<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03013595</url>
  </required_header>
  <id_info>
    <org_study_id>REC15/WM/0052</org_study_id>
    <secondary_id>ISRCTN83240263</secondary_id>
    <nct_id>NCT03013595</nct_id>
  </id_info>
  <brief_title>The MILESTONE Study: Improving Transition From Child to Adult Mental Health Care</brief_title>
  <acronym>MILESTONE</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Warwick</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Union</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IRCCS Centro San Giovanni di Dio Fatebenefratelli</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yulius</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ulm</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College Dublin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinical Hospital Center, Split</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HealthTracker Ltd, UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Concentris research management gmbh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Warwick</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the longitudinal health and social outcomes of adolescent mental health&#xD;
      service users who are at the transition boundary of their child and adolescent mental health&#xD;
      service, and whether the implementation of a model of managed transition at the service&#xD;
      boundary benefits them, as compared to usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MILESTONE study focuses on the period when young people attending a children and&#xD;
      adolescents mental health service (CAMHS) need to move on, or &quot;transition&quot;, to an adult&#xD;
      mental health service (AMHS), if they still require care or treatment. We know from other&#xD;
      research that this transition is not always properly managed and that improving the&#xD;
      transition process can have a positive impact on the health and well-being of young people in&#xD;
      this position. We want to evaluate what impact the different transition experiences have on&#xD;
      young people's health and well-being, and whether the process of Managed Transition has any&#xD;
      benefits as compared to usual care.&#xD;
&#xD;
      The MILESTONE study is run in eight European countries (UK, Ireland, Belgium, Holland,&#xD;
      France, Germany, Italy and Croatia). CAMHS in the study regions are selected to provide the&#xD;
      young people in their care that are reaching transition age either usual care or a novel&#xD;
      service called &quot;Managed Transition&quot;, which includes the use of a new decision support tool,&#xD;
      the Transition Readiness and Appropriateness Measure (TRAM). This should help with decision&#xD;
      making and enable better transitions by identifying cases for whom transition from CAMHS to&#xD;
      AMHS is advisable and appropriate, or who can be safely discharged or referred to a community&#xD;
      based service. CAMHS are randomly assigned to provide the intervention of Managed Transition&#xD;
      or usual care. The health and well-being of the young people attending these services is&#xD;
      assessed at the start of the study and then followed-up for 24 months to see whether they&#xD;
      transition to AMHS or are discharged or referred to some other service.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2015</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>15 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>Baseline, 9, 15, and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transition outcome assessed by the Transition Related Outcome Measure (TROM) questionnaire</measure>
    <time_frame>Baseline, 9, 15, and 24 months</time_frame>
    <description>The TROM is a questionnaire completed by the young person, parent/carer and clinician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>Baseline, 9, 15, and 24 months</time_frame>
    <description>YSR is completed by young people aged 17 years or less; ASR by those 18 years or over</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <time_frame>Baseline, 9, 15, and 24 months</time_frame>
    <description>Parent/carer completes CBCL if young person is 17 years or less; ABCL if young person is 18 years or over</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illness severity assessed by Clinical Global Impression Severity (CGIS) scale (CGIseverity)</measure>
    <time_frame>Baseline, 9, 15, and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by World Health Organisation Quality of Life Assessment (WHOQOLBREF)</measure>
    <time_frame>Baseline, 15, and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Independent behaviour assessed by Independent Behaviour During Consultation Scale (IBDCS)</measure>
    <time_frame>Baseline, 9, 15, and 24 months, if young person is a current service user</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illness perception assessed by the Brief Illness Perception Questionnaire (BIPQ)</measure>
    <time_frame>Baseline and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers to care assessed by Barriers to Care (BtC) checklist</measure>
    <time_frame>9, 15, and 24 months, if young person is no longer a service user</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transition experience and readiness assessed by On Your Own Feet - Transition Experience Scale (OYOF-TES)</measure>
    <time_frame>at 9, 15 or 24 months, completed only once at the first assessment after transition</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adult functioning assessed by Specific Levels of Functioning Scale (SLOF)</measure>
    <time_frame>Baseline and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality Adjusted Life Years (QALYs) assessed by EuroQol generic quality of life questionnaire (EQ-5D-5L)</measure>
    <time_frame>Baseline, 9, 15, and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Service use assessed by a MILESTONE specific Client Service Receipt Inventory (CSRI)</measure>
    <time_frame>Baseline, 9, 15, and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental health status as measured by Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA - clinician version)</measure>
    <time_frame>Baseline, 9 months, 24 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Mental Health Impairment</condition>
  <condition>Mental Health Disorder</condition>
  <arm_group>
    <arm_group_label>TRAM feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The completion of the &quot;Transition Readiness and Appropriateness Measure&quot; (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.&#xD;
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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TRAM feedback</intervention_name>
    <arm_group_label>TRAM feedback</arm_group_label>
    <other_name>Managed transition</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Young person inclusion:&#xD;
&#xD;
               1. Provides valid written informed consent, or assent, if below the legal age of&#xD;
                  consent&#xD;
&#xD;
               2. If age is within one year of reaching the transition boundary of their CAMHS&#xD;
                  during the trial recruitment period, and, in exceptional cases, not more than 3&#xD;
                  months older than the transition boundary, if a decision about transition has not&#xD;
                  yet been made&#xD;
&#xD;
               3. Has a mental disorder defined by DSM-IV-TR, DSM-5 or ICD 10/11, or is under the&#xD;
                  regular care of CAMHS (if not yet diagnosed)&#xD;
&#xD;
               4. Has an IQ ≥ 70 as ascertained by previous standardised assessment or diagnosed by&#xD;
                  clinician, or no indication of intellectual impairment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Does not provide valid written informed consent, or assent, if below the legal age&#xD;
             of consent 2. Is younger than a year before the transition boundary of their CAMHS 3.&#xD;
             Has intellectual impairment (IQ &lt;70) as ascertained by previous standardised&#xD;
             assessment or diagnosed by clinician (if no data on intellectual functioning are&#xD;
             available [because it has never been assessed] then care coordinators will be asked to&#xD;
             make a clinical judgement on intellectual impairment before baseline assessment takes&#xD;
             place) 4. If not able to (or expected not to be able to) complete the questionnaires&#xD;
             due to severe physical disabilities or language problems, even with assistance from&#xD;
             family members or research assistant 5. Service user in a secure forensic institution&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Swaran P Singh, MD, DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Warwick Medical School, University of Warwick, UK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Katholieke Universiteit Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Split</name>
      <address>
        <city>Split</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Montpellier-St Eloi hospital</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ulm</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College Dublin</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Fatebenefratelli</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yulius Academy</name>
      <address>
        <city>Barendrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Centre</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Warwick Medical School, University of Warwick</name>
      <address>
        <city>Coventry</city>
        <zip>CV4 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College London</name>
      <address>
        <city>London</city>
        <zip>SE5 8AF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Croatia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>November 15, 2017</last_update_submitted>
  <last_update_submitted_qc>November 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Warwick</investigator_affiliation>
    <investigator_full_name>Swaran Singh</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Mental health</keyword>
  <keyword>Youth mental health</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Health services</keyword>
  <keyword>Transition</keyword>
  <keyword>Longitudinal cohort study</keyword>
  <keyword>Cluster randomised controlled trial</keyword>
  <keyword>Young adult</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03013595
org study id: REC15/WM/0052
secondary id: ISRCTN83240263
nct id: NCT03013595
lead sponsor: 
collaborator: 
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has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Care Provider)
measure: 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
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.
measure: 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
measure: Transition outcome assessed by the Transition Related Outcome Measure (TROM) questionnaire
time frame: Baseline, 9, 15, and 24 months
description: The TROM is a questionnaire completed by the young person, parent/carer and clinician
measure: 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
description: YSR is completed by young people aged 17 years or less; ASR by those 18 years or over
measure: 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
description: Parent/carer completes CBCL if young person is 17 years or less; ABCL if young person is 18 years or over
measure: Illness severity assessed by Clinical Global Impression Severity (CGIS) scale (CGIseverity)
time frame: Baseline, 9, 15, and 24 months
measure: Quality of life assessed by World Health Organisation Quality of Life Assessment (WHOQOLBREF)
time frame: Baseline, 15, and 24 months
measure: 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
measure: Illness perception assessed by the Brief Illness Perception Questionnaire (BIPQ)
time frame: Baseline and 24 months
measure: 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
measure: 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
measure: Adult functioning assessed by Specific Levels of Functioning Scale (SLOF)
time frame: Baseline and 24 months
measure: Quality Adjusted Life Years (QALYs) assessed by EuroQol generic quality of life questionnaire (EQ-5D-5L)
time frame: Baseline, 9, 15, and 24 months
measure: Service use assessed by a MILESTONE specific Client Service Receipt Inventory (CSRI)
time frame: Baseline, 9, 15, and 24 months
measure: 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
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.
arm group label: TRAM feedback
arm group type: Experimental
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 group label: Usual care
arm group type: No Intervention
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: TRAM feedback
arm group label: TRAM feedback
other name: Managed transition
criteria: 
gender: All
minimum age: 15 Years
maximum age: 18 Years
healthy volunteers: No
last name: Swaran P Singh, MD, DM
role: Principal Investigator
affiliation: Warwick Medical School, University of Warwick, UK
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
country: Belgium
country: Croatia
country: France
country: Germany
country: Ireland
country: Italy
country: Netherlands
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Warwick
investigator full name: Swaran Singh
investigator title: Professor
mesh term: Mental Disorders