- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02836080
Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)
Integrated Collaborative Care Teams to Enhance Service Delivery to Youth With Mental Health and Substance Use Challenges: Protocol for a Pragmatic Randomized-controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a pragmatic randomized control trial (RCT) with random allocation occurring within each hospital site to either treatment as usual (TAU) (4 out-patient hospital sites) or treatment at one of 3 community-based Integrated Collaborative Care Teams (ICCTs). A total of 500 youth aged 14-18 with mental health and/or addictions (MHA) concerns, referred for out-patient services at one of four local hospitals, will be randomized to receive ICCT care versus TAU. For each youth, a primary caregiver will also be recruited into the study, if available.
With wide inclusion criteria and a design meant to emulate a "real world" setting, this study will rigorously evaluate a service delivery model composed of multiple interventions for youth presenting with a broad range of MHA problems. The ICCT is expected to result in better MHA outcomes, show better performance indicators, and be more cost-effective than TAU.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Toronto, Ontario, Canada, M2K 1E1
- North York General Hospital
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Toronto, Ontario, Canada, M4C 3E7
- Michael Garron Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Hospital
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Toronto, Ontario, Canada, M6J 1H4
- Centre for Addiction and Mental Health (CAMH)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Provision of informed consent
- Aged 14 - 17 years 11 months
- New referrals to one of the four participating hospitals for out-patient MHA services
- Among the population regularly accepted for out-patient services at that hospital
Exclusion Criteria:
- Referral for specialty forensic or firesetting treatment
- Moderate to severe intellectual disability or autism without MHA problems
- Primary diagnosis of an eating disorder
- Active psychosis or imminent risk of self-harm requiring immediate intervention
- Inability to read and write English or to consent to the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Integrated Collaborative Care Team
Integrated Collaborative Care Team (ICCTs) are housed in the local community to improve youth access, in three neighborhoods across Toronto (East Metro Youth Services [EMYS]-Scarborough, EMYS-Southeast Toronto, and Delisle Youth Services-Central Toronto).
Each ICCT will include a variety of service providers and coordinated patient care delivering evidence-informed interventions in a stepped-care model.
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An integrated, collaborative pathway of needs-based services.
ICCTs will offer a wide variety of services, including Solution-Focused Brief Therapy (SFBT) on a scheduled and walk-in basis, care navigators, various clinician-guided interventions, psychiatry, nurse practitioner services, access to primary care, and peer support, all co-located in youth-friendly, community-based clinics.
For each intervention, standardized intervention protocols will be used.
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Active Comparator: Treatment as Usual (TAU)
The comparator arm consists of out-patient TAU in a hospital setting and will occur at one of four outpatient hospital sites across Toronto. Partners include the following four hospitals: Hospital for Sick Children (SickKids), the Centre for Addiction and Mental Health (CAMH), Michael Garron Hospital (formerly the Toronto East General Hospital), and Sunnybrook Hospital. |
Standard out-patient treatment provided at each participating hospital site.
This typically entails referral to a psychiatrist at the participating hospital, who will provide assessment and treatment, with referral to appropriate services, guided by local treatment protocols.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Youth functioning
Time Frame: One year
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Measured using the Columbia Impairment Scale (CIS)
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical improvement
Time Frame: One year
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Measured using Strengths and Difficulties Questionnaire
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One year
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Problematic substance use
Time Frame: One year
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Assessed using the GAIN Short Screener and the substance use table of the Adolescent Alcohol and Drug Involvement Scale
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One year
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Satisfaction with the service models
Time Frame: One year
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Assessed using the Ontario Perception of Care Tool for Mental Health and Addictions
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One year
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Continuity of care
Time Frame: One year
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Measured using the Continuity of Care in Children's Mental Health questionnaire
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One year
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Goal attainment
Time Frame: One year
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Measured using a custom form indicating goals established by the youth and caregiver at intake, followed by a rating of goal attainment
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One year
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Client empowerment and engagement
Time Frame: One year
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Measured using the Family Empowerment Scale for caregivers, and the Youth Efficacy/Empowerment Scale for youth
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One year
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Caregiver burden
Time Frame: One year
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Measured using the Burden Assessment Scale
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One year
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Quality-adjusted life years (QALYs)
Time Frame: One year
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Measured using the Assessment of Quality of Life-6D (AQOL-6D)
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One year
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Cost-effective analysis (CEA) and a cost-utility analysis (CUA)
Time Frame: One year
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Incremental costs of ICCT compared to TAU (treatment as usual) in improving health outcomes
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One year
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Joanna Henderson, Ph.D., C.Psych, Director, Margaret and Wallace McCain Centre for Child, Youth and Family Mental Health; Clinician Scientist, Centre for Addiction and Mental Health; Associate Professor, Dept. of Psychiatry, University of Toronto
- Principal Investigator: Peter Szatmari, MD, FRCPC, Chief, Child and Youth Mental Health Collaborative, The Hospital for Sick Children and Centre for Addiction and Mental Health; Professor and Head of the Division of Child and Youth Mental Health, University of Toronto
- Principal Investigator: Amy Cheung, MD, FRCPC, Associate Scientist, Evaluative Clinical Sciences, Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute; Associate Professor, Department of Psychiatry, University of Toronto
- Principal Investigator: Kristin Cleverley, RN, Ph.D., CAMH Chair in Mental Health Nursing Research; Assistant Professor, University of Toronto; Clinician-Scientist, Margaret and Wallace McCain Centre for Child, Youth & Family Mental Health, Centre for Addiction and Mental Health
- Principal Investigator: Gloria Chaim, M.S.W., Associate Director, Child Youth and Family Services; Head, Community Engagement and Partnership, Margaret and Wallace McCain Centre for Child, Youth and Family Mental Health, CAMH; Assistant Professor, Dept. of Psychiatry, University of Toronto
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #012/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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