- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03013595
The MILESTONE Study: Improving Transition From Child to Adult Mental Health Care (MILESTONE)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Leuven, Belgium
- Katholieke Universiteit Leuven
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Split, Croatia
- University Hospital Split
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Montpellier, France
- CHRU Montpellier-St Eloi hospital
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Ulm, Germany
- University of Ulm
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Dublin, Ireland
- University College Dublin
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Brescia, Italy
- IRCCS Fatebenefratelli
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Barendrecht, Netherlands
- Yulius Academy
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Rotterdam, Netherlands
- Erasmus Medical Centre
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Coventry, United Kingdom, CV4 7AL
- Warwick Medical School, University of Warwick
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London, United Kingdom, SE5 8AF
- King's College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TRAM feedback
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Other Names:
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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15 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
Time Frame: Baseline, 9, 15, and 24 months
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Baseline, 9, 15, and 24 months
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Transition outcome assessed by the Transition Related Outcome Measure (TROM) questionnaire
Time Frame: Baseline, 9, 15, and 24 months
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The TROM is a questionnaire completed by the young person, parent/carer and clinician
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Baseline, 9, 15, and 24 months
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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)
Time Frame: Baseline, 9, 15, and 24 months
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YSR is completed by young people aged 17 years or less; ASR by those 18 years or over
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Baseline, 9, 15, and 24 months
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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)
Time Frame: Baseline, 9, 15, and 24 months
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Parent/carer completes CBCL if young person is 17 years or less; ABCL if young person is 18 years or over
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Baseline, 9, 15, and 24 months
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Illness severity assessed by Clinical Global Impression Severity (CGIS) scale (CGIseverity)
Time Frame: Baseline, 9, 15, and 24 months
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Baseline, 9, 15, and 24 months
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Quality of life assessed by World Health Organisation Quality of Life Assessment (WHOQOLBREF)
Time Frame: Baseline, 15, and 24 months
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Baseline, 15, and 24 months
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Independent behaviour assessed by Independent Behaviour During Consultation Scale (IBDCS)
Time Frame: Baseline, 9, 15, and 24 months, if young person is a current service user
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Baseline, 9, 15, and 24 months, if young person is a current service user
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Illness perception assessed by the Brief Illness Perception Questionnaire (BIPQ)
Time Frame: Baseline and 24 months
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Baseline and 24 months
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Barriers to care assessed by Barriers to Care (BtC) checklist
Time Frame: 9, 15, and 24 months, if young person is no longer a service user
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9, 15, and 24 months, if young person is no longer a service user
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Transition experience and readiness assessed by On Your Own Feet - Transition Experience Scale (OYOF-TES)
Time Frame: at 9, 15 or 24 months, completed only once at the first assessment after transition
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at 9, 15 or 24 months, completed only once at the first assessment after transition
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Adult functioning assessed by Specific Levels of Functioning Scale (SLOF)
Time Frame: Baseline and 24 months
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Baseline and 24 months
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Quality Adjusted Life Years (QALYs) assessed by EuroQol generic quality of life questionnaire (EQ-5D-5L)
Time Frame: Baseline, 9, 15, and 24 months
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Baseline, 9, 15, and 24 months
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Service use assessed by a MILESTONE specific Client Service Receipt Inventory (CSRI)
Time Frame: Baseline, 9, 15, and 24 months
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Baseline, 9, 15, and 24 months
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Mental health status as measured by Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA - clinician version)
Time Frame: Baseline, 9 months, 24 months
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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.
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Baseline, 9 months, 24 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Swaran P Singh, MD, DM, Warwick Medical School, University of Warwick, UK
Publications and helpful links
General Publications
- 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. Erratum In: BMC Psychiatry. 2018 Sep 14;18(1):295.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC15/WM/0052
- ISRCTN83240263 (Registry Identifier: ISRCTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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