Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)
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|ClinicalTrials.gov Identifier: NCT02836080|
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : June 7, 2017
|Condition or disease||Intervention/treatment|
|Mental Disorders Addiction||Behavioral: Integrated Collaborative Care Team (ICCT) Other: Treatment as Usual (TAU)|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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 Start Date :||August 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
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.
Behavioral: Integrated Collaborative Care Team (ICCT)
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.
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.
Other: Treatment as Usual (TAU)
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.
- Youth functioning [ Time Frame: One year ]Measured using the Columbia Impairment Scale (CIS)
- Clinical improvement [ Time Frame: One year ]Measured using Strengths and Difficulties Questionnaire
- Problematic substance use [ Time Frame: One year ]Assessed using the GAIN Short Screener and the substance use table of the Adolescent Alcohol and Drug Involvement Scale
- Satisfaction with the service models [ Time Frame: One year ]Assessed using the Ontario Perception of Care Tool for Mental Health and Addictions
- Continuity of care [ Time Frame: One year ]Measured using the Continuity of Care in Children's Mental Health questionnaire
- Goal attainment [ Time Frame: One year ]Measured using a custom form indicating goals established by the youth and caregiver at intake, followed by a rating of goal attainment
- Client empowerment and engagement [ Time Frame: One year ]Measured using the Family Empowerment Scale for caregivers, and the Youth Efficacy/Empowerment Scale for youth
- Caregiver burden [ Time Frame: One year ]Measured using the Burden Assessment Scale
- Quality-adjusted life years (QALYs) [ Time Frame: One year ]Measured using the Assessment of Quality of Life-6D (AQOL-6D)
- Cost-effective analysis (CEA) and a cost-utility analysis (CUA) [ Time Frame: One year ]Incremental costs of ICCT compared to TAU (treatment as usual) in improving health outcomes
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836080
|Contact: Joanna Henderson, Ph.D., C.Psych||416-535-8501 ext email@example.com|
|Contact: Peter Szatmari, MD, FRCPC||416-813-7654 ext firstname.lastname@example.org|
|Michael Garron Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M4C 3E7|
|Contact: Krista Lemke, MD, FRCPC 416-469-6580 ext 3298 email@example.com|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Amy Cheung, MD, M.Sc., FRCPC 416-480-4073 firstname.lastname@example.org|
|The Hospital for Sick Children||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Antonio Pignatiello, MD, FRCPC 416-813-7524 email@example.com|
|Centre for Addiction and Mental Health (CAMH)||Recruiting|
|Toronto, Ontario, Canada, M6J 1H4|
|Contact: Joanna Henderson, Ph.D. 416-535-8501 ext 34959 firstname.lastname@example.org|
|Contact: Peter Szatmari, MD, FRCPC 416-813-7654 ext 328706 email@example.com|
|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|