A RCT Comparing the Effects of Providing Clinicians and Patients With the Results of an Objective Measure of Activity and Attention (QbTest) Versus Usual Care on Diagnostic and Treatment Decision Making in Children and Young People With ADHD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 18
- 主要终点
- Number of clinic appointments until correct diagnosis confirmed
研究概览
简要总结
Attention Deficit/Hyperactivity Disorder (ADHD)is one of the most common mental health disorders of childhood. Children with ADHD often have poor attention, are restless and hyperactive and show impulsive behaviour.
It is important to detect ADHD so young people can have access to appropriate clinical interventions.
One of the most common ways ADHD is assessed is through the clinician's opinion; however, this can vary between clinicians and is thought to be one reason why ADHD may be mis-diagnosed. Using a more objective computer tasks may help improve our understanding of ADHD. One computer task is the QbTest.
The test presents different symbols to the child, and the child has to respond by pressing a button only when a target symbol appears. The test measures the child's attention, impulsivity and movement whilst doing this task.
Although the test is thought to be a valid measure, more research needs to be conducted on this measure to see whether it helps clinicians decision making.
To see whether this test helps clinicians make a diagnosis of ADHD and helps with medication decisions, children and young people will be asked to complete the task as part of their initial assessment for ADHD. Half the participants and their clinician will have access to the QbTest result; the other half will not have access to the QbTest result until the end of the study.
Participant's parents, teachers and the clinician will also be asked to complete some questionnaires about the child's symptoms and behaviour. If the child is diagnosed with ADHD and is given medication they will be asked to complete the task again on medication. The same set of questionnaires will be completed by the parents/teachers/clinicians.
The entire sample will be followed up at 6 months and asked to complete the questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6-17 years (may turn 18 years during the study).
- •Referred to CAMHS or community paediatrics for an ADHD assessment
- •Capable of providing written informed consent (over 16)
- •Parental consent (under 16)
排除标准
- •Non-fluent English
- •Suspected moderate or severe learning disability
- •Previous or current diagnosis of ADHD
结局指标
主要结局
Number of clinic appointments until correct diagnosis confirmed
时间窗: By 6 months
Number of clinic appointments until correct ADHD diagnosis is confirmed or excluded for the QBOpen (delivery of immediate QbTest feedback report) and QbBlind (delayed feedback of QbTest report) groups.
次要结局
- Time to confirmation or exclusion of ADHD diagnosis (in days) and duration of clinic visits (in minutes).(Up to 6 months)