Condition category
Mental and Behavioural Disorders
Date applied
22/07/2015
Date assigned
23/07/2015
Last edited
03/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
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.

Who can participate?
Young people aged under the regular care of a CAMHS and are reaching transition age (usually 16-18 years old).

What does the study involve?
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.

What are the possible benefits and risks of participating?
There are no benefits or risks associated with taking part in the study.

Where is the study run from?
University of Warwick (UK)

When is the study starting and how long is it expected to run for?
September 2015 to January 2019

Who is funding the study?
Seventh Framework Programme (Belgium)

Who is the main contact?
Dr Helena Tuomainen

Trial website

http://www.milestone-transitionstudy.eu/

Contact information

Type

Public

Primary contact

Dr Helena Tuomainen

ORCID ID

Contact details

University of Warwick
Gibbet Hill Road
Coventry
West Midlands
CV4 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19173

Study information

Scientific 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

Acronym

MILESTONE (ManagIng the Link and Strengthening TransitiON from child to adult mental health carE)

Study hypothesis

Do young people reaching the transition boundary of their child and adolescent mental health service benefit from the implementation of a model of managed transition regarding their health and social outcomes, and transition to adult roles, as compared to usual care?

Ethics approval

NRES Committee West Midlands – South Birmingham 24/02/2015, Ref: 15/WM/0052

Study design

Both; Interventional and Observational; Design type: Process of Care, Cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Children, Mental Health; Subtopic: All Diagnoses, Psychosis; Disease: Psychosis, All Diseases

Intervention

Intervention arm: The model of managed transition includes:
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.

The control arm: 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

Behavioural

Phase

Drug names

Primary outcome measures

Mental health status (need for care) will be measured by the use of the clinician’s version of the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) at baseline, 9, 15, and 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.

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) at baseline, 9, 15, and 24 months.
2. Transition outcome assessed by the Transition Outcome Measure (TROM) (young person, parent/carer, clinician) at 9, 15, and 24 months.
3. Self-reported and parent/carer reported psychopathology assessed by The Development and Well-being Assessment (DAWBA) (Young person, parent/carer) and clinical diagnosis (clinician) at baseline and 24 months.
4. Emotional and behavioural problems assessed by the ASEBA Youth Self Report (YSR)/Adult Self Report (ASR) questionnaires (young person) and CBCL/ABCL questionnaires (parent/carer) at baseline, 9, 15, and 24 months.
5. Illness severity assessed by Clinical Global Impression Severity scale (CGIseverity) (clinician) at baseline, 9, 15, and 24 months
6. Quality of life assessed by WHOQOLBREF (young person) at baseline and 24 months.
7. Independent behaviour assessed by Independent Behaviour During Consultation Scale (IBDCS) (young person) at 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) (young person) at baseline and 24 months.
9. Barriers to care assessed by Barriers to Care (BtC) checklist (young person) at 9, 15, and 24 months, if young person is no longer a service user.
10. Transition experience and readiness assessed by OYOF-TES – Transition Experience Scale (young person, parent/carer) at 9 or 18 months, completed only once at the first assessment after transition
11. Adult functioning assessed by Specific Levels of Functioning Scale (SLOF) (parent/carer) at baseline and 24 months.
12. Cost-effectiveness assessed by EQ-5D-5L (young person) at baseline, 9, 15, and 24 months
13. Service use assessed by a MILESTONE specific Client Service Receipt Inventory (CSRI) at baseline, 9, 15, and 27 months (young person) and 9 and 24 months (parent/carer).

All measures are completed by online survey.

Overall trial start date

01/02/2014

Overall trial end date

31/01/2019

Reason abandoned

Eligibility

Participant 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
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

Parent/carer inclusion:
1. Only one parent/carer per young person can be recruited into the study, the aim being to engage the same individual throughout the study. If the latter is not possible, then the aim is to involve another parent/carer;
2. If the young person doesn’t live with his/her biological parent/s, then his/her carer will be involved. A carer may be the legal guardian or a partner or an older adult sibling, or another individual living with and/or providing regular support to the young person;
3. For young people under the legal age of consent, the parent/carer has to be the legal guardian of the young person;
4. Young person consents to parent/carer participation;
5. Parent/carer provides a valid written informed consent.

Clinician/care provider inclusion:
1. Is responsible for the main care for young person at CAMHS (and AMHS or other relevant service provider, if referral is made)
2. Provides a valid written informed consent

Participant type

All

Age group

Mixed

Gender

Both

Target number of participants

Planned Sample Size: 3000; UK Sample Size: 450; Description: UK sample size will be 150 young people +150 parents/carers+ (up to)150 clinicians + (unknown, <150) referral clinicians. So ballpark 450 - 600.This translates to the following total figures in the 8 European countries: 1000 CAMHS service users (young people), 1000 parents/carers up to 1000 CAMHS clinicians and AMHS clinicians/care provider.

Participant exclusion criteria

Young person exclusion:
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

Parent or carer refusal or inability to participate him/herself in assessments may prevent the participation of the service user, yet this will depend on the individual country’s legal and ethical situation. In the UK, young people over the age of 16 will be able to take part even if their parent/carer does not take part.

Parent/carer exclusion:
1. A parent/carer who does not live with and/or provide regular support to young person
2. Young person does not provide consent for parent/carer participation
3. Parent/carer does not provide a valid written consent
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

Clinician/care provider exclusion:
1. Does not provide care for young person, or only provides intermittent care at CAMHS (and AMHS or other relevant service provider, if referral is made)
2. Does not provide a valid written informed consent

Recruitment start date

01/09/2015

Recruitment end date

31/12/2016

Locations

Countries of recruitment

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

Trial participating centre

University of Warwick
Gibbet Hill Road
Coventry, West Midlands
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick

Sponsor details

Gibbet Hill Road
Coventry
Wast Midlands
CV4 7AL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Seventh Framework Programme

Alternative name(s)

EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

There will be three kinds of papers emerging from the MILESTONE project:
Type I: the main paper, related to the primary aim/task of an individual work package.
Type II: further papers using main data set, exploring subsidiary hypotheses.
Type III: papers that explore questions of interest to individual members, or hypotheses not central to the primary objectives of the programme

Key papers linked with trial:
1. Protocol paper
2. Main trial paper on the effectiveness of managed intervention on the primary outcome comparing intervention and control arms
3. Trial paper (s) on effectiveness of managed intervention on the secondary outcomes comparing intervention and control arms
4. Baseline predictors of good and poor transition
5. Economic evaluation of an intervention to strengthen transition from child to adult mental health care.
6. Long term outcomes of the longitudinal cohort (not the outcomes of the cRCT)

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/11/2016: Changed outcome measure timepoints from 9, 18 and 27 months to 9, 15 and 24 months. Changed recruitment end date from 30/04/2016 to 31/12/2016