AzTrials
AzTrials

Mental Health ImpairmentMILESTONENCT03013595

The MILESTONE Study: Improving Transition From Child to Adult Mental Health Care

A study testing TRAM feedback in people with Mental Health Impairment and Mental Health Disorder, run by University of Warwick at 10 sites in 8 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 15 to 18 years
What is being tested?
TRAM feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
10 sitesin 8 countries
Study dates
Oct 2015to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Young person inclusion:
  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 8 countries.

10 sites in 8 countries

Netherlands2 sites

  • Yulius Academy

    Barendrecht

  • Erasmus Medical Centre

    Rotterdam

Other trials in Netherlands

United Kingdom2 sites

  • Warwick Medical School, University of Warwick

    Coventry, CV4 7AL

  • King's College London

    London, SE5 8AF

Other trials in United Kingdom

Belgium1 site

  • Katholieke Universiteit Leuven

    Leuven

Other trials in Belgium

Croatia1 site

  • University Hospital Split

    Split

Other trials in Croatia

France1 site

  • CHRU Montpellier-St Eloi hospital

    Montpellier

Other trials in France

Germany1 site

  • University of Ulm

    Ulm

Other trials in Germany

Ireland1 site

  • University College Dublin

    Dublin

Other trials in Ireland

Italy1 site

  • IRCCS Fatebenefratelli

    Brescia

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
TRAM feedback
Keywords
Mental health, Youth mental health, Adolescent, Health services, Transition, Longitudinal cohort study, Cluster randomised controlled trial, Young adult
Medical subject headings
Mental Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRAM feedbackBehavioural

    Also called Managed transition

Study groups in NCT03013595
Study groupRoleWhat they receive
TRAM feedbackExperimental1. 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.
Receives: Behavioral: TRAM feedback
Usual careNo interventionPatients, 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 15 months

Secondary outcomes (14)

  1. 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)

    Measured: Baseline, 9, 15, and 24 months

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

    The TROM is a questionnaire completed by the young person, parent/carer and clinician

    Measured: Baseline, 9, 15, and 24 months

  3. 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)

    YSR is completed by young people aged 17 years or less; ASR by those 18 years or over

    Measured: Baseline, 9, 15, and 24 months

  4. 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)

    Parent/carer completes CBCL if young person is 17 years or less; ABCL if young person is 18 years or over

    Measured: Baseline, 9, 15, and 24 months

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

    Measured: Baseline, 9, 15, and 24 months

  6. Quality of life assessed by World Health Organisation Quality of Life Assessment (WHOQOLBREF)

    Measured: Baseline, 15, and 24 months

  7. Independent behaviour assessed by Independent Behaviour During Consultation Scale (IBDCS)

    Measured: Baseline, 9, 15, and 24 months, if young person is a current service user

  8. Illness perception assessed by the Brief Illness Perception Questionnaire (BIPQ)

    Measured: Baseline and 24 months

  9. Barriers to care assessed by Barriers to Care (BtC) checklist

    Measured: 9, 15, and 24 months, if young person is no longer a service user

  10. Transition experience and readiness assessed by On Your Own Feet - Transition Experience Scale (OYOF-TES)

    Measured: at 9, 15 or 24 months, completed only once at the first assessment after transition

  11. Adult functioning assessed by Specific Levels of Functioning Scale (SLOF)

    Measured: Baseline and 24 months

  12. Quality Adjusted Life Years (QALYs) assessed by EuroQol generic quality of life questionnaire (EQ-5D-5L)

    Measured: Baseline, 9, 15, and 24 months

  13. Service use assessed by a MILESTONE specific Client Service Receipt Inventory (CSRI)

    Measured: Baseline, 9, 15, and 24 months

  14. Mental health status as measured by Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA - clinician version)

    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.

    Measured: Baseline, 9 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2017 (estimated)
  2. Study startOct 2015
  3. Primary completionJan 2017
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03013595
Sponsor's protocol ID
REC15/WM/0052
Other IDs
ISRCTN83240263
Acronym
MILESTONE
Status last verified
Nov 2017
First submitted
28 Dec 2016
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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. 2026 Mar;82(3):317-329. doi: 10.1002/jclp.70073. Epub 2025 Nov 30.

    PubMed 41319312

  • 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.

    PubMed 41107439

  • 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.

    PubMed 34916319

  • 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.

    PubMed 32580979

  • 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.

    PubMed 32299401

  • 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.

    PubMed 29866202

  • 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.

    PubMed 29042376

Questions about this trial

What is this clinical trial studying?

A study testing TRAM feedback in people with Mental Health Impairment and Mental Health Disorder, run by University of Warwick at 10 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Netherlands, United Kingdom, Belgium, Croatia, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03013595, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in