QbTest Utility for Optimising Treatment in ADHD (QUOTA)

Nottinghamshire Healthcare NHS Trust

Status: Completed

Conditions: ADHD

Treatments: Device: QbTest

Study type: Interventional

Funder types: Other

Identifiers

NCT03368573

PB-PG-1215-20026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

43 participants in 2 patient groups

Control Arm

No Intervention group

Description:

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.

Experimental Arm

Experimental group

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).

Treatment:

Device: QbTest