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Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)

Primary Purpose

Mental Disorders, Addiction

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Integrated Collaborative Care Team (ICCT)
Treatment as Usual (TAU)
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorders focused on measuring Mental Health, Randomized, Pragmatic, Integrated Collaborative Care, Addiction, Youth

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North York General Hospital
  • Michael Garron Hospital
  • Sunnybrook Hospital
  • The Hospital for Sick Children
  • Centre for Addiction and Mental Health (CAMH)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrated Collaborative Care Team

Treatment as Usual (TAU)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Youth functioning
Measured using the Columbia Impairment Scale (CIS)

Secondary Outcome Measures

Clinical improvement
Measured using Strengths and Difficulties Questionnaire
Problematic substance use
Assessed using the GAIN Short Screener and the substance use table of the Adolescent Alcohol and Drug Involvement Scale
Satisfaction with the service models
Assessed using the Ontario Perception of Care Tool for Mental Health and Addictions
Continuity of care
Measured using the Continuity of Care in Children's Mental Health questionnaire
Goal attainment
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
Measured using the Family Empowerment Scale for caregivers, and the Youth Efficacy/Empowerment Scale for youth
Caregiver burden
Measured using the Burden Assessment Scale
Quality-adjusted life years (QALYs)
Measured using the Assessment of Quality of Life-6D (AQOL-6D)
Cost-effective analysis (CEA) and a cost-utility analysis (CUA)
Incremental costs of ICCT compared to TAU (treatment as usual) in improving health outcomes

Full Information

First Posted
July 14, 2016
Last Updated
August 29, 2023
Sponsor
Centre for Addiction and Mental Health
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
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1. Study Identification

Unique Protocol Identification Number
NCT02836080
Brief Title
Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)
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 Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2016 (Actual)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Addiction
Keywords
Mental Health, Randomized, Pragmatic, Integrated Collaborative Care, Addiction, Youth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated Collaborative Care Team
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Collaborative Care Team (ICCT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Youth functioning
Description
Measured using the Columbia Impairment Scale (CIS)
Time Frame
One year
Secondary Outcome Measure Information:
Title
Clinical improvement
Description
Measured using Strengths and Difficulties Questionnaire
Time Frame
One year
Title
Problematic substance use
Description
Assessed using the GAIN Short Screener and the substance use table of the Adolescent Alcohol and Drug Involvement Scale
Time Frame
One year
Title
Satisfaction with the service models
Description
Assessed using the Ontario Perception of Care Tool for Mental Health and Addictions
Time Frame
One year
Title
Continuity of care
Description
Measured using the Continuity of Care in Children's Mental Health questionnaire
Time Frame
One year
Title
Goal attainment
Description
Measured using a custom form indicating goals established by the youth and caregiver at intake, followed by a rating of goal attainment
Time Frame
One year
Title
Client empowerment and engagement
Description
Measured using the Family Empowerment Scale for caregivers, and the Youth Efficacy/Empowerment Scale for youth
Time Frame
One year
Title
Caregiver burden
Description
Measured using the Burden Assessment Scale
Time Frame
One year
Title
Quality-adjusted life years (QALYs)
Description
Measured using the Assessment of Quality of Life-6D (AQOL-6D)
Time Frame
One year
Title
Cost-effective analysis (CEA) and a cost-utility analysis (CUA)
Description
Incremental costs of ICCT compared to TAU (treatment as usual) in improving health outcomes
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Henderson, Ph.D., C.Psych
Organizational Affiliation
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
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Szatmari, MD, FRCPC
Organizational Affiliation
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
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amy Cheung, MD, FRCPC
Organizational Affiliation
Associate Scientist, Evaluative Clinical Sciences, Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute; Associate Professor, Department of Psychiatry, University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristin Cleverley, RN, Ph.D.
Organizational Affiliation
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
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gloria Chaim, M.S.W.
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
North York General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 1E1
Country
Canada
Facility Name
Michael Garron Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
Sunnybrook Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Centre for Addiction and Mental Health (CAMH)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28167747
Citation
Henderson JL, Cheung A, Cleverley K, Chaim G, Moretti ME, de Oliveira C, Hawke LD, Willan AR, O'Brien D, Heffernan O, Herzog T, Courey L, McDonald H, Grant E, Szatmari P. Integrated collaborative care teams to enhance service delivery to youth with mental health and substance use challenges: protocol for a pragmatic randomised controlled trial. BMJ Open. 2017 Feb 6;7(2):e014080. doi: 10.1136/bmjopen-2016-014080.
Results Reference
derived
Links:
URL
http://www.camh.net/research
Description
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital

Learn more about this trial

Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)

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