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

Primary Purpose

Mental Health Impairment, Mental Health Disorder

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TRAM feedback
Sponsored by
University of Warwick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Health Impairment focused on measuring Mental health, Youth mental health, Adolescent, Health services, Transition, Longitudinal cohort study, Cluster randomised controlled trial, Young adult

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Katholieke Universiteit Leuven
  • University Hospital Split
  • CHRU Montpellier-St Eloi hospital
  • University of Ulm
  • University College Dublin
  • IRCCS Fatebenefratelli
  • Yulius Academy
  • Erasmus Medical Centre
  • Warwick Medical School, University of Warwick
  • King's College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TRAM feedback

Usual care

Arm Description

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. 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. 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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
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
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
Illness severity assessed by Clinical Global Impression Severity (CGIS) scale (CGIseverity)
Quality of life assessed by World Health Organisation Quality of Life Assessment (WHOQOLBREF)
Independent behaviour assessed by Independent Behaviour During Consultation Scale (IBDCS)
Illness perception assessed by the Brief Illness Perception Questionnaire (BIPQ)
Barriers to care assessed by Barriers to Care (BtC) checklist
Transition experience and readiness assessed by On Your Own Feet - Transition Experience Scale (OYOF-TES)
Adult functioning assessed by Specific Levels of Functioning Scale (SLOF)
Quality Adjusted Life Years (QALYs) assessed by EuroQol generic quality of life questionnaire (EQ-5D-5L)
Service use assessed by a MILESTONE specific Client Service Receipt Inventory (CSRI)
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.

Full Information

First Posted
December 28, 2016
Last Updated
November 15, 2017
Sponsor
University of Warwick
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
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1. Study Identification

Unique Protocol Identification Number
NCT03013595
Brief Title
The MILESTONE Study: Improving Transition From Child to Adult Mental Health Care
Acronym
MILESTONE
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 Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Warwick
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Impairment, Mental Health Disorder
Keywords
Mental health, Youth mental health, Adolescent, Health services, Transition, Longitudinal cohort study, Cluster randomised controlled trial, Young adult

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TRAM feedback
Arm Type
Experimental
Arm Description
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. 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. 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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TRAM feedback
Other Intervention Name(s)
Managed transition
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
15 months
Secondary Outcome Measure Information:
Title
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
Title
Transition outcome assessed by the Transition Related Outcome Measure (TROM) questionnaire
Description
The TROM is a questionnaire completed by the young person, parent/carer and clinician
Time Frame
Baseline, 9, 15, and 24 months
Title
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)
Description
YSR is completed by young people aged 17 years or less; ASR by those 18 years or over
Time Frame
Baseline, 9, 15, and 24 months
Title
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)
Description
Parent/carer completes CBCL if young person is 17 years or less; ABCL if young person is 18 years or over
Time Frame
Baseline, 9, 15, and 24 months
Title
Illness severity assessed by Clinical Global Impression Severity (CGIS) scale (CGIseverity)
Time Frame
Baseline, 9, 15, and 24 months
Title
Quality of life assessed by World Health Organisation Quality of Life Assessment (WHOQOLBREF)
Time Frame
Baseline, 15, and 24 months
Title
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
Title
Illness perception assessed by the Brief Illness Perception Questionnaire (BIPQ)
Time Frame
Baseline and 24 months
Title
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
Title
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
Title
Adult functioning assessed by Specific Levels of Functioning Scale (SLOF)
Time Frame
Baseline and 24 months
Title
Quality Adjusted Life Years (QALYs) assessed by EuroQol generic quality of life questionnaire (EQ-5D-5L)
Time Frame
Baseline, 9, 15, and 24 months
Title
Service use assessed by a MILESTONE specific Client Service Receipt Inventory (CSRI)
Time Frame
Baseline, 9, 15, and 24 months
Title
Mental health status as measured by Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA - clinician version)
Description
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.
Time Frame
Baseline, 9 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swaran P Singh, MD, DM
Organizational Affiliation
Warwick Medical School, University of Warwick, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katholieke Universiteit Leuven
City
Leuven
Country
Belgium
Facility Name
University Hospital Split
City
Split
Country
Croatia
Facility Name
CHRU Montpellier-St Eloi hospital
City
Montpellier
Country
France
Facility Name
University of Ulm
City
Ulm
Country
Germany
Facility Name
University College Dublin
City
Dublin
Country
Ireland
Facility Name
IRCCS Fatebenefratelli
City
Brescia
Country
Italy
Facility Name
Yulius Academy
City
Barendrecht
Country
Netherlands
Facility Name
Erasmus Medical Centre
City
Rotterdam
Country
Netherlands
Facility Name
Warwick Medical School, University of Warwick
City
Coventry
ZIP/Postal Code
CV4 7AL
Country
United Kingdom
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34916319
Citation
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.
Results Reference
derived
PubMed Identifier
32580979
Citation
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.
Results Reference
derived
PubMed Identifier
32299401
Citation
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.
Results Reference
derived
PubMed Identifier
29866202
Citation
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.
Results Reference
derived
PubMed Identifier
29042376
Citation
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.
Results Reference
derived

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

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