Optimising Medication Management in Children and Young People With Attention Deficit Hyperactivity Disorder (ADHD) Using an Objective Measure of Attention, Impulsivity and Activity (QbTest): a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- SNAP-IV
研究概览
简要总结
Attention Deficit/Hyperactivity Disorder (ADHD) is a condition that affects 3-5% of young people under 18-years-old.
Young people with ADHD have difficulties with attention, impulsivity and hyperactivity that make it harder for them to learn, form relationships and prepare for adulthood. Clinical guidelines state that young people taking medication for ADHD should be closely monitored and have their medication reviewed regularly to ensure they receive the correct dose to improve their symptoms. However, many young people aren't monitored as closely as guidelines recommend. This can lead to lack of improvement or worsening of symptoms meaning that children may not experience the benefits of medication as quickly as they should. At the moment, assessing whether or not medication is working relies on the opinions of teachers and parents, collected through questionnaires. The difficulties of this are: differences of opinion between people, lack of information provided by them, and not returning the questionnaires. A test performed on a computer (QbTest) provides doctors with a report of the young person's symptoms and can therefore show whether medication is working. This may help doctors reach accurate decisions about medication dose more quickly, reducing the need for questionnaires. The study team met with families and young people with ADHD and medical experts and developed a procedure for using QbTest to measure medication effects. The study team will measure how well this procedure works in the real world by asking a group of young people to complete the test when they first start taking medication and at their follow-up appointments. The study team will ask doctors and families/young people for their opinions on the procedure.
The study team shall share our findings with other researchers and with the public by attending local support groups and providing summaries of the study results. The findings will be used to prepare for a future study.
详细描述
The primary objective of the study is to assess the feasibility and acceptability of the study design using a feasibility RCT.
The end-points to assess this objective are:
- Acceptability of randomisation. The number of patients who do not participate and state randomisation as the reason for non-participation. The study team shall also monitor drop-out rates immediately after randomisation and the number of errors in randomisation at each site.
- Acceptability of study design. The number of eligible patients at each site and the numbers who consent to take part/withdraw. Withdrawal rates will be recorded alongside time point in the trial to ascertain acceptability of the study duration.
- Acceptability of outcome measures. Completion rates for outcomes to determine most appropriate methods of data collection.
- Acceptability/feasibility of protocol. Record non-adherence of healthcare professionals to the protocol and explore reasons.
- Feasibility of future RCT. Estimate the hours per week needed to run the RCT and therefore the number of research assistants/fellows required and time commitment required by HCPs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or Female, aged 6-17 years (at the time of consent).
- •Participant is willing and able to give informed consent for participation in the study (if over 16-years).
- •Parental consent for children and young people aged under 16-years-old.
- •Referred to CAMHS or Community Pediatric services and diagnosed with ADHD.
- •Clinician and family (parent/carer and young person/child) agreement to commence stimulant medication for ADHD symptoms.
排除标准
- •Unable to give informed consent
- •Severe learning difficulty
- •Not started on stimulant medication (either not started on medication at all or started on a non-stimulant medication)
- •Non-fluent English
结局指标
主要结局
SNAP-IV
时间窗: Follow up 2 (8-10 weeks)
SNAP-IV is a short questionnaire designed to assess ADHD symptoms, with established validity, reliability and use in clinical and research settings. Completed by Parents and Teachers.
次要结局
- CGI (Clinical Global Impressions Scale)(Baseline (0 weeks), Follow up 2 (8-10 weeks))
- Health Economic Outcome(Follow up 2 (8-10 weeks))
- Medication adherence(Follow up 1 (2-4 weeks) and Follow up 2 (8-10 weeks))
- Side Effects Questionnaire(Follow up 1 (2-4 weeks) and Follow up 2 (8-10 weeks))
- Qualitative Interviews(Follow up 2 (8-10 weeks))
- SDQ(Baseline (0 weeks), Follow up 2 (8-10 weeks))
- CHU9D(Baseline (0 weeks), Follow up 1 (2-4 weeks), Follow up 2 (8-10 weeks))