Clinical trial NCT03368573: QbTest Utility for Optimising Treatment in ADHD (QUOTA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
Cognitive Assessment
QbTest
Medication
Feasibility
Lead sponsor: Nottinghamshire Healthcare NHS Trust
Sponsor class: OTHER_GOV
First posted: 2017-12-11
Enrollment: 43
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: SNAP-IV
timeFrame: Follow up 2 (8-10 weeks)
Secondary outcomes:
measure: SDQ
timeFrame: Baseline (0 weeks), Follow up 2 (8-10 weeks)
measure: CHU9D
timeFrame: Baseline (0 weeks), Follow up 1 (2-4 weeks), Follow up 2 (8-10 weeks)
measure: CGI (Clinical Global Impressions Scale)
timeFrame: Baseline (0 weeks), Follow up 2 (8-10 weeks)
measure: Health Economic Outcome
timeFrame: Follow up 2 (8-10 weeks)
measure: Side Effects Questionnaire
timeFrame: Follow up 1 (2-4 weeks) and Follow up 2 (8-10 weeks)
measure: Medication adherence
timeFrame: Follow up 1 (2-4 weeks) and Follow up 2 (8-10 weeks)
measure: Qualitative Interviews
timeFrame: Follow up 2 (8-10 weeks)
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottinghamshire Healthcare NHS Foundation Trust
Study officials:
References:
citation: Williams L, Hall CL, Brown S, Guo B, James M, Franceschini M, Clarke J, Selby K, Vijayan H, Kulkarni N, Brown N, Sayal K, Hollis C, Groom MJ. Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial. Pilot Feasibility Stud. 2021 Mar 16;7(1):68. doi: 10.1186/s40814-021-00788-1.
citation: Hall CL, Brown S, James M, Martin JL, Brown N, Selby K, Clarke J, Williams L, Sayal K, Hollis C, Groom MJ. Consensus workshops on the development of an ADHD medication management protocol using QbTest: developing a clinical trial protocol with multidisciplinary stakeholders. BMC Med Res Methodol. 2019 Jun 18;19(1):126. doi: 10.1186/s12874-019-0772-2.
citation: Hall CL, James M, Brown S, Martin JL, Brown N, Selby K, Clarke J, Vijayan H, Guo B, Sayal K, Hollis C, Groom MJ. Protocol investigating the clinical utility of an objective measure of attention, impulsivity and activity (QbTest) for optimising medication management in children and young people with ADHD 'QbTest Utility for Optimising Treatment in ADHD' (QUOTA): a feasibility randomised controlled trial. BMJ Open. 2018 Feb 15;8(2):e021104. doi: 10.1136/bmjopen-2017-021104.