QbTest Utility for Optimising Treatment in ADHD (QUOTA)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): QbTest
Intervention type(s): Device
Intervention description(s): QbTest is a computerised assessment which takes approximately 20mins. The test combines a continuous performance test alongside an infrared camera which measures the participant's movements. The infrared camera measures motor activity of the participant whilst they undertake the task. During the test, the participant is presented with continuously changing stimuli. Embedded within these stimuli is a given target. Participants have to respond by pressing a hand-held button only when the target appears. Attention is measured through omission errors and reaction time to response. Impulsivity is assessed through commission errors and anticipatory errors. Motor activity is measured through head movements during the task. The test is approved by the FDA (Ref: K133382) and CE marked.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants in the experimental arm (QbTest) protocol will also undergo standard assessment as usual plus a QbTest. If a QbTest was not conducted within 12 weeks prior to starting medication (as part of the ADHD diagnostic assessment procedure) the young person will sit a QbTest at baseline (off medication). Once on medication they will sit another QbTest 2-4 weeks after commencing medication and again 8-10 weeks later (and no later than 12 weeks).
Participants in the control arm will undergo standard treatment as usual for ADHD. This will involve the clinician reviewing the child's symptom improvement once on medication and altering the dose according to their clinical judgement which may be informed by rating scales (completed by the parent, teacher and/or young person) and interviews with the parent and young person.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Cognitive Assessment; QbTest; Medication; Feasibility