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

January 28, 2020 updated by: Dr Marco Armando, University of Geneva, Switzerland

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Young people, their family and clinicians will receive transition guidelines and will be asked to follow them as much as possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before transition compared to after transition (18 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 6, 12 and 18 months
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
6, 12 or 18 months
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.
Baseline and 18 months
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
Baseline, 6, 12 and 18 months
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.
Baseline and 18 months
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.
Baseline, 6, 12 and 18 months
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
6, 12 or 18 months
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
6, 12 and 18 months
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
Baseline, 6, 12 and 18 months
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
Baseline, 6, 12, and 18 months
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
Baseline and 18 months
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
Baseline and 18 months
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
Baseline and 18 months
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)
Baseline
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
Baseline
Multidimensional Peer Victimization Scale-Revised (MPVS-R)
Time Frame: Baseline and 18 months
Multidimensional Peer Victimization Scale-Revised assesses bullying as a self report
Baseline and 18 months
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
Baseline, 6, 12 and 18 months
Perceived Stress Reactivity Scale (PSRS)
Time Frame: Baseline
Young person's stress status is measured by the Perceived Stress Reactivity Scale self report
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Geneva, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2019

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 31, 2020

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0853

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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