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

Mental Health Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03013595
• Other study ID #: REC15/WM/0052
• Secondary ID: ISRCTN83240263
• Status: Active, not recruiting
• Phase: N/A
• First received: December 28, 2016
• Last updated: November 15, 2017
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: University of Warwick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 care.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Mental Health Disorder
• Mental Health Impairment

Intervention

Behavioral:
• TRAM feedback

Locations

Country	Name	City	State
Belgium	Katholieke Universiteit Leuven	Leuven
Croatia	University Hospital Split	Split
France	CHRU Montpellier-St Eloi hospital	Montpellier
Germany	University of Ulm	Ulm
Ireland	University College Dublin	Dublin
Italy	IRCCS Fatebenefratelli	Brescia
Netherlands	Yulius Academy	Barendrecht
Netherlands	Erasmus Medical Centre	Rotterdam
United Kingdom	Warwick Medical School, University of Warwick	Coventry
United Kingdom	King's College London	London

Sponsors (13)

Lead Sponsor	Collaborator
University of Warwick	Clinical Hospital Center, Split, Concentris research management gmbh, Erasmus Medical Center, European Union, HealthTracker Ltd, UK, IRCCS Centro San Giovanni di Dio Fatebenefratelli, Katholieke Universiteit Leuven, King's College London, University College Dublin, University Hospital, Montpellier, University of Ulm, Yulius

Countries where clinical trial is conducted

Belgium,  Croatia,  France,  Germany,  Ireland,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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	Baseline, 9, 15, and 24 months
Secondary	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	Baseline, 9, 15, and 24 months
Secondary	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	Baseline, 9, 15, and 24 months
Secondary	Illness severity assessed by Clinical Global Impression Severity (CGIS) scale (CGIseverity)		Baseline, 9, 15, and 24 months
Secondary	Quality of life assessed by World Health Organisation Quality of Life Assessment (WHOQOLBREF)		Baseline, 15, and 24 months
Secondary	Independent behaviour assessed by Independent Behaviour During Consultation Scale (IBDCS)		Baseline, 9, 15, and 24 months, if young person is a current service user
Secondary	Illness perception assessed by the Brief Illness Perception Questionnaire (BIPQ)		Baseline and 24 months
Secondary	Barriers to care assessed by Barriers to Care (BtC) checklist		9, 15, and 24 months, if young person is no longer a service user
Secondary	Transition experience and readiness assessed by On Your Own Feet - Transition Experience Scale (OYOF-TES)		at 9, 15 or 24 months, completed only once at the first assessment after transition
Secondary	Adult functioning assessed by Specific Levels of Functioning Scale (SLOF)		Baseline and 24 months
Secondary	Quality Adjusted Life Years (QALYs) assessed by EuroQol generic quality of life questionnaire (EQ-5D-5L)		Baseline, 9, 15, and 24 months
Secondary	Service use assessed by a MILESTONE specific Client Service Receipt Inventory (CSRI)		Baseline, 9, 15, and 24 months
Secondary	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.	Baseline, 9 months, 24 months