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临床试验/ISRCTN83240263
ISRCTN83240263已完成未知

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

niversity of Warwick0 个研究点目标入组 844 人开始时间: 2015年7月23日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
844

研究概览

简要总结

2018 Other publications in https://pubmed.ncbi.nlm.nih.gov/29866202/ background, rationale and methodology 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32580979/ TRAM validation (added 29/01/2021) 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32299401/ TRAM and TROM development protocol (added 29/01/2021) 2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/29042376/ protocol (added 29/01/2021) 2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/34916319/ demographic and clinical characteristics (added 20/06/2022) 2021 Results article in https://doi.org/10.1017/S0033291721003901 (added 12/06/2023) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35146551/ Demographic, clinical, and service-use characteristics results (added 03/09/2024)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Young person inclusion:
  • 1. Provides valid written informed consent, or assent, if below the legal age of consent
  • 2. If age is within 1 year of reaching the transition boundary of their CAMHS during the trial recruitment period and (added 23/01/2017) 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
  • 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

排除标准

  • 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

研究者

发起方
niversity of Warwick

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