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Clinical Trials/NCT02836080
NCT02836080
Active, Not Recruiting
N/A

Integrated Collaborative Care Teams to Enhance Service Delivery to Youth With Mental Health and Substance Use Challenges: Protocol for a Pragmatic Randomized-controlled Trial

Centre for Addiction and Mental Health5 sites in 1 country247 target enrollmentSeptember 1, 2016

Overview

Phase
N/A
Intervention
Integrated Collaborative Care Team (ICCT)
Conditions
Mental Disorders
Sponsor
Centre for Addiction and Mental Health
Enrollment
247
Locations
5
Primary Endpoint
Youth functioning
Status
Active, Not Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2016
End Date
April 1, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

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

Arms & Interventions

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.

Intervention: Integrated Collaborative Care Team (ICCT)

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.

Intervention: Treatment as Usual (TAU)

Outcomes

Primary Outcomes

Youth functioning

Time Frame: One year

Measured using the Columbia Impairment Scale (CIS)

Secondary Outcomes

  • Satisfaction with the service models(One year)
  • Client empowerment and engagement(One year)
  • Quality-adjusted life years (QALYs)(One year)
  • Caregiver burden(One year)
  • Clinical improvement(One year)
  • Problematic substance use(One year)
  • Continuity of care(One year)
  • Goal attainment(One year)
  • Cost-effective analysis (CEA) and a cost-utility analysis (CUA)(One year)

Study Sites (5)

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