A Feasibility Trial of Power Up
2016年12月6日 更新者：University College, London
A Feasibility Trial of Power Up: A Smartphone App to Support Young People to Make Shared Decisions in Therapy
There is an increasing demand for digital tools to empower young people with mental health difficulties (NHS England, 2015). Digital information, advice and mood tracking tools are increasingly being used to support child mental health. Evidence suggests that young people want to be active participants in their care and involved in decisions about their treatment. However, there is a lack of digital shared decision making tools available to support young people in Child and Adolescent Mental Health Services (CAMHS). This study aims to develop Power Up, a smartphone app to empower young people in CAMHS to make their voice heard and to participate more in decisions around their care.
The project will involve two phases:
- Development Phase -Developing Power Up according to the views and ideas expressed by young people, their parents/ carers, and clinicians in Patient and Public Involvement (PPI) sessions. -Conducting interviews and focus groups with 10 young people in CAMHS, 10 parents/ carers and 10 clinicians to review the acceptability of the content and format of Power Up.
- Feasibility testing Phase -Conducting a feasibility trial with 120 young people with emotional difficulties, aged 11-19 years, from three London CAMHS. 60 young people will receive treatment as usual and 60 will use Power Up alongside treatment as usual. Participant's ratings of empowerment, activation, and symptoms will be measured soon after their referral to the service. The same measures plus shared decision making questionnaires will be administered three months later.
The findings will inform the planning of a prospective cluster controlled trial. More broadly this trial will contribute an understanding of the feasibility and acceptability of developing and implementing a shared decision making app into CAMHS.
研究概览
研究类型
介入性
注册 (预期的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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London、英国、E1 5NF
- 招聘中
- East London NHS Foundation Trust
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接触：
- Percy Aggett
- 电话号码：2400 020 7426 2375
- 邮箱：Percy.Aggett@elft.nhs.uk
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London、英国、IG11 7LZ
- 招聘中
- North East London NHS Foundation Trust
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接触：
- Vivienne Okoh
- 电话号码：53261 0300 555 1035
- 邮箱：Vivienne.Okoh@nelft.nhs.uk
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London、英国、NW3 5BA
- 招聘中
- The Tavistock and Portman NHS Foundation Trust
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接触：
- Emilios Lemoniatis
- 电话号码：020 8938 2429
- 邮箱：ELemoniatis@tavi-port.nhs.uk
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首席研究员：
- Emilios Lemoniatis
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
11年 至 19年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Recently been referred to CAMHS (pre - first appointment)
- Presenting with emotional difficulties
- Clinician will have confirmed that the young person does not have any vulnerability which would make taking part in the study inappropriate to their context
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control Phase (No Power Up)
60 young people will receive CAMHS treatment as usual.
Measures of empowerment, activation, and symptoms will be completed by participants soon after their referral to the service.
The same measures plus shared decision making questionnaires will be administered three months later.
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实验性的：Intervention Phase (Power Up)
60 young people use Power Up alongside CAMHS treatment as usual.
Measures of empowerment, activation, and symptoms will be completed by participants soon after their referral to the service.
The same measures plus shared decision making questionnaires and a Power Up feedback form will be administered three months later.
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Smartphone phone app
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Shared Decision Making Questionnaire - 9 (SDM Q-9)
大体时间：3 months
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This will be completed by young people at time two (three months into therapy).
The SDM Q-9 is a nine item patient reported shared decision making questionnaire.
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3 months
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CollaboRATE
大体时间：3 months
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This will be completed by young people at time two (three months into therapy).
CollaboRATE is a three item patient reported shared decision making measure.
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3 months
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Experience of Service Questionnaire (ESQ)
大体时间：3 months
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Four items from this questionnaire will be completed by young people at time two (three months into therapy) as a proxy measure of shared decision making.
The ESQ is a self-completion questionnaire that assesses children and young people's views of services with respect to accessibility, humanity of care, organisation of care and environment.
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3 months
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Dyadic OPTION scale
大体时间：3 months
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This will be completed by clinicians at time two (three months into therapy).
The Dyadic OPTION scale is a 12- item instrument to measure the extent to which patients have been involved in shared decision making from the viewpoint of the clinician.
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient Activation Measure - Mental Health (PAM - MH)
大体时间：3 months
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The PAM - MH will be completed by young people at time one (beginning of therapy) and time two (three months into therapy).
The PAM - MH is a patient reported tool for measuring engagement in mental healthcare.
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3 months
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Strengths and Difficulties questionnaire (SDQ)
大体时间：3 months
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The SDQ will be completed by young people at time one (beginning of therapy) and time two (three months into therapy).
The SDQ is a self-report behavioural screening questionnaire for children and adolescents measuring symptoms and functioning.
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3 months
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Youth Efficacy / Empowerment Scale - Mental Health (YES - MH)
大体时间：3 months
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The YES -MH will be completed by young people at time one (beginning of therapy) and time two (three months into therapy).
The YES - MH assesses youth perceptions of efficacy with respect to managing their own mental health condition ('Self'), managing their own services and supports ('Service'), and using their experience and knowledge to help peers and improve service systems ('System').
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3 months
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Client Receipt of Services Inventory (CSRI) - Children's Version.
大体时间：3 months
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The CSRI will be completed by parents at time one (beginning of therapy) and time two (three months into therapy).
The CSRI provides information on service utilisation, as reported by the main carer of the child in the family.
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3 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Did Not Attends (DNAs)
大体时间：3 months
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Number of young person DNAs will be reported by the clinician.
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3 months
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Number of sessions attended
大体时间：3 months
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The number of sessions attended by the young person will be reported by the clinician.
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3 months
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Type of therapy / intervention received
大体时间：3 months
|
The type of therapy / intervention received by the young person will be reported by the clinician.
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3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Miranda Wolpert, Professor、UCL & Anaa Freud National Centre for Children and Families
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年9月1日
初级完成 (预期的)
2017年8月1日
研究完成 (预期的)
2017年9月1日
研究注册日期
首次提交
2016年10月12日
首先提交符合 QC 标准的
2016年12月6日
首次发布 (估计)
2016年12月9日
研究记录更新
最后更新发布 (估计)
2016年12月9日
上次提交的符合 QC 标准的更新
2016年12月6日
最后验证
2016年10月1日
更多信息
与本研究相关的术语
其他研究编号
- 16/0087
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Power Up的临床试验
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Shannon E. Sauer-ZavalaNational Institute of Mental Health (NIMH)主动，不招人
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Montefiore Medical CenterHealth Resources and Services Administration (HRSA)完全的
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University of Illinois at ChicagoCongressionally Directed Medical Research Programs招聘中
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Mary LacyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)主动，不招人
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University of MichiganNational Institute on Drug Abuse (NIDA); Brown University; Pennington Biomedical Research Center; Oregon Research Institute 和其他合作者招聘中