A Biofeedback Intervention for the Prevention of Challenging Behaviour
A Biofeedback Intervention for the Prevention of Challenging Behaviour in People With Acquired Brain Injury
研究概览
详细说明
A multiple baseline "A-B-A" single case experimental design will be adopted with baseline, intervention, and return to baseline phases.
Participants will wear the portable monitoring device with heart rate monitor, pedometer and global positioning system (GPS) functions. A pre-calculated algorithm, developed using machine learning software will be used to predict challenging behaviour episodes 2-4 hours in advance of the event. Recent research has developed a best predictor model with a sensitivity of 82% and specificity of 42%, when averaged across two participants (in press). The device will communicate with a smart phone, via Bluetooth connectivity, when an event has been predicted.
Following enrolment in the study, participants will be randomly assigned to a treatment start time, which will follow from an initial baseline phase. During the baseline phase, participants will wear a commercially available smart watch with physiological monitoring capability, for at least one month in order to gather behaviour frequency data, and associated physiological data; no prompts will be provided. During this period, behavioural and physiological data will be sent to a secure server where a machine learning algorithm will examine the relationships between data streams and 'self-tune' to improve its prediction of challenging behaviour episodes. In the treatment phase, participants and staff will receive a biofeedback prompt in text, or graphic form (e.g. mood light), on the smart watch/connected mobile phone, when an event has been predicted. This will prompt participants to implement a proactive anxiety management strategy, and will prompt staff to support the participant in completing this, if required. The strategy used will be predetermined in the participant's standard care plan e.g. breathing relaxation, reframing the problem, behavioural redirection. Details will be recorded using an adapted version of the Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR), describing the situation in which the biofeedback prompt occurred, participant and staff responses to the biofeedback prompt, and any resulting behaviours, including the occurrence of challenging behaviour. Following the intervention phase, participants will return to a baseline phase for one month, in which no prompts will be provided. Again, details of any challenging behaviour will be recorded via the OAS-MNR.
研究类型
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- participants who have sustained a severe injury to the brain, as determined by length of unconsciousness (greater than 24 hours), a Glasgow Coma Scale of 3 to 8 and a Post Traumatic Amnesia period greater than 1 day
- participants who are resident in the Graham Anderson House, Brain Injury Rehabilitation (BIRT) Unit
- participants presenting with challenging behaviour, during the recruitment period
- participants will NOT be excluded on the basis of comorbid psychiatric disorders or drug/alcohol use, in order to provide conclusions representative of the clinical population
- participants will NOT be excluded on the basis of being unable to provide informed consent, in order to provide conclusions representative of the clinical population
Exclusion Criteria:
- a level of cognitive impairment that would prevent individuals from understanding the feedback obtained via digital or verbal prompts
- participants without the capacity to consent, that do not provide verbal assent to participate in the study
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Biofeedback intervention
Biofeedback prompt in text or graphic form to implement proactive anxiety management strategy, as per standard care plan
|
Anxiety management strategy as per standard care plan
|
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 |
|---|---|---|
|
Number of incidents of challenging behaviour
大体时间:5 months
|
Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)
|
5 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Implementation of anxiety management strategy
大体时间:5 months
|
Number of times anxiety management strategy successfully employed
|
5 months
|
合作者和调查者
调查人员
- 研究主任:Jonathan Evans, BSc PhD、University of Glasgow
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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