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

NCT04249960 | Unknown

• 1 other identifier: 2019-0853
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychiatric Disorder; Transition

Keywords

adolescents; psychiatric disorders; CAMHS; AMHS; transition

Outcome Measures

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.

  Before transition compared to after transition (18 months)

Secondary Outcomes (18)

• Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) self report

  Baseline, 6, 12 and 18 months

• Transition Related Outcome Measure (TROM)

  6, 12 or 18 months

• Child Behavior Checklist (CBCL) or Adult Behavior Checklist (ABCL)

  Baseline and 18 months

• Clinical Global Impression Scale (CGIS)

  Baseline, 6, 12 and 18 months

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

  Baseline and 18 months

Study Arms (2)

Transition as usual

NO INTERVENTION

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

Managed transition

EXPERIMENTAL

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

Behavioral: Managed transition

Interventions

Managed transition BEHAVIORAL

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

Managed transition

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

Study Sites (1)

University of Geneva

Geneva, 1211, Switzerland

RECRUITING

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Related Links

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

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Marco Armando, MD, PhD

CONTACT

+41 22 388 67 56; Marco.Armando@unige.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: January 31, 2020
• Study Start: October 9, 2019
• Primary Completion: September 1, 2021
• Study Completion: February 28, 2022
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

CH (1)