跳至主要内容
临床试验/NCT02836080
NCT02836080进行中(未招募)不适用

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 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
247
试验地点
5
主要终点
Youth functioning

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Integrated Collaborative Care Team (ICCT) (Behavioral)

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.

干预措施: Treatment as Usual (TAU) (Other)

结局指标

主要结局

Youth functioning

时间窗: One year

Measured using the Columbia Impairment Scale (CIS)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

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

研究点 (5)

Loading locations...

相似试验