Clinical trial NCT02836080: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Disorders
Addiction
Keywords: Mental Health
Randomized
Pragmatic
Integrated Collaborative Care
Addiction
Youth
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: East Metro Youth Services
name: Delisle Youth Services
name: LOFT Community Services
name: The Sashbear Foundation
name: The Anne Johnston Health Station
name: South East Toronto Family Health Team
name: Institute for Clinical Evaluative Sciences
name: Medical Psychiatry Alliance
name: Graham Boeckh Foundation
name: The Ontario Spor Support Unit
First posted: 2016-07-18
Enrollment: 247
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Youth functioning
timeFrame: One year
Secondary outcomes:
measure: Clinical improvement
timeFrame: One year
measure: Problematic substance use
timeFrame: One year
measure: Satisfaction with the service models
timeFrame: One year
measure: Continuity of care
timeFrame: One year
measure: Goal attainment
timeFrame: One year
measure: Client empowerment and engagement
timeFrame: One year
measure: Caregiver burden
timeFrame: One year
measure: Quality-adjusted life years (QALYs)
timeFrame: One year
measure: Cost-effective analysis (CEA) and a cost-utility analysis (CUA)
timeFrame: One year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Michael Garron Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health (CAMH)
state: Ontario
Study officials:
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
name: Joanna Henderson, Ph.D., C.Psych
role: PRINCIPAL_INVESTIGATOR
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
name: Peter Szatmari, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Scientist, Evaluative Clinical Sciences, Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute; Associate Professor, Department of Psychiatry, University of Toronto
name: Amy Cheung, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
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
name: Kristin Cleverley, RN, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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
name: Gloria Chaim, M.S.W.
role: PRINCIPAL_INVESTIGATOR
References:
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.