Clinical trial NCT03013595: The MILESTONE Study: Improving Transition From Child to Adult Mental Health Care
Official title: The Effectiveness of Managed Transition in Improving the Health and Social Outcomes for Young People Transitioning From Child to Adult Mental Health Care: the MILESTONE Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Impairment
Mental Health Disorder
Keywords: Mental health
Youth mental health
Adolescent
Health services
Transition
Longitudinal cohort study
Cluster randomised controlled trial
Young adult
Lead sponsor: University of Warwick
Sponsor class: OTHER
Collaborators: name: European Union
name: IRCCS Centro San Giovanni di Dio Fatebenefratelli
name: King's College London
name: University Hospital, Montpellier
name: Yulius
name: University of Ulm
name: KU Leuven
name: University College Dublin
name: Clinical Hospital Center, Split
name: HealthTracker Ltd, UK
name: Erasmus Medical Center
name: Concentris research management gmbh
First posted: 2017-01-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates the longitudinal health and social outcomes of adolescent mental health service users who are at the transition boundary of their child and adolescent mental health service, and whether the implementation of a model of managed transition at the service boundary benefits them, as compared to usual care.

Detailed description: The MILESTONE study focuses on the period when young people attending a children and adolescents mental health service (CAMHS) need to move on, or "transition", to an adult mental health service (AMHS), if they still require care or treatment. We know from other research that this transition is not always properly managed and that improving the transition process can have a positive impact on the health and well-being of young people in this position. We want to evaluate what impact the different transition experiences have on young people's health and well-being, and whether the process of Managed Transition has any benefits as compared to usual care.

The MILESTONE study is run in eight European countries (UK, Ireland, Belgium, Holland, France, Germany, Italy and Croatia). CAMHS in the study regions are selected to provide the young people in their care that are reaching transition age either usual care or a novel service called "Managed Transition", which includes the use of a new decision support tool, the Transition Readiness and Appropriateness Measure (TRAM). This should help with decision making and enable better transitions by identifying cases for whom transition from CAMHS to AMHS is advisable and appropriate, or who can be safely discharged or referred to a community based service. CAMHS are randomly assigned to provide the intervention of Managed Transition or usual care. The health and well-being of the young people attending these services is assessed at the start of the study and then followed-up for 24 months to see whether they transition to AMHS or are discharged or referred to some other service.

Eligibility criteria: Inclusion Criteria:

* Young person inclusion:

  1. Provides valid written informed consent, or assent, if below the legal age of consent
  2. If age is within one year of reaching the transition boundary of their CAMHS during the trial recruitment period, and, in exceptional cases, not more than 3 months older than the transition boundary, if a decision about transition has not yet been made
  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 standardised 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 a year before the transition boundary of their CAMHS 3. Has intellectual impairment (IQ \<70) as ascertained by previous standardised assessment or diagnosed by clinician (if no data on intellectual functioning are available \[because it has never been assessed\] then care coordinators will be asked to make a clinical judgement on intellectual impairment before baseline assessment takes place) 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 5. Service user in a secure forensic institution

Primary outcomes:
measure: Mental health status (need for care) as measured by Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA - clinician version) at 15 months
timeFrame: 15 months
Secondary outcomes:
measure: Self-rated (i.e. completed by young person) mental health status (need for care) on Health of the Nation Outcome Scale for Children and Adolescents (HONOSCA)
timeFrame: Baseline, 9, 15, and 24 months
measure: Transition outcome assessed by the Transition Related Outcome Measure (TROM) questionnaire
timeFrame: Baseline, 9, 15, and 24 months
measure: Emotional and behavioural problems assessed by the Achenbach System of Empirically Based Assessment (ASEBA) Youth Self Report (YSR)/Adult Self Report (ASR) questionnaires (young person)
timeFrame: Baseline, 9, 15, and 24 months
measure: Emotional and behavioural problems assessed by the Achenbach System of Empirically Based Assessment (ASEBA) Child Behavior Checklist (CBCL) or Adult Behavior Checklist (ABCL) questionnaires (parent/carer)
timeFrame: Baseline, 9, 15, and 24 months
measure: Illness severity assessed by Clinical Global Impression Severity (CGIS) scale (CGIseverity)
timeFrame: Baseline, 9, 15, and 24 months
measure: Quality of life assessed by World Health Organisation Quality of Life Assessment (WHOQOLBREF)
timeFrame: Baseline, 15, and 24 months
measure: Independent behaviour assessed by Independent Behaviour During Consultation Scale (IBDCS)
timeFrame: Baseline, 9, 15, and 24 months, if young person is a current service user
measure: Illness perception assessed by the Brief Illness Perception Questionnaire (BIPQ)
timeFrame: Baseline and 24 months
measure: Barriers to care assessed by Barriers to Care (BtC) checklist
timeFrame: 9, 15, and 24 months, if young person is no longer a service user
measure: Transition experience and readiness assessed by On Your Own Feet - Transition Experience Scale (OYOF-TES)
timeFrame: at 9, 15 or 24 months, completed only once at the first assessment after transition
measure: Adult functioning assessed by Specific Levels of Functioning Scale (SLOF)
timeFrame: Baseline and 24 months
measure: Quality Adjusted Life Years (QALYs) assessed by EuroQol generic quality of life questionnaire (EQ-5D-5L)
timeFrame: Baseline, 9, 15, and 24 months
measure: Service use assessed by a MILESTONE specific Client Service Receipt Inventory (CSRI)
timeFrame: Baseline, 9, 15, and 24 months
measure: Mental health status as measured by Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA - clinician version)
timeFrame: Baseline, 9 months, 24 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
city: Split
country: Croatia
facility: University Hospital Split
city: Montpellier
country: France
facility: CHRU Montpellier-St Eloi hospital
city: Ulm
country: Germany
facility: University of Ulm
city: Dublin
country: Ireland
facility: University College Dublin
city: Brescia
country: Italy
facility: IRCCS Fatebenefratelli
city: Barendrecht
country: Netherlands
facility: Yulius Academy
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
city: Coventry
country: United Kingdom
facility: Warwick Medical School, University of Warwick
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: Warwick Medical School, University of Warwick, UK
name: Swaran P Singh, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerritsen SE, Maras A, van Bodegom LS, Overbeek MM, Verhulst FC, Wolke D, Appleton R, Bertani A, Cataldo MG, Conti P, Da Fonseca D, Davidovic N, Dodig-Curkovic K, Ferrari C, Fiori F, Franic T, Gatherer C, De Girolamo G, Heaney N, Hendrickx G, Kolozsvari A, Levi FM, Lievesley K, Madan J, Martinelli O, Mastroianni M, Maurice V, McNicholas F, O'Hara L, Paul M, Purper-Ouakil D, de Roeck V, Russet F, Saam MC, Sagar-Ouriaghli I, Santosh PJ, Sartor A, Schandrin A, Schulze UME, Signorini G, Singh SP, Singh J, Street C, Tah P, Tanase E, Tremmery S, Tuffrey A, Tuomainen H, van Amelsvoort TAMJ, Wilson A, Walker L, Dieleman GC; Milestone consortium. Cohort profile: demographic and clinical characteristics of the MILESTONE longitudinal cohort of young people approaching the upper age limit of their child mental health care service in Europe. BMJ Open. 2021 Dec 16;11(12):e053373. doi: 10.1136/bmjopen-2021-053373.
citation: Santosh P, Singh J, Adams L, Mastroianni M, Heaney N, Lievesley K, Sagar-Ouriaghli I, Allibrio G, Appleton R, Davidovic N, de Girolamo G, Dieleman G, Dodig-Curkovic K, Franic T, Gatherer C, Gerritsen S, Gheza E, Madan J, Manenti L, Maras A, Margari F, McNicholas F, Pastore A, Paul M, Purper-Ouakil D, Rinaldi F, Sakar V, Schulze U, Signorini G, Street C, Tah P, Tremmery S, Tuffrey A, Tuomainen H, Verhulst F, Warwick J, Wilson A, Wolke D, Fiori F, Singh S; MILESTONE Consortium. Validation of the Transition Readiness and Appropriateness Measure (TRAM) for the Managing the Link and Strengthening Transition from Child to Adult Mental Healthcare in Europe (MILESTONE) study. BMJ Open. 2020 Jun 23;10(6):e033324. doi: 10.1136/bmjopen-2019-033324.
citation: Santosh P, Adams L, Fiori F, Davidovic N, de Girolamo G, Dieleman GC, Franic T, Heaney N, Lievesley K, Madan J, Maras A, Mastroianni M, McNicholas F, Paul M, Purper-Ouakil D, Sagar-Ouriaghli I, Schulze U, Signorini G, Street C, Tah P, Tremmery S, Tuomainen H, Verhulst FC, Warwick J, Wolke D, Singh J, Singh SP; MILESTONE Consortium. Protocol for the development and validation procedure of the managing the link and strengthening transition from child to adult mental health care (MILESTONE) suite of measures. BMC Pediatr. 2020 Apr 16;20(1):167. doi: 10.1186/s12887-020-02079-9.
citation: 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.
citation: Singh SP, Tuomainen H, Girolamo G, Maras A, Santosh P, McNicholas F, Schulze U, Purper-Ouakil D, Tremmery S, Franic T, Madan J, Paul M, Verhulst FC, Dieleman GC, Warwick J, Wolke D, Street C, Daffern C, Tah P, Griffin J, Canaway A, Signorini G, Gerritsen S, Adams L, O'Hara L, Aslan S, Russet F, Davidovic N, Tuffrey A, Wilson A, Gatherer C, Walker L; MILESTONE Consortium. Protocol for a cohort study of adolescent mental health service users with a nested cluster randomised controlled trial to assess the clinical and cost-effectiveness of managed transition in improving transitions from child to adult mental health services (the MILESTONE study). BMJ Open. 2017 Oct 16;7(10):e016055. doi: 10.1136/bmjopen-2017-016055.