QbTest Utility for Optimising Treatment in ADHD (QUOTA)

NCT03368573 | Completed

• 1 other identifier: PB-PG-1215-20026
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD; Cognitive Assessment; QbTest; Medication; Feasibility

Outcome Measures

Primary Outcomes (1)

• SNAP-IV

  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.

  Follow up 2 (8-10 weeks)

Secondary Outcomes (7)

• 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)

• CGI (Clinical Global Impressions Scale)

  Baseline (0 weeks), Follow up 2 (8-10 weeks)

• Health Economic Outcome

  Follow up 2 (8-10 weeks)

• Side Effects Questionnaire

  Follow up 1 (2-4 weeks) and Follow up 2 (8-10 weeks)

Study Arms (2)

Control Arm

NO INTERVENTION

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

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).

Device: QbTest

Interventions

QbTest DEVICE

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.

Experimental Arm

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottinghamshire Healthcare NHS Trust: lead

Study Sites (1)

Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, NG3 6AA, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 33726855 DERIVED

• 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.

  PMID: 31215440 DERIVED

• 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.

  PMID: 29453304 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 11, 2017
• Study Start: December 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: October 31, 2018
• Last Updated: March 3, 2021

Record last verified: 2017-12

Locations

GB (1)