Clinical trial NCT04249960: Sustain and Reinforce the Transition From Child to Adult Mental Health Care in Switzerland : A Monocentric Nested Cohort Randomized Controlled Trial: The SORT Study.
Official title: Sustain and Reinforce the Transition From Child to Adult Mental Health Care in Switzerland : A Monocentric Nested Cohort Randomized Controlled Trial: The SORT Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychiatric Disorder
Transition
Keywords: adolescents
psychiatric disorders
CAMHS
AMHS
transition
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Disruption of care during transition from child and adolescent mental health (CAMHS) to adult mental health services (AMHS) may adversely affect the health and well-being of service users. Indeed, transition-related discontinuity of care is a major health and societal challenge today. Current evidences show that this transition is not always properly managed and that improving the transition process can have a positive impact on the health and wellbeing of young people. Nevertheless, data available are still inconsistent and only few studies investigated possible models aimed at improving and operationalize the transition. At present, no information concerning the transition in the Geneva Canton is available.

According to this lack of evidence, the current study aims at: 1) mapping the CAMHS/AMHS interface; 2) evaluating the longitudinal course and outcomes of adolescents approaching the transition boundary (TB) of their CAMHS; 3) determining the effectiveness of an experimental model of managed transition in improving outcomes, compared with usual care; 4) comparing these results with those of the EU funded MILESTONE study from several other European countries.

The investigators will recruit all patients aged ≥ 16 years and 6 months from the Geneva Canton in charge at CAMHS and they will follow them for up to 24 months. CAMHS will be instructed to provide all their service users at the time of transition either usual care or a novel service called "Managed Transition", which will include the use of a new decision support tool, the Transition Readiness and Appropriateness Measure (TRAM). A nested cohort Randomised Controlled Trial (ncRCT) design will be applied to divide patients into the two groups. The health and wellbeing of the young people will be assessed at baseline and then followed-up for 24 months to see whether they transition to AMHS or are discharged or referred to some other service. The investigators will then evaluate what impact the different transition experiences have on young people's health and wellbeing, and whether the process of Managed Transition has any benefits as compared to usual care.


Eligibility criteria: Inclusion Criteria:

* 1) provides valid written informed consent, or assent, if below the legal age of consent;
* 2) age is within 18 months of reaching the transition boundary of their CAMHS - during the trial recruitment period;
* 3) has a mental disorder defined by DSM-IV-TR, DSM-5 or ICD 10/11, or is under the regular care of CAMHS (if not yet diagnosed);
* 4) Has an IQ ≥ 70 as ascertained by previous standardized assessment or diagnosed by clinician, or no indication of intellectual impairment.

Exclusion Criteria:

* 1) does not provide valid written informed consent, or assent, if below the legal age of consent;
* 2) is younger than 18 months before the transition boundary of their CAMHS;
* 3) has intellectual impairment (IQ \< 70) as ascertained by standardized assessment or diagnosed by clinician;
* 4) if not able to (or expected not to be able to) complete the questionnaires due to severe physical disabilities or language problems, even with assistance from family members or research assistant.

Primary outcomes:
measure: Patient's health status (need for care)
timeFrame: Before transition compared to after transition (18 months)
Secondary outcomes:
measure: Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) self report
timeFrame: Baseline, 6, 12 and 18 months
measure: Transition Related Outcome Measure (TROM)
timeFrame: 6, 12 or 18 months
measure: Child Behavior Checklist (CBCL) or Adult Behavior Checklist (ABCL)
timeFrame: Baseline and 18 months
measure: Clinical Global Impression Scale (CGIS)
timeFrame: Baseline, 6, 12 and 18 months
measure: World Health Organisation's quality of life (WHOQOL-BREF)
timeFrame: Baseline and 18 months
measure: EuroQol generic quality of life questionnaire (5Q-5D-5L)
timeFrame: Baseline, 6, 12 and 18 months
measure: On Your Own Feet - Transition Experience Scale (OYOF-TES)
timeFrame: 6, 12 or 18 months
measure: Barriers to Care (BtC)
timeFrame: 6, 12 and 18 months
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Baseline, 6, 12 and 18 months
measure: Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) clinician version
timeFrame: Baseline, 6, 12, and 18 months
measure: Kiddie Schedule for Affective Disorders and Schizophrenia-Present State and Lifetime (K-SADS-PL)
timeFrame: Baseline and 18 months
measure: Prodromal questionnaire (PQ-16)
timeFrame: Baseline and 18 months
measure: General Assessment Scale for Social Functioning (GASC)
timeFrame: Baseline and 18 months
measure: Reflective Functioning Questionnaire (RFQ and PRFQ) self-report and parent version
timeFrame: Baseline
measure: Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
timeFrame: Baseline
measure: Multidimensional Peer Victimization Scale-Revised (MPVS-R)
timeFrame: Baseline and 18 months
measure: Coddington Life Event Scale (CLES)
timeFrame: Baseline, 6, 12 and 18 months
measure: Perceived Stress Reactivity Scale (PSRS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University of Geneva
Study officials:
References:
citation: Waylen A, Wolke D. Sex 'n' drugs 'n' rock 'n' roll: the meaning and social consequences of pubertal timing. Eur J Endocrinol. 2004 Nov;151 Suppl 3:U151-9. doi: 10.1530/eje.0.151u151.
citation: Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):617-27. doi: 10.1001/archpsyc.62.6.617.
citation: McGorry PD. The specialist youth mental health model: strengthening the weakest link in the public mental health system. Med J Aust. 2007 Oct 1;187(S7):S53-6. doi: 10.5694/j.1326-5377.2007.tb01338.x.
citation: McGorry P. Transition to adulthood: the critical period for pre-emptive, disease-modifying care for schizophrenia and related disorders. Schizophr Bull. 2011 May;37(3):524-30. doi: 10.1093/schbul/sbr027.
citation: Pottick KJ, Bilder S, Vander Stoep A, Warner LA, Alvarez MF. US patterns of mental health service utilization for transition-age youth and young adults. J Behav Health Serv Res. 2008 Oct;35(4):373-89. doi: 10.1007/s11414-007-9080-4. Epub 2007 Nov 17.
citation: Kataoka SH, Zhang L, Wells KB. Unmet need for mental health care among U.S. children: variation by ethnicity and insurance status. Am J Psychiatry. 2002 Sep;159(9):1548-55. doi: 10.1176/appi.ajp.159.9.1548.
citation: Forbes A, While A, Ullman R, et al. A multi-method review to identify components of practice which may promote continuity in the transition from child to adult care for young people with chronic illness or disability. Report for the National Coordinating Centre for NHS Service Delivery and Organisation R & D (NCCSDO). London, UK: The Florence Nightingale School of Nursing and Midwifery, King's College, 2002.
citation: Kennedy A, Sloman F, Douglass JA, Sawyer SM. Young people with chronic illness: the approach to transition. Intern Med J. 2007 Aug;37(8):555-60. doi: 10.1111/j.1445-5994.2007.01440.x.
citation: Kennedy P, Pugh R, Millar E. Towards managing the whole system of care and improving continuity of care. Psychiatric Bulletin, 29(7): 252-254, 2005
citation: Davis M. Addressing the needs of youth in transition to adulthood. Adm Policy Ment Health. 2003 Jul;30(6):495-509. doi: 10.1023/a:1025027117827.
citation: Singh S P, Paul M, Islam Z, et al. Transition from CAMHS to adult mental health services (TRACK): a study of service organisation, policies, process and user and carer perspectives. 2010. Report for the national institute for health research service delivery and organisation programme (SDO Project 08/1613/117).
citation: Wilson A, Tuffrey A, McKenzie C, Street C. After the flood: young people's perspectives on transition. Lancet Psychiatry. 2015 May;2(5):376-378. doi: 10.1016/S2215-0366(15)00126-1. Epub 2015 Apr 28. No abstract available.
citation: Paul M, Street C, Wheeler N, Singh SP. Transition to adult services for young people with mental health needs: A systematic review. Clin Child Psychol Psychiatry. 2015 Jul;20(3):436-57. doi: 10.1177/1359104514526603. Epub 2014 Apr 7.
citation: Hovish K, Weaver T, Islam Z, Paul M, Singh SP. Transition experiences of mental health service users, parents, and professionals in the United Kingdom: a qualitative study. Psychiatr Rehabil J. 2012 Winter;35(3):251-7. doi: 10.2975/35.3.2012.251.257.
citation: McDonagh JE, Viner RM. Lost in transition? Between paediatric and adult services. BMJ. 2006 Feb 25;332(7539):435-6. doi: 10.1136/bmj.332.7539.435. No abstract available.
citation: Colver AF, Merrick H, Deverill M, Le Couteur A, Parr J, Pearce MS, Rapley T, Vale L, Watson R, McConachie H; Transition Collaborative Group. Study protocol: longitudinal study of the transition of young people with complex health needs from child to adult health services. BMC Public Health. 2013 Jul 23;13:675. doi: 10.1186/1471-2458-13-675.
citation: Aebi M, Kuhn C, Metzke CW, Stringaris A, Goodman R, Steinhausen HC. The use of the development and well-being assessment (DAWBA) in clinical practice: a randomized trial. Eur Child Adolesc Psychiatry. 2012 Oct;21(10):559-67. doi: 10.1007/s00787-012-0293-6. Epub 2012 Jun 22.
citation: Singh SP. Transition of care from child to adult mental health services: the great divide. Curr Opin Psychiatry. 2009 Jul;22(4):386-90. doi: 10.1097/YCO.0b013e32832c9221.
citation: Suhrcke M, Pillas D, Selai C. Economic aspects of mental health in children and adolescents. Social Cohesion for Mental Wellbeing among adolescents: WHO, 43-64, 2008.
citation: Petrou S, Johnson S, Wolke D, Hollis C, Kochhar P, Marlow N. Economic costs and preference-based health-related quality of life outcomes associated with childhood psychiatric disorders. Br J Psychiatry. 2010 Nov;197(5):395-404. doi: 10.1192/bjp.bp.110.081307.
citation: Copeland WE, Wolke D, Shanahan L, Costello EJ. Adult Functional Outcomes of Common Childhood Psychiatric Problems: A Prospective, Longitudinal Study. JAMA Psychiatry. 2015 Sep;72(9):892-9. doi: 10.1001/jamapsychiatry.2015.0730.
citation: Relton C, Torgerson D, O'Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design. BMJ. 2010 Mar 19;340:c1066. doi: 10.1136/bmj.c1066. No abstract available.
citation: Hayes RJ, Moulton LH. Cluster randomised trials: Chapman & Hall/CRC; 2009.
citation: Gowers SG, Harrington RC, Whitton A, Lelliott P, Beevor A, Wing J, Jezzard R. Brief scale for measuring the outcomes of emotional and behavioural disorders in children. Health of the Nation Outcome Scales for children and Adolescents (HoNOSCA). Br J Psychiatry. 1999 May;174:413-6. doi: 10.1192/bjp.174.5.413.
citation: Achenbach, T.M. and L.A. Rescorla, Manual for the ASEBA school-age forms and profiles. 2001, Burlington, VT: University of Vermont, Research Center for Children, Youth and Families.
citation: Achenbach, T.M. and L.A. Rescorla, Manual for the ASEBA adult forms and profiles. 2003, Burlington, VT: University of Vermont, Research Center for Children, Youth and Families.
citation: Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997 Jul;36(7):980-8. doi: 10.1097/00004583-199707000-00021.
citation: Loewy RL, Pearson R, Vinogradov S, Bearden CE, Cannon TD. Psychosis risk screening with the Prodromal Questionnaire--brief version (PQ-B). Schizophr Res. 2011 Jun;129(1):42-6. doi: 10.1016/j.schres.2011.03.029. Epub 2011 Apr 20.
citation: Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: U.S. Department of Health, Education, and Welfare; 1976.
citation: Cornblatt BA, Auther AM, Niendam T, Smith CW, Zinberg J, Bearden CE, Cannon TD. Preliminary findings for two new measures of social and role functioning in the prodromal phase of schizophrenia. Schizophr Bull. 2007 May;33(3):688-702. doi: 10.1093/schbul/sbm029. Epub 2007 Apr 17.
citation: Skevington SM, Sartorius N, Amir M. Developing methods for assessing quality of life in different cultural settings. The history of the WHOQOL instruments. Soc Psychiatry Psychiatr Epidemiol. 2004 Jan;39(1):1-8. doi: 10.1007/s00127-004-0700-5.
citation: Coddington RD. The significance of life events as etiologic factors in the diseases of children. II. A study of a normal population. J Psychosom Res. 1972 Jun;16(3):205-13. doi: 10.1016/0022-3999(72)90045-1. No abstract available.
citation: Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.
citation: Luyten P, Mayes LC, Nijssens L, Fonagy P. The parental reflective functioning questionnaire: Development and preliminary validation. PLoS One. 2017 May 4;12(5):e0176218. doi: 10.1371/journal.pone.0176218. eCollection 2017.
citation: Gooding DC, Pflum MJ. The assessment of interpersonal pleasure: introduction of the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) and preliminary findings. Psychiatry Res. 2014 Jan 30;215(1):237-43. doi: 10.1016/j.psychres.2013.10.012. Epub 2013 Oct 22.
citation: Betts LR, Houston JE, Steer OL. Development of the Multidimensional Peer Victimization Scale-Revised (MPVS-R) and the Multidimensional Peer Bullying Scale (MPVS-RB). J Genet Psychol. 2015 Jan-Apr;176(1-2):93-109. doi: 10.1080/00221325.2015.1007915. Epub 2015 Mar 16.
citation: Schlotz W, Yim IS, Zoccola PM, Jansen L, Schulz P. The Perceived Stress Reactivity Scale: measurement invariance, stability, and validity in three countries. Psychol Assess. 2011 Mar;23(1):80-94. doi: 10.1037/a0021148.
citation: Nelson EC, Eftimovska E, Lind C, Hager A, Wasson JH, Lindblad S. Patient reported outcome measures in practice. BMJ. 2015 Feb 10;350:g7818. doi: 10.1136/bmj.g7818. No abstract available.
citation: Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B. Client Socio-Demographic and Service Receipt Inventory--European Version: development of an instrument for international research. EPSILON Study 5. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs. Br J Psychiatry Suppl. 2000;(39):s28-33. doi: 10.1192/bjp.177.39.s28.
citation: Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
citation: Vanheusden K, Mulder CL, van der Ende J, van Lenthe FJ, Mackenbach JP, Verhulst FC. Young adults face major barriers to seeking help from mental health services. Patient Educ Couns. 2008 Oct;73(1):97-104. doi: 10.1016/j.pec.2008.05.006. Epub 2008 Jun 27.
citation: van Staa A, Sattoe JN. Young adults' experiences and satisfaction with the transfer of care. J Adolesc Health. 2014 Dec;55(6):796-803. doi: 10.1016/j.jadohealth.2014.06.008. Epub 2014 Aug 19.
citation: Preti A, Pisano A, Cascio MT, Galvan F, Monzani E, Meneghelli A, Cocchi A. Validation of the Health of the Nation Outcome Scales as a routine measure of outcome in early intervention programmes. Early Interv Psychiatry. 2012 Nov;6(4):423-31. doi: 10.1111/j.1751-7893.2011.00329.x. Epub 2012 Jan 8.
citation: Tuomainen H, Schulze U, Warwick J, Paul M, Dieleman GC, Franic T, Madan J, Maras A, McNicholas F, Purper-Ouakil D, Santosh P, Signorini G, Street C, Tremmery S, Verhulst FC, Wolke D, Singh SP; MILESTONE consortium. Managing the link and strengthening transition from child to adult mental health Care in Europe (MILESTONE): background, rationale and methodology. BMC Psychiatry. 2018 Jun 4;18(1):167. doi: 10.1186/s12888-018-1758-z.