Mental DisordersNCT02836080
Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)
A study testing Integrated Collaborative Care Team (ICCT) and Treatment as Usual (TAU) in people with Mental Disorders and Addiction, run by Centre for Addiction and Mental Health at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Mental Disorders, Addiction
- What is being tested?
- Integrated Collaborative Care Team (ICCT) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 5 sitesCanada
- Study dates
- Sep 2016to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
North York General Hospital
Toronto, Ontario, M2K 1E1
Michael Garron Hospital
Toronto, Ontario, M4C 3E7
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, M6J 1H4
About this study
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
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.
Read the 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.
- Conditions
- Mental Disorders, Addiction
- Being tested
- Integrated Collaborative Care Team (ICCT), Treatment as Usual (TAU)
- Keywords
- Mental Health, Randomized, Pragmatic, Integrated Collaborative Care, Addiction, Youth
- Medical subject headings
- Mental Disorders, Behavior, Addictive, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Collaborative Care Team (ICCT)Behavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Collaborative Care Team | Experimental | 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. Receives: Behavioral: Integrated Collaborative Care Team (ICCT) |
| Treatment as Usual (TAU) | Active comparator | 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth functioning
Measured using the Columbia Impairment Scale (CIS)
Measured: One year
Secondary outcomes (9)
Clinical improvement
Measured using Strengths and Difficulties Questionnaire
Measured: One year
Problematic substance use
Assessed using the GAIN Short Screener and the substance use table of the Adolescent Alcohol and Drug Involvement Scale
Measured: One year
Satisfaction with the service models
Assessed using the Ontario Perception of Care Tool for Mental Health and Addictions
Measured: One year
Continuity of care
Measured using the Continuity of Care in Children's Mental Health questionnaire
Measured: One year
Goal attainment
Measured using a custom form indicating goals established by the youth and caregiver at intake, followed by a rating of goal attainment
Measured: One year
Client empowerment and engagement
Measured using the Family Empowerment Scale for caregivers, and the Youth Efficacy/Empowerment Scale for youth
Measured: One year
Caregiver burden
Measured using the Burden Assessment Scale
Measured: One year
Quality-adjusted life years (QALYs)
Measured using the Assessment of Quality of Life-6D (AQOL-6D)
Measured: One year
Cost-effective analysis (CEA) and a cost-utility analysis (CUA)
Incremental costs of ICCT compared to TAU (treatment as usual) in improving health outcomes
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2021
- Study completionApr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Joanna Henderson, Centre for Addiction and Mental Health
- Investigators
- Joanna Henderson, Ph.D., C.Psych, Principal investigator, 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 TorontoPeter Szatmari, MD, FRCPC, Principal investigator, 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 TorontoAmy Cheung, MD, FRCPC, Principal investigator, Associate Scientist, Evaluative Clinical Sciences, Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute; Associate Professor, Department of Psychiatry, University of TorontoKristin Cleverley, RN, Ph.D., Principal investigator, 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 HealthGloria Chaim, M.S.W., Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836080
- Sponsor's protocol ID
- #012/2016
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2016
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Quinlan-Davidson M, Henderson JL, Szatmari P, Cheung A, Dixon M, Relihan J, Singer D, Hawke LD, Cleverley K. A qualitative study exploring youth's experiences of hospital- and integrated community-based mental health services: the YouthCan IMPACT initiative. BMC Psychiatry. 2025 Nov 12;25(1):1084. doi: 10.1186/s12888-025-07523-7.
PubMed 41225406Henderson J, Szatmari P, Cleverley K, Ma C, Hawke LD, Cheung A, Relihan J, Dixon M, Quinlan-Davidson M, Moretti M, de Oliveira C, Lee A, Courtney DB, O'Brien D, McDonald H, Lemke K, Pignatiello T, Monga S, Kozloff N, Solomon L, Andrade BF, Barwick M, Charach A, Courey L, Darnay K, Kurdyak P, Lin E, Shan D. Integrated Collaborative Care for Youths With Mental Health and Substance Use Challenges: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e259565. doi: 10.1001/jamanetworkopen.2025.9565.
PubMed 40358950Krause KR, Lee A, Shan D, Cost KT, Hawke LD, Cheung AH, Cleverley K, de Oliveira C, Quinlan-Davidson M, Moretti ME, Henderson JL, Ma C, Szatmari P. Minimally important change on the Columbia Impairment Scale and Strengths and Difficulties Questionnaire in youths seeking mental healthcare. BMJ Ment Health. 2025 Jan 22;28(1):e301425. doi: 10.1136/bmjment-2024-301425.
PubMed 39848629Henderson 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.
PubMed 28167747
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02836080
- Acronym / sponsor ID
- #012/2016
- Conditions
- Mental Disorders, Addiction
- Keywords
- Mental Health, Randomized, Pragmatic, Integrated Collaborative Care, Addiction, Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- 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
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2026 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Collaborative Care Team | Experimental | Behavioral: Integrated Collaborative Care Team (ICCT)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. |
| Treatment as Usual (TAU) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Integrated Collaborative Care Team |
| 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. | Other | Treatment as Usual (TAU) |
Primary outcome
Youth functioning
Time frame: One year
Measured using the Columbia Impairment Scale (CIS)
9 secondary outcomes
Clinical improvement
Time frame: One year
Problematic substance use
Time frame: One year
Satisfaction with the service models
Time frame: One year
Continuity of care
Time frame: One year
Goal attainment
Time frame: One year
Client empowerment and engagement
Time frame: One year
Caregiver burden
Time frame: One year
Quality-adjusted life years (QALYs)
Time frame: One year
Cost-effective analysis (CEA) and a cost-utility analysis (CUA)
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Derived from this study: PubMed 41225406Quinlan-Davidson M, Henderson JL, Szatmari P, Cheung A, Dixon M, Relihan J, Singer D, Hawke LD, Cleverley K. A qualitative study exploring youth's experiences of hospital- and integrated community-based mental health services: the YouthCan IMPACT initiative. BMC Psychiatry. 2025 Nov 12;25(1):1084. doi: 10.1186/s12888-025-07523-7.
- Derived from this study: PubMed 40358950Henderson J, Szatmari P, Cleverley K, Ma C, Hawke LD, Cheung A, Relihan J, Dixon M, Quinlan-Davidson M, Moretti M, de Oliveira C, Lee A, Courtney DB, O'Brien D, McDonald H, Lemke K, Pignatiello T, Monga S, Kozloff N, Solomon L, Andrade BF, Barwick M, Charach A, Courey L, Darnay K, Kurdyak P, Lin E, Shan D. Integrated Collaborative Care for Youths With Mental Health and Substance Use Challenges: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e259565. doi: 10.1001/jamanetworkopen.2025.9565.
- Derived from this study: PubMed 39848629Krause KR, Lee A, Shan D, Cost KT, Hawke LD, Cheung AH, Cleverley K, de Oliveira C, Quinlan-Davidson M, Moretti ME, Henderson JL, Ma C, Szatmari P. Minimally important change on the Columbia Impairment Scale and Strengths and Difficulties Questionnaire in youths seeking mental healthcare. BMJ Ment Health. 2025 Jan 22;28(1):e301425. doi: 10.1136/bmjment-2024-301425.
- Derived from this study: PubMed 28167747Henderson 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.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospitalLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Henderson, Ph.D., C.Psych principal investigator
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
Peter Szatmari, MD, FRCPC principal investigator
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
Amy Cheung, MD, FRCPC principal investigator
Associate Scientist, Evaluative Clinical Sciences, Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute; Associate Professor, Department of Psychiatry, University of Toronto
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Collaborative Care Team (ICCT) and Treatment as Usual (TAU) in people with Mental Disorders and Addiction, run by Centre for Addiction and Mental Health at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth functioning (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02836080, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.