Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02836080|
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mental Disorders Addiction||Behavioral: Integrated Collaborative Care Team (ICCT) Other: Treatment as Usual (TAU)||Not Applicable|
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 2020|
|Estimated Study Completion Date :||June 2020|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836080
|Contact: Joanna Henderson, Ph.D., C.Psych||416-535-8501 ext firstname.lastname@example.org|
|Contact: Peter Szatmari, MD, FRCPC||416-813-7654 ext email@example.com|
|North York General Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M2K 1E1|
|Contact: Leigh Solomon, MD|
|Michael Garron Hospital||Recruiting|
|Toronto, Ontario, Canada, M4C 3E7|
|Contact: Krista Lemke, MD, FRCPC 416-469-6580 ext 3298 firstname.lastname@example.org|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Amy Cheung, MD, M.Sc., FRCPC 416-480-4073 email@example.com|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Antonio Pignatiello, MD, FRCPC 416-813-7524 firstname.lastname@example.org|
|Centre for Addiction and Mental Health (CAMH)||Recruiting|
|Toronto, Ontario, Canada, M6J 1H4|
|Contact: Joanna Henderson, Ph.D. 416-535-8501 ext 34959 email@example.com|
|Contact: Peter Szatmari, MD, FRCPC 416-813-7654 ext 328706 firstname.lastname@example.org|
|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|