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一项针对青少年心理健康服务使用者的队列研究方案,其中包含一项嵌套式整群随机对照试验,以评估管理式过渡在改善从儿童心理健康服务向成人心理健康服务过渡方面的临床效果和成本效益(里程碑研究)。

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).

作者信息

Singh Swaran P, Tuomainen Helena, Girolamo Giovanni de, Maras Athanasios, Santosh Paramala, McNicholas Fiona, Schulze Ulrike, Purper-Ouakil Diane, Tremmery Sabine, Franić Tomislav, Madan Jason, Paul Moli, Verhulst Frank C, Dieleman Gwen C, Warwick Jane, Wolke Dieter, Street Cathy, Daffern Claire, Tah Priya, Griffin James, Canaway Alastair, Signorini Giulia, Gerritsen Suzanne, Adams Laura, O'Hara Lesley, Aslan Sonja, Russet Frédérick, Davidović Nikolina, Tuffrey Amanda, Wilson Anna, Gatherer Charlotte, Walker Leanne

机构信息

Mental Health and Wellbeing, Division of Health Sciences, Warwick Medical School, Universityof Warwick, Coventry, UK.

Psychiatric Epidemiology and Evaluation Unit, Saint John of God Clinical Research Center, Brescia, Italy.

出版信息

BMJ Open. 2017 Oct 16;7(10):e016055. doi: 10.1136/bmjopen-2017-016055.

Abstract

INTRODUCTION

Disruption of care during transition from child and adolescent mental health services (CAMHS) to adult mental health services may adversely affect the health and well-being of service users. The MILESTONE (Managing the Link and Strengthening Transition from Child to Adult Mental Healthcare) study evaluates the longitudinal course and outcomes of adolescents approaching the transition boundary (TB) of their CAMHS and determines the effectiveness of the model of managed transition in improving outcomes, compared with usual care.

METHODS AND ANALYSIS

This is a cohort study with a nested cluster randomised controlled trial. Recruited CAMHS have been randomised to provide either (1) managed transition using the Transition Readiness and Appropriateness Measure score summary as a decision aid, or (2) usual care for young people reaching the TB. Participants are young people within 1 year of reaching the TB of their CAMHS in eight European countries; one parent/carer and a CAMHS clinician for each recruited young person; and adult mental health clinician or other community-based care provider, if young person transitions. The primary outcome is Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) measuring health and social functioning at 15 months postintervention. The secondary outcomes include mental health, quality of life, transition experience and healthcare usage assessed at 9, 15 and 24 months postintervention. With a mean cluster size of 21, a total of 840 participants randomised in a 1:2 intervention to control are required, providing 89% power to detect a difference in HoNOSCA score of 0.30 SD. The addition of 210 recruits for the cohort study ensures sufficient power for studying predictors, resulting in 1050 participants and an approximate 1:3 randomisation.

ETHICS AND DISSEMINATION

The study protocol was approved by the UK National Research Ethics Service (15/WM/0052) and equivalent ethics boards in participating countries. Results will be reported at conferences, in peer-reviewed publications and to all relevant stakeholder groups.

TRIAL REGISTRATION NUMBER

ISRCTN83240263; NCT03013595 (pre-results).

摘要

引言

从儿童和青少年心理健康服务(CAMHS)过渡到成人心理健康服务期间,护理中断可能会对服务使用者的健康和福祉产生不利影响。里程碑(管理儿童到成人心理健康护理的衔接并加强过渡)研究评估了接近其CAMHS过渡边界(TB)的青少年的纵向病程和结局,并确定了与常规护理相比,管理过渡模式在改善结局方面的有效性。

方法与分析

这是一项队列研究,其中嵌套了整群随机对照试验。招募的CAMHS已被随机分配,以提供以下两种服务之一:(1)使用过渡准备和适宜性测量分数摘要作为决策辅助工具进行管理过渡,或(2)为达到TB的年轻人提供常规护理。参与者是八个欧洲国家中距离其CAMHS的TB不到1年的年轻人;为每个招募的年轻人配备一名家长/照顾者和一名CAMHS临床医生;如果年轻人过渡,则配备成人心理健康临床医生或其他社区护理提供者。主要结局是干预后15个月时测量健康和社会功能的《国家儿童和青少年健康结局量表》(HoNOSCA)。次要结局包括干预后9、15和24个月时评估的心理健康、生活质量、过渡经历和医疗保健使用情况。平均整群大小为21,总共需要840名参与者按1:2的比例随机分配到干预组和对照组,这将提供89%的检验效能,以检测HoNOSCA分数相差0.30标准差。队列研究额外增加210名招募者可确保有足够的检验效能来研究预测因素,从而有1050名参与者,并实现约1:3的随机分配。

伦理与传播

该研究方案已获得英国国家研究伦理服务机构(15/WM/0052)以及参与国同等伦理委员会的批准。研究结果将在会议上、同行评审的出版物中以及向所有相关利益相关者群体报告。

试验注册号

ISRCTN83240263;NCT03013595(预结果)。

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