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

Psychiatric Disorder Clinical Trial

— SORT  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04249960
• Other study ID #: 2019-0853
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: January 2020
• Source: University of Geneva, Switzerland
• Contact: Marco Armando, MD, PhD
• Phone: +41 22 388 67 56
• Email: Marco.Armando[@]unige.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Psychiatric Disorder
• Transition

Intervention

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

Locations

Country	Name	City	State
Switzerland	University of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before transition compared to after transition (18 months)
Secondary	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	Baseline, 6, 12 and 18 months
Secondary	Transition Related Outcome Measure (TROM)	Transition Related Outcome Measure to assess outcomes post-transition completed by the young person, parent/carer and clinician	6, 12 or 18 months
Secondary	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.	Baseline and 18 months
Secondary	Clinical Global Impression Scale (CGIS)	The Clinical Global Impression Scale completed by the clinician assesses patient's ilness severity	Baseline, 6, 12 and 18 months
Secondary	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.	Baseline and 18 months
Secondary	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.	Baseline, 6, 12 and 18 months
Secondary	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	6, 12 or 18 months
Secondary	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	6, 12 and 18 months
Secondary	Client Service Receipt Inventory (CSRI)	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
Secondary	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	Baseline, 6, 12, and 18 months
Secondary	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	Baseline and 18 months
Secondary	Prodromal questionnaire (PQ-16)	Prodromal questionnaire to assess prodromal symptoms filled by the young person as a self report	Baseline and 18 months
Secondary	General Assessment Scale for Social Functioning (GASC)	General Assessment Scale for Social Functioning assesses patients general functioning filled by the clinician	Baseline and 18 months
Secondary	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)	Baseline
Secondary	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	Baseline
Secondary	Multidimensional Peer Victimization Scale-Revised (MPVS-R)	Multidimensional Peer Victimization Scale-Revised assesses bullying as a self report	Baseline and 18 months
Secondary	Coddington Life Event Scale (CLES)	Important life events is assessed by the Coddington Life Event Scale self-report	Baseline, 6, 12 and 18 months
Secondary	Perceived Stress Reactivity Scale (PSRS)	Young person's stress status is measured by the Perceived Stress Reactivity Scale self report	Baseline

External Links

•   NICE Guidelines on transition in mental health
•   UK Guidelines on transition in mental health