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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
Sponsor:
Collaborators:
East Metro Youth Services
Delisle Youth Services
LOFT Community Services
The Sashbear Foundation
The Anne Johnston Health Station
South East Toronto Family Health Team
Institute for Clinical Evaluative Sciences
Medical Psychiatry Alliance
Graham Boeckh Foundation
The Ontario Spor Support Unit
Information provided by (Responsible Party):
Joanna Henderson, Centre for Addiction and Mental Health

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Among youth, the prevalence of mental health and addiction (MHA) disorders is roughly 20%, yet youth are challenged to access services in a timely fashion. To address MHA system gaps, this study will test the benefits of an Integrated Collaborative Care Team (ICCT) model for at-risk youth with MHA challenges. In partnership with community agencies, adolescent psychiatry hospital departments, and family health teams, investigators have developed an innovative model of service provision involving rapid access to MHA services. This model will be implemented and compared to the usual treatment youth receive in hospital-based, outpatient, mental health clinics in Toronto. A rapid, systematic, approach to MHA services geared to need in a youth-friendly environment is expected to result in better MHA outcomes for youth. Moreover, the ICCT approach is expected to decrease service wait-times, be more youth- and family-centred, and be more cost-effective.

Condition or disease Intervention/treatment Phase
Mental Disorders Addiction Behavioral: Integrated Collaborative Care Team (ICCT) Other: Treatment as Usual (TAU) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Youth functioning [ Time Frame: One year ]
    Measured using the Columbia Impairment Scale (CIS)


Secondary Outcome Measures :
  1. Clinical improvement [ Time Frame: One year ]
    Measured using Strengths and Difficulties Questionnaire

  2. 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

  3. Satisfaction with the service models [ Time Frame: One year ]
    Assessed using the Ontario Perception of Care Tool for Mental Health and Addictions

  4. Continuity of care [ Time Frame: One year ]
    Measured using the Continuity of Care in Children's Mental Health questionnaire

  5. 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

  6. Client empowerment and engagement [ Time Frame: One year ]
    Measured using the Family Empowerment Scale for caregivers, and the Youth Efficacy/Empowerment Scale for youth

  7. Caregiver burden [ Time Frame: One year ]
    Measured using the Burden Assessment Scale

  8. Quality-adjusted life years (QALYs) [ Time Frame: One year ]
    Measured using the Assessment of Quality of Life-6D (AQOL-6D)

  9. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent
  2. Aged 14 - 17 years 11 months
  3. New referrals to one of the four participating hospitals for out-patient MHA services
  4. Among the population regularly accepted for out-patient services at that hospital

Exclusion Criteria:

  1. Referral for specialty forensic or firesetting treatment
  2. Moderate to severe intellectual disability or autism without MHA problems
  3. Primary diagnosis of an eating disorder
  4. Active psychosis or imminent risk of self-harm requiring immediate intervention
  5. Inability to read and write English or to consent to the study
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Contact: Joanna Henderson, Ph.D., C.Psych 416-535-8501 ext 34959 joanna.henderson@camh.ca
Contact: Peter Szatmari, MD, FRCPC 416-813-7654 ext 328706 peter.szatmari@camh.ca

Locations
Canada, Ontario
Michael Garron Hospital Not yet recruiting
Toronto, Ontario, Canada, M4C 3E7
Contact: Krista Lemke, MD, FRCPC    416-469-6580 ext 3298    klemk@tegh.on.ca   
Sunnybrook Hospital Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Amy Cheung, MD, M.Sc., FRCPC    416-480-4073    amy.cheung@sunnybrook.ca   
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Antonio Pignatiello, MD, FRCPC    416-813-7524    antonio.pignatiello@sickkids.ca   
Centre for Addiction and Mental Health (CAMH) Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Joanna Henderson, Ph.D.    416-535-8501 ext 34959    joanna.henderson@camh.ca   
Contact: Peter Szatmari, MD, FRCPC    416-813-7654 ext 328706    peter.szatmari@camh.ca   
Sponsors and Collaborators
Centre for Addiction and Mental Health
East Metro Youth Services
Delisle Youth Services
LOFT Community Services
The Sashbear Foundation
The Anne Johnston Health Station
South East Toronto Family Health Team
Institute for Clinical Evaluative Sciences
Medical Psychiatry Alliance
Graham Boeckh Foundation
The Ontario Spor Support Unit
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joanna Henderson, Director, Margaret and Wallace McCain Centre for Child, Youth and Family Mental Health; Associate Professor of Psychiatry, University of Toronto, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02836080     History of Changes
Other Study ID Numbers: #012/2016
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Joanna Henderson, Centre for Addiction and Mental Health:
Mental Health
Randomized
Pragmatic
 Integrated Collaborative Care
Addiction
Youth

Additional relevant MeSH terms:
Behavior, Addictive
Mental Disorders
Psychotic Disorders
 Compulsive Behavior
Impulsive Behavior
Schizophrenia Spectrum and Other Psychotic Disorders