NCT03013595

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
8 countries

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2016

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

December 28, 2016

Last Update Submit

November 15, 2017

Conditions

Mental Health ImpairmentMental Health Disorder

Keywords

Mental healthYouth mental healthAdolescentHealth servicesTransitionLongitudinal cohort studyCluster randomised controlled trialYoung adult

Outcome Measures

Primary Outcomes (1)

  • 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

    The measure will be completed by a trained MILESTONE research assistant taking into account all available sources of information (including the young person, parent/carer, relevant clinician and the medical records) to ensure accuracy of data.

    15 months

Secondary Outcomes (14)

  • 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)

    Baseline, 9, 15, and 24 months

  • Transition outcome assessed by the Transition Related Outcome Measure (TROM) questionnaire

    Baseline, 9, 15, and 24 months

  • 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)

    Baseline, 9, 15, and 24 months

  • 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)

    Baseline, 9, 15, and 24 months

  • Illness severity assessed by Clinical Global Impression Severity (CGIS) scale (CGIseverity)

    Baseline, 9, 15, and 24 months

  • +9 more secondary outcomes

Study Arms (2)

TRAM feedback

EXPERIMENTAL

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.

Behavioral: TRAM feedback

Usual care

NO INTERVENTION

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.

Interventions

TRAM feedbackBEHAVIORAL
Also known as: Managed transition
TRAM feedback

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Provides valid written informed consent, or assent, if below the legal age of consent
  • 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
  • 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 standardised 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Katholieke Universiteit Leuven

Leuven, Belgium

Location

University Hospital Split

Split, Croatia

Location

CHRU Montpellier-St Eloi hospital

Montpellier, France

Location

University of Ulm

Ulm, Germany

Location

University College Dublin

Dublin, Ireland

Location

IRCCS Fatebenefratelli

Brescia, Italy

Location

Yulius Academy

Barendrecht, Netherlands

Location

Erasmus Medical Centre

Rotterdam, Netherlands

Location

Warwick Medical School, University of Warwick

Coventry, CV4 7AL, United Kingdom

Location

King's College London

London, SE5 8AF, United Kingdom

Location

Related Publications (7)

  • Marcolini F, Magno M, Leone S, Martella D, Leucci AC, Atti AR, Cortese S, De Ronchi D, Dieleman G, Franic T, Gerritsen S, Maras A, McNicholas F, Purper-Ouakil D, Santosh P, Schulze UME, Street C, Singh S, Tremmery S, Tuomainen H, van Bodegom LS, Wolke D, de Girolamo G; MILESTONE Consortium. Bridging Perspectives: Clinician-Adolescent Agreement on Psychopathological Severity in the European MILESTONE Cohort. J Clin Psychol. 2025 Nov 30. doi: 10.1002/jclp.70073. Online ahead of print.

    PMID: 41319312DERIVED

  • 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. 2026 Jan;31(1):94-103. doi: 10.1038/s41380-025-03307-3. Epub 2025 Oct 17.

    PMID: 41107439DERIVED

  • 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.

    PMID: 34916319DERIVED

  • 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.

    PMID: 32580979DERIVED

  • 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.

    PMID: 32299401DERIVED

  • 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.

    PMID: 29866202DERIVED

  • 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.

    PMID: 29042376DERIVED

MeSH Terms

Conditions

Mental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Swaran P Singh, MD, DM

    Warwick Medical School, University of Warwick, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 28, 2016

First Posted

January 6, 2017

Study Start

October 1, 2015

Primary Completion

January 1, 2017

Study Completion

December 1, 2018

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

IT(1)NL(2)BE(1)CR(1)GB(2)IE(1)FR(1)DE(1)