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Assessing QbTest Utility in ADHD: A Randomised Controlled Trial

A RCT Comparing the Effects of Providing Clinicians and Patients With the Results of an Objective Measure of Activity and Attention (QbTest) Versus Usual Care on Diagnostic and Treatment Decision Making in Children and Young People With ADHD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02209116
Acronym
AQUA2
Enrollment
267
Registered
2014-08-05
Start date
2014-07-31
Completion date
2016-06-30
Last updated
2016-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

ADHD, QB Test, Activity, Attention, Children, Clinical Decision Making

Brief summary

Attention Deficit/Hyperactivity Disorder (ADHD)is one of the most common mental health disorders of childhood. Children with ADHD often have poor attention, are restless and hyperactive and show impulsive behaviour. It is important to detect ADHD so young people can have access to appropriate clinical interventions. One of the most common ways ADHD is assessed is through the clinician's opinion; however, this can vary between clinicians and is thought to be one reason why ADHD may be mis-diagnosed. Using a more objective computer tasks may help improve our understanding of ADHD. One computer task is the QbTest. The test presents different symbols to the child, and the child has to respond by pressing a button only when a target symbol appears. The test measures the child's attention, impulsivity and movement whilst doing this task. Although the test is thought to be a valid measure, more research needs to be conducted on this measure to see whether it helps clinicians decision making. To see whether this test helps clinicians make a diagnosis of ADHD and helps with medication decisions, children and young people will be asked to complete the task as part of their initial assessment for ADHD. Half the participants and their clinician will have access to the QbTest result; the other half will not have access to the QbTest result until the end of the study. Participant's parents, teachers and the clinician will also be asked to complete some questionnaires about the child's symptoms and behaviour. If the child is diagnosed with ADHD and is given medication they will be asked to complete the task again on medication. The same set of questionnaires will be completed by the parents/teachers/clinicians. The entire sample will be followed up at 6 months and asked to complete the questionnaires.

Interventions

OTHERQb Test

Given to all participants but the results will be open or blind depending on arm allocation

Sponsors

National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
University of Nottingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Age 6-17 years (may turn 18 years during the study). * Referred to CAMHS or community paediatrics for an ADHD assessment * Capable of providing written informed consent (over 16) * Parental consent (under 16)

Exclusion criteria

* Non-fluent English * Suspected moderate or severe learning disability * Previous or current diagnosis of ADHD

Design outcomes

Primary

MeasureTime frameDescription
Number of clinic appointments until correct diagnosis confirmedBy 6 monthsNumber of clinic appointments until correct ADHD diagnosis is confirmed or excluded for the QBOpen (delivery of immediate QbTest feedback report) and QbBlind (delayed feedback of QbTest report) groups.

Secondary

MeasureTime frameDescription
Time to confirmation or exclusion of ADHD diagnosis (in days) and duration of clinic visits (in minutes).Up to 6 monthsTime to confirmation or exclusion of ADHD diagnosis (in days) and duration of clinic visits (in minutes). This will provide supporting evidence that a reduced number of clinic visits is associated with shorter overall time to diagnosis and reduced clinic time required for assessment.

Other

MeasureTime frameDescription
Degree of Confidence of diagnosisUp to 6 monthsDifferences in degree of confidence of diagnosis between cases in QbOpen (QbO) and QbBlind (QbB) group. These variables will assess the utility of QbTest in aiding diagnosis (diagnostic certainty).
Stability in diagnosis and confidence between the QbO and QbB groupUp to 6 monthsStability in diagnosis and confidence between the QbO and QbB group measured as number of patients where the primary diagnosis (ADHD confirmed or excluded) was changed at their 6 month visit to the clinic.).

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026