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Psychiatric DisorderSORTNCT04249960

Sustain and Reinforce the Transition From Child to Adult Mental Health Care in Switzerland : A Monocentric Nested Cohort Randomized Controlled Trial: The SORT Study.

A study testing Managed transition in people with Psychiatric Disorder and Transition, run by University of Geneva, Switzerland at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 18 years
Conditions the study is for
Psychiatric Disorder, Transition
What is being tested?
Managed transition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSwitzerland
Study dates
9 Oct 2019to 28 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Marco Armando, MD, PhD contact

+41 22 388 67 56

Marco.Armando@unige.ch

Switzerland1 site, 1 recruiting
  • University of Geneva

    Geneva, 1211

    Marco Armando, MD, PhD, 0041223886756, Marco.Armando@unige.ch

    Recruiting

Other trials in Switzerland

About this study

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.

Being tested
Managed transition
Keywords
adolescents, psychiatric disorders, CAMHS, AMHS, transition
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Managed transitionBehavioural

    Young people, their family and clinicians will receive transition guidelines and will be asked to follow them as much as possible.

Study groups in NCT04249960
Study groupRoleWhat they receive
Transition as usualNo interventionYoung people in this group will receive usual care and transition as usual, they will be our control group.
Managed transitionExperimentalYoung people in this group will do the managed transition, they will be our experimental group.
Receives: Behavioral: Managed transition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient's health status (need for care)

    Measured at each time point using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) completed by a trained research assistant. Scores will be compared between first and last time point. HoNOSCA is 5 point scale going from 0 = not a problem, 1 = minor issue not requiring intervention, 2 = slightly problematic, 3 = moderately serious problem, 4 = serious to very serious problem, 9= unknown/not applicable. Scores are calculated by adding up all the subscales (9s are not counted) and a higher score means a worse outcome.

    Measured: Before transition compared to after transition (18 months)

Secondary outcomes (18)
  1. Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) self report

    Self-report "need for care" status measured by the Health of the Nation Outcome Scale for Children and Adolescents

    Measured: Baseline, 6, 12 and 18 months

  2. Transition Related Outcome Measure (TROM)

    Transition Related Outcome Measure to assess outcomes post-transition completed by the young person, parent/carer and clinician

    Measured: 6, 12 or 18 months

  3. Child Behavior Checklist (CBCL) or Adult Behavior Checklist (ABCL)

    Emotional and behavioral disturbances measured by the Achenbach System of Empirically Based Assessment (ASEBA) Child Behavior Checklist (CBCL) or Adult Behavior Checklist (ABCL) questionnaires (parent/carer version). CBCL targets young people until 17 and ABCL after 17.

    Measured: Baseline and 18 months

  4. Clinical Global Impression Scale (CGIS)

    The Clinical Global Impression Scale completed by the clinician assesses patient's ilness severity

    Measured: Baseline, 6, 12 and 18 months

  5. World Health Organisation's quality of life (WHOQOL-BREF)

    Young person's quality of life is measured by World Health Organisation's quality of life questionnaire. It is completed by the young person.

    Measured: Baseline and 18 months

  6. EuroQol generic quality of life questionnaire (5Q-5D-5L)

    Quality Adjusted Life Years (QALYs) and cost effectiveness are assessed by EuroQol generic quality of life questionnaire completed by the young person.

    Measured: Baseline, 6, 12 and 18 months

  7. On Your Own Feet - Transition Experience Scale (OYOF-TES)

    Transition experience and readiness assessed by On Your Own Feet - Transition Experience Scale completed by the young person and parent/carer only once at the time point right after transition

    Measured: 6, 12 or 18 months

  8. Barriers to Care (BtC)

    Barriers to care assessed by Barriers to Care checklist completed by the young person if he/she is not using the available services any more

    Measured: 6, 12 and 18 months

  9. Client Service Receipt Inventory (CSRI)

    Service use assessed by a Client Service Receipt Inventory adapted from the Milestone study; completed by the young person

    Measured: Baseline, 6, 12 and 18 months

  10. Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) clinician version

    Need for care and mental health status measured by Health of the Nation Outcome Scale for Children and Adolescents completed by a trained research assistant with information from the young person, parent/carer and clinician to ensure accuracy

    Measured: Baseline, 6, 12, and 18 months

  11. Kiddie Schedule for Affective Disorders and Schizophrenia-Present State and Lifetime (K-SADS-PL)

    Kiddie Schedule for Affective Disorders and Schizophrenia-Present State and Lifetime Version for DSM-IV performed by a trained research assistant

    Measured: Baseline and 18 months

  12. Prodromal questionnaire (PQ-16)

    Prodromal questionnaire to assess prodromal symptoms filled by the young person as a self report

    Measured: Baseline and 18 months

  13. General Assessment Scale for Social Functioning (GASC)

    General Assessment Scale for Social Functioning assesses patients general functioning filled by the clinician

    Measured: Baseline and 18 months

  14. Reflective Functioning Questionnaire (RFQ and PRFQ) self-report and parent version

    Reflective Functioning Questionnaire assesses mentalisation abilities filled by the young person and parent/carer (two versions)

    Measured: Baseline

  15. Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)

    Social abilities are measured by the Anticipatory and Consummatory Interpersonal Pleasure Scale self report and parent/carer version

    Measured: Baseline

  16. Multidimensional Peer Victimization Scale-Revised (MPVS-R)

    Multidimensional Peer Victimization Scale-Revised assesses bullying as a self report

    Measured: Baseline and 18 months

  17. Coddington Life Event Scale (CLES)

    Important life events is assessed by the Coddington Life Event Scale self-report

    Measured: Baseline, 6, 12 and 18 months

  18. Perceived Stress Reactivity Scale (PSRS)

    Young person's stress status is measured by the Perceived Stress Reactivity Scale self report

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2020
  2. Study start9 Oct 2019
  3. Primary completion1 Sep 2021 (estimated)
  4. Study completion28 Feb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04249960
Sponsor's protocol ID
2019-0853
Acronym
SORT
Status last verified
Jan 2020
First submitted
14 Nov 2019
Last updated
31 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 15554900
  • 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.

    PubMed 15939839
  • 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.

    PubMed 17908028
  • 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.

    PubMed 21505119
  • 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.

    PubMed 18026842
  • 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.

    PubMed 12202276
  • 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.

  • 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.

    PubMed 17640188
  • 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

  • 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.

    PubMed 13677456
  • 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).

  • 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.

    PubMed 26360268
  • 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.

    PubMed 24711585
  • 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.

    PubMed 22246124
  • 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.

    PubMed 16497736

Questions about this trial

What is this clinical trial studying?

A study testing Managed transition in people with Psychiatric Disorder and Transition, run by University of Geneva, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marco Armando, MD, PhD (+41 22 388 67 56, Marco.Armando@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient's health status (need for care) (time frame: Before transition compared to after transition (18 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04249960, which also lists 44 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.

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