CClinicalTrials.gg
Status unknownNCT04249960SORTUpdated Jan 31, 2020

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

An interventional study of Managed transition in Psychiatric Disorder and Transition, sponsored by University of Geneva, Switzerland. Status unknown at 1 site in Switzerland. Open to participants aged 16 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-01-31.

Sponsored by University of Geneva, Switzerland · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
16 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psychiatric Disorder
  • Transition

Keywords

  • adolescents
  • psychiatric disorders
  • CAMHS
  • AMHS
  • transition
03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's planned enrollment of 200 is above the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

University of Geneva, Switzerland is the lead sponsor of 43 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. provides valid written informed consent, or assent, if below the legal age of consent;
    1. age is within 18 months of reaching the transition boundary of their CAMHS - during the trial recruitment period;
    1. 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);
    1. Has an IQ ≥ 70 as ascertained by previous standardized assessment or diagnosed by clinician, or no indication of intellectual impairment.

Exclusion criteria

Exclusion Criteria:

    1. does not provide valid written informed consent, or assent, if below the legal age of consent;
    1. is younger than 18 months before the transition boundary of their CAMHS;
    1. has intellectual impairment (IQ \< 70) as ascertained by standardized assessment or diagnosed by clinician;
    1. 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
200 participants (estimated)

Study arms

  • No intervention
    Transition as usual

    Young people in this group will receive usual care and transition as usual, they will be our control group.

  • Experimental
    Managed transition

    Young people in this group will do the managed transition, they will be our experimental group.

    Behavioral: Managed transition

Interventions

  • BehavioralManaged transition

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: Before transition compared to after transition (18 months)

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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.

    Time frame: Baseline and 18 months

  4. Clinical Global Impression Scale (CGIS)

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline and 18 months

  12. Prodromal questionnaire (PQ-16)

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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: Baseline

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

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

    Time frame: Baseline and 18 months

  17. Coddington Life Event Scale (CLES)

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

    Time frame: 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

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • University of Geneva
    Geneva, 1211, Switzerland
    Recruiting
08

References and documents

Publications

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  • 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. PubMed 15022040 ↗
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  • 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. PubMed 22225572 ↗
  • 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. Erratum In: BMC Psychiatry. 2018 Sep 14;18(1):295. doi: 10.1186/s12888-018-1881-x. PubMed 29866202 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04249960
Lead sponsor
University of Geneva, Switzerland
Responsible party
Dr Marco Armando (Principal Investigator, University of Geneva, Switzerland) — Principal investigator
First posted
Jan 31, 2020
Start date
Oct 9, 2019
Primary completion
Sep 1, 2021 (estimated)
Completion
Feb 28, 2022 (estimated)
Last update
Jan 31, 2020

Study contacts

Marco Armando, MD, PhD
Contact
Marco.Armando@unige.ch
+41 22 388 67 56

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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