structured care pathway leads to better outcomes than standard care for young people with depressive symptoms. **You may be eligible if...** - You are a young person aged 13–18 - Depression or low mood is a concern for you or your caregiver, and your clinician agrees it is a treatment priority - You score above a certain threshold on a depression questionnaire at two visits in a row - You are new to the clinic (within the past 3 months) or have had a gap in treatment of at least 3 months **You may NOT be eligible if...** - You have persistent psychotic symptoms that affect your daily functioning - You have severe bipolar disorder, psychosis, severe eating disorder, autism spectrum disorder with significant impairment, or are at immediate risk of suicide requiring hospitalization - You are currently in a day treatment program - You are not able to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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