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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: September 1, 2021

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Patient’s health status (need for care)
    • Time Frame: Before transition compared to after transition (18 months)
    • 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.

Secondary Measures

  • Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) self report
    • Time Frame: Baseline, 6, 12 and 18 months
    • Self-report “need for care” status measured by the Health of the Nation Outcome Scale for Children and Adolescents
  • Transition Related Outcome Measure (TROM)
    • Time Frame: 6, 12 or 18 months
    • Transition Related Outcome Measure to assess outcomes post-transition completed by the young person, parent/carer and clinician
  • Child Behavior Checklist (CBCL) or Adult Behavior Checklist (ABCL)
    • Time Frame: Baseline and 18 months
    • 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.
  • Clinical Global Impression Scale (CGIS)
    • Time Frame: Baseline, 6, 12 and 18 months
    • The Clinical Global Impression Scale completed by the clinician assesses patient’s ilness severity
  • World Health Organisation’s quality of life (WHOQOL-BREF)
    • Time Frame: Baseline and 18 months
    • Young person’s quality of life is measured by World Health Organisation’s quality of life questionnaire. It is completed by the young person.
  • EuroQol generic quality of life questionnaire (5Q-5D-5L)
    • Time Frame: Baseline, 6, 12 and 18 months
    • Quality Adjusted Life Years (QALYs) and cost effectiveness are assessed by EuroQol generic quality of life questionnaire completed by the young person.
  • On Your Own Feet – Transition Experience Scale (OYOF-TES)
    • Time Frame: 6, 12 or 18 months
    • 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
  • Barriers to Care (BtC)
    • Time Frame: 6, 12 and 18 months
    • 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
  • Client Service Receipt Inventory (CSRI)
    • Time Frame: Baseline, 6, 12 and 18 months
    • Service use assessed by a Client Service Receipt Inventory adapted from the Milestone study; completed by the young person
  • Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) clinician version
    • Time Frame: Baseline, 6, 12, and 18 months
    • 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
  • Kiddie Schedule for Affective Disorders and Schizophrenia-Present State and Lifetime (K-SADS-PL)
    • Time Frame: Baseline and 18 months
    • Kiddie Schedule for Affective Disorders and Schizophrenia-Present State and Lifetime Version for DSM-IV performed by a trained research assistant
  • Prodromal questionnaire (PQ-16)
    • Time Frame: Baseline and 18 months
    • Prodromal questionnaire to assess prodromal symptoms filled by the young person as a self report
  • General Assessment Scale for Social Functioning (GASC)
    • Time Frame: Baseline and 18 months
    • General Assessment Scale for Social Functioning assesses patients general functioning filled by the clinician
  • Reflective Functioning Questionnaire (RFQ and PRFQ) self-report and parent version
    • Time Frame: Baseline
    • Reflective Functioning Questionnaire assesses mentalisation abilities filled by the young person and parent/carer (two versions)
  • Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
    • Time Frame: Baseline
    • Social abilities are measured by the Anticipatory and Consummatory Interpersonal Pleasure Scale self report and parent/carer version
  • Multidimensional Peer Victimization Scale-Revised (MPVS-R)
    • Time Frame: Baseline and 18 months
    • Multidimensional Peer Victimization Scale-Revised assesses bullying as a self report
  • Coddington Life Event Scale (CLES)
    • Time Frame: Baseline, 6, 12 and 18 months
    • Important life events is assessed by the Coddington Life Event Scale self-report
  • Perceived Stress Reactivity Scale (PSRS)
    • Time Frame: Baseline
    • Young person’s stress status is measured by the Perceived Stress Reactivity Scale self report

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Geneva, Switzerland
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Marco Armando, Principal Investigator – University of Geneva, Switzerland
  • Overall Contact(s)
    • Marco Armando, MD, PhD, +41 22 388 67 56, Marco.Armando@unige.ch

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