We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03013595
Recruitment Status : Unknown
Verified November 2017 by Swaran Singh, University of Warwick.
Recruitment status was:  Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
European Union
IRCCS Centro San Giovanni di Dio Fatebenefratelli
King's College London
University Hospital, Montpellier
Yulius
University of Ulm
KU Leuven
University College Dublin
Clinical Hospital Center, Split
HealthTracker Ltd, UK
Erasmus Medical Center
Concentris research management gmbh
Information provided by (Responsible Party):
Swaran Singh, University of Warwick

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Mental Health Impairment Mental Health Disorder Behavioral: TRAM feedback Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
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 Start Date : October 2015
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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.
 Behavioral: TRAM feedback
Other Name: Managed transition
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 [ Time Frame: 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.


Secondary Outcome Measures :
  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) [ Time Frame: Baseline, 9, 15, and 24 months ]
  2. Transition outcome assessed by the Transition Related Outcome Measure (TROM) questionnaire [ Time Frame: Baseline, 9, 15, and 24 months ]
    The TROM is a questionnaire completed by the young person, parent/carer and clinician

  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) [ Time Frame: Baseline, 9, 15, and 24 months ]
    YSR is completed by young people aged 17 years or less; ASR by those 18 years or over

  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) [ Time Frame: Baseline, 9, 15, and 24 months ]
    Parent/carer completes CBCL if young person is 17 years or less; ABCL if young person is 18 years or over

  5. Illness severity assessed by Clinical Global Impression Severity (CGIS) scale (CGIseverity) [ Time Frame: Baseline, 9, 15, and 24 months ]
  6. Quality of life assessed by World Health Organisation Quality of Life Assessment (WHOQOLBREF) [ Time Frame: Baseline, 15, and 24 months ]
  7. 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 ]
  8. Illness perception assessed by the Brief Illness Perception Questionnaire (BIPQ) [ Time Frame: Baseline and 24 months ]
  9. 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 ]
  10. 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 ]
  11. Adult functioning assessed by Specific Levels of Functioning Scale (SLOF) [ Time Frame: Baseline and 24 months ]
  12. Quality Adjusted Life Years (QALYs) assessed by EuroQol generic quality of life questionnaire (EQ-5D-5L) [ Time Frame: Baseline, 9, 15, and 24 months ]
  13. Service use assessed by a MILESTONE specific Client Service Receipt Inventory (CSRI) [ Time Frame: 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) [ Time Frame: Baseline, 9 months, 24 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013595


Locations
Layout table for location information
Belgium
Katholieke Universiteit Leuven
Leuven, Belgium
Croatia
University Hospital Split
Split, Croatia
France
CHRU Montpellier-St Eloi hospital
Montpellier, France
Germany
University of Ulm
Ulm, Germany
Ireland
University College Dublin
Dublin, Ireland
Italy
IRCCS Fatebenefratelli
Brescia, Italy
Netherlands
Yulius Academy
Barendrecht, Netherlands
Erasmus Medical Centre
Rotterdam, Netherlands
United Kingdom
Warwick Medical School, University of Warwick
Coventry, United Kingdom, CV4 7AL
King's College London
London, United Kingdom, SE5 8AF
Sponsors and Collaborators
University of Warwick
European Union
IRCCS Centro San Giovanni di Dio Fatebenefratelli
King's College London
University Hospital, Montpellier
Yulius
University of Ulm
KU Leuven
University College Dublin
Clinical Hospital Center, Split
HealthTracker Ltd, UK
Erasmus Medical Center
Concentris research management gmbh
Investigators
Layout table for investigator information
Principal Investigator: Swaran P Singh, MD, DM Warwick Medical School, University of Warwick, UK
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.

Layout table for additonal information
Responsible Party: Swaran Singh, Professor, University of Warwick
ClinicalTrials.gov Identifier: NCT03013595    
Other Study ID Numbers: REC15/WM/0052
ISRCTN83240263 ( Registry Identifier: ISRCTN )
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by Swaran Singh, University of Warwick:
Mental health
Youth mental health
Adolescent
Health services
 Transition
Longitudinal cohort study
Cluster randomised controlled trial
Young adult
Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders