The MILESTONE Study: Improving Transition From Child to Adult Mental Health Care
NCT ID: NCT03013595
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2015-10-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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TRAM feedback
1. The completion of the "Transition Readiness and Appropriateness Measure" (TRAM, a standardized structured assessment ) prior to the transition boundary by the child and adolescent mental health service (CAMHS) clinician, young person and parent/carer.
2. Feedback of TRAM findings to the CAMHS clinician to support decisions made regarding transition, communication with stakeholders and the transition process. Clinicians will be expected to communicate the findings to the young person and parent/carer, and, if a referral is made, to send the TRAM feedback to the adult clinician along with the referral letter.
3. The clinicians will also receive information prior to recruitment begin on the use of TRAM and the way in which it fits in with optimal transition.
TRAM feedback
Usual care
Patients, parent/carers and clinicians in the control arm will complete the TRAM prior to the transition boundary, but the clinicians won't receive any feedback from it nor any information on the benefits of using the decision support tool.
No interventions assigned to this group
Interventions
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TRAM feedback
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
15 Years
18 Years
ALL
No
Sponsors
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European Union
OTHER
IRCCS Centro San Giovanni di Dio Fatebenefratelli
OTHER
King's College London
OTHER
University Hospital, Montpellier
OTHER
Yulius
UNKNOWN
University of Ulm
OTHER
KU Leuven
OTHER
University College Dublin
OTHER
Clinical Hospital Center, Split
OTHER
HealthTracker Ltd, UK
UNKNOWN
Erasmus Medical Center
OTHER
Concentris research management gmbh
UNKNOWN
University of Warwick
OTHER
Responsible Party
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Swaran Singh
Professor
Principal Investigators
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Swaran P Singh, MD, DM
Role: PRINCIPAL_INVESTIGATOR
Warwick Medical School, University of Warwick, UK
Locations
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Katholieke Universiteit Leuven
Leuven, , Belgium
University Hospital Split
Split, , Croatia
CHRU Montpellier-St Eloi hospital
Montpellier, , France
University of Ulm
Ulm, , Germany
University College Dublin
Dublin, , Ireland
IRCCS Fatebenefratelli
Brescia, , Italy
Yulius Academy
Barendrecht, , Netherlands
Erasmus Medical Centre
Rotterdam, , Netherlands
Warwick Medical School, University of Warwick
Coventry, , United Kingdom
King's College London
London, , United Kingdom
Countries
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References
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Magno M, Martella D, Leone S, Allibrio G, Bertani A, Caselani E, Conti P, Cortese S, Dieleman G, Franic T, Gerritsen S, Maffezzoni D, Margari F, Martinelli O, McNicholas F, Micciolo R, Nacinovich R, Purper Ouakil D, Pastore A, Rinaldi F, Santosh P, Scocco P, Schulze U, Singh S, Squarcia A, Stagi P, Street C, Toffol E, Tuomainen H, van Bodegom LS, Vicari S, de Girolamo G; on behalf the MILESTONE Consortium. Mental health trajectories of adolescents treated with psychotropic medications: insights from the european milestone study. Mol Psychiatry. 2025 Oct 17. doi: 10.1038/s41380-025-03307-3. Online ahead of print.
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.
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.
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.
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.
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.
Other Identifiers
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ISRCTN83240263
Identifier Type: REGISTRY
Identifier Source: secondary_id
REC15/WM/0052
Identifier Type: -
Identifier Source: org_study_id