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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02836080
Other study ID # #012/2016
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date April 2025

Study information

Verified date August 2023
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 247
Est. completion date April 2025
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group 14 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Canada Centre for Addiction and Mental Health (CAMH) Toronto Ontario
Canada Michael Garron Hospital Toronto Ontario
Canada North York General Hospital Toronto Ontario
Canada Sunnybrook Hospital Toronto Ontario
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (11)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health Delisle Youth Services, East Metro Youth Services, Graham Boeckh Foundation, Institute for Clinical Evaluative Sciences, LOFT Community Services, Medical Psychiatry Alliance, South East Toronto Family Health Team, The Anne Johnston Health Station, The Ontario Spor Support Unit, The Sashbear Foundation

Country where clinical trial is conducted

Canada, 

Outcome

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