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      Integrated collaborative care teams to enhance service delivery to youth with mental health and substance use challenges: protocol for a pragmatic randomised controlled trial

      protocol

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          Abstract

          Introduction

          Among youth, the prevalence of mental health and addiction (MHA) disorders is roughly 20%, yet youth are challenged to access evidence-based services in a timely fashion. To address MHA system gaps, this study tests the benefits of an Integrated Collaborative Care Team (ICCT) model for youth with MHA challenges. A rapid, stepped-care approach geared to need in a youth-friendly environment is expected to result in better youth MHA outcomes. Moreover, the ICCT approach is expected to decrease service wait-times, be more youth-friendly and family-friendly, and be more cost-effective, providing substantial public health benefits.

          Methods and analysis

          In partnership with four community agencies, four adolescent psychiatry hospital departments, youth and family members with lived experience of MHA service use, and other stakeholders, we have developed an innovative model of collaborative, community-based service provision involving rapid access to needs-based MHA services. A total of 500 youth presenting for hospital-based, outpatient psychiatric service will be randomised to ICCT services or hospital-based treatment as usual, following a pragmatic randomised controlled trial design. The primary outcome variable will be the youth's functioning, assessed at intake, 6 months and 12 months. Secondary outcomes will include clinical change, youth/family satisfaction and perception of care, empowerment, engagement and the incremental cost-effectiveness ratio (ICER). Intent-to-treat analyses will be used on repeated-measures data, along with cost-effectiveness and cost-utility analyses, to determine intervention effectiveness.

          Ethics and dissemination

          Research Ethics Board approval has been received from the Centre for Addiction and Mental Health, as well as institutional ethical approval from participating community sites. This study will be conducted according to Good Clinical Practice guidelines. Participants will provide informed consent prior to study participation and data confidentiality will be ensured. A data safety monitoring panel will monitor the study. Results will be disseminated through community and peer-reviewed academic channels.

          Trial registration number

          Clinicaltrials.gov NCT02836080.

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          Most cited references22

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          Failure and delay in initial treatment contact after first onset of mental disorders in the National Comorbidity Survey Replication.

          An understudied crucial step in the help-seeking process is making prompt initial contact with a treatment provider after first onset of a mental disorder. To provide data on patterns and predictors of failure and delay in making initial treatment contact after first onset of a mental disorder in the United States from the recently completed National Comorbidity Survey Replication. Nationally representative face-to-face household survey carried out between February 2001 and April 2003. A total of 9282 respondents aged 18 years and older. Lifetime DSM-IV disorders were assessed with the World Mental Health (WMH) Survey Initiative version of the World Health Organization Composite International Diagnostic Interview (WMH-CIDI), a fully structured interview designed to be administered by trained lay interviewers. Information about age of first professional treatment contact for each lifetime DSM-IV/WMH-CIDI disorder assessed in the survey was collected and compared with age at onset of the disorder to study typical duration of delay. Cumulative lifetime probability curves show that the vast majority of people with lifetime disorders eventually make treatment contact, although more so for mood (88.1%-94.2%) disorders than for anxiety (27.3%-95.3%), impulse control (33.9%-51.8%), or substance (52.7%-76.9%) disorders. Delay among those who eventually make treatment contact ranges from 6 to 8 years for mood disorders and 9 to 23 years for anxiety disorders. Failure to make initial treatment contact and delay among those who eventually make treatment contact are both associated with early age of onset, being in an older cohort, and a number of socio-demographic characteristics (male, married, poorly educated, racial/ethnic minority). Failure to make prompt initial treatment contact is a pervasive aspect of unmet need for mental health care in the United States. Interventions to speed initial treatment contact are likely to reduce the burdens and hazards of untreated mental disorder.
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            Development and validation of the GAIN Short Screener (GSS) for internalizing, externalizing and substance use disorders and crime/violence problems among adolescents and adults.

            The Global Appraisal of Individual Needs (GAIN)1 is a 1-2 hour standardized biopsychosocial that integrates clinical and research assessment for people presenting to substance abuse treatment. The GAIN - Short Screener (GSS) is 3-5 minute screener to quickly identify those who would have a disorder based on the full 60-120 minute GAIN and triage the problem and kind of intervention they are likely to need along four dimensions (internalizing disorders, externalizing disorders, substance disorders, and crime/violence). Data were collected from 6,177 adolescents and 1,805 adults as part of 77 studies in three dozen locations around the United States that used the GAIN. For both adolescents and adults the 20-item total disorder screener (TDScr) and its four 5-item sub-screeners (internalizing disorders, externalizing disorders, substance disorders, and crime/violence) has good internal consistency (alpha of .96 on total screener), is highly correlated (r = .84 to .94) with the 123-item longer scales in the full GAIN. The GSS also does well in terms of its receiver operator characteristics (90% or more under the curve in all analyses) and has clinical decision-making cut points with excellent sensitivity (90% or more) for identifying people with a disorder and excellent specificity (92% or more) for correctly ruling out people who did not have a disorder. The GSS has good potential as an efficient screener for identifying people with co-occurring disorders across multiple systems and routing them to the right services and more detailed assessments.
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              Methods to explain the clinical significance of health status measures.

              One can classify ways to establish the interpretability of quality-of-life measures as anchor based or distribution based. Anchor-based measures require an independent standard or anchor that is itself interpretable and at least moderately correlated with the instrument being explored. One can further classify anchor-based approaches into population-focused and individual-focused measures. Population-focused approaches are analogous to construct validation and rely on multiple anchors that frame an individual's response in terms of the entire population (eg, a group of patients with a score of 40 has a mortality of 20%). Anchors for population-based approaches include status on a single item, diagnosis, symptoms, disease severity, and response to treatment. Individual-focused approaches are analogous to criterion validation. These methods, which rely on a single anchor and establish a minimum important difference in change in score, require 2 steps. The first step establishes the smallest change in score that patients consider, on average, to be important (the minimum important difference). The second step estimates the proportion of patients who have achieved that minimum important difference. Anchors for the individual-focused approach include global ratings of change within patients and global ratings of differences between patients. Distribution-based methods rely on expressing an effect in terms of the underlying distribution of results. Investigators may express effects in terms of between-person standard deviation units, within-person standard deviation units, and the standard error of measurement. No single approach to interpretability is perfect. Use of multiple strategies is likely to enhance the interpretability of any particular instrument.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2017
                6 February 2017
                : 7
                : 2
                : e014080
                Affiliations
                [1 ]Centre for Addiction and Mental Health (CAMH) , Toronto, Ontario, Canada
                [2 ]Sunnybrook Health Sciences Centre , Toronto, Ontario, Canada
                [3 ]Bloomberg Faculty of Nursing, University of Toronto , Toronto, Ontario, Canada
                [4 ]Clinical Trials Unit, The Hospital for Sick Children , Toronto, Ontario, Canada
                [5 ]SickKids Research Institute, Hospital for Sick Children , Toronto, Ontario, Canada
                [6 ]East Metro Youth Services , Scarborough, Ontario, Canada
                [7 ]Sashbear Foundation , Toronto, Ontario, Canada
                [8 ]LOFT Community Services, Toronto, Ontario, Canada
                [9 ]Youth and Families, Toronto, Ontario, Canada
                Author notes
                [Correspondence to ] Dr Joanna L Henderson; joanna.henderson@ 123456camh.ca
                Author information
                http://orcid.org/0000-0002-9387-5193
                Article
                bmjopen-2016-014080
                10.1136/bmjopen-2016-014080
                5293997
                28167747
                9adf23f4-cf02-4c45-b8c5-d9a986da6e15
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                : 30 August 2016
                : 29 November 2016
                : 5 January 2017
                Categories
                Mental Health
                Protocol
                1506
                1712
                1704
                1681
                1694
                1701

                Medicine
                mental health,youth
                Medicine
                mental health, youth

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