Clinical trial NCT02209116: Assessing QbTest Utility in ADHD: A Randomised Controlled Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: ADHD
QB Test
Activity
Attention
Children
Clinical Decision Making
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2014-08-05
Enrollment: 267
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of clinic appointments until correct diagnosis confirmed
timeFrame: By 6 months
Secondary outcomes:
measure: Time to confirmation or exclusion of ADHD diagnosis (in days) and duration of clinic visits (in minutes).
timeFrame: Up to 6 months
Other outcomes:
measure: Degree of Confidence of diagnosis
timeFrame: Up to 6 months
measure: Stability in diagnosis and confidence between the QbO and QbB group
timeFrame: Up to 6 months
Locations:
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust
state: Greater Manchester
city: Gillingham
country: United Kingdom
facility: Medway NHS Foundation Trust
state: Kent
city: Wigan
country: United Kingdom
facility: Bridgewater Community Healthcare NHS Trust
state: Lancashire
city: Leicester
country: United Kingdom
facility: Leicestershire Partnership Nhs Trust
state: Leicestershire
city: Lincoln
country: United Kingdom
facility: United Lincolnshire Hospitals NHS Trust
state: Lincolnshire
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS Foundation Trust
state: Merseyside
city: Nottingham
country: United Kingdom
facility: Nottinghamshire Healthcare Nhs Trust
state: Nottinghamshire
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals Nhs Trust
state: Nottinghamshire
city: Worthing
country: United Kingdom
facility: Sussex Partnership NHS Foundation Trust
state: Sussex
Study officials:
affiliation: University of Nottingham, Nottingham HC Trust
name: Chris Hollis, MRC Psych, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall CL, Walker GM, Valentine AZ, Guo B, Kaylor-Hughes C, James M, Daley D, Sayal K, Hollis C. Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD-'Assessing QbTest Utility in ADHD' (AQUA): a randomised controlled trial. BMJ Open. 2014 Dec 1;4(12):e006838. doi: 10.1136/bmjopen-2014-006838.
citation: Hall CL, Walker GM, Valentine AZ. Correction. Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD - 'Assessing QbTest Utility in ADHD' (AQUA): a randomised controlled trial. BMJ Open. 2015 May 6;5(5):e006838corr1. doi: 10.1136/bmjopen-2014-006838corr1. No abstract available.
citation: Hollis C, Hall CL, Guo B, James M, Boadu J, Groom MJ, Brown N, Kaylor-Hughes C, Moldavsky M, Valentine AZ, Walker GM, Daley D, Sayal K, Morriss R; the AQUA Trial Group. The impact of a computerised test of attention and activity (QbTest) on diagnostic decision-making in children and young people with suspected attention deficit hyperactivity disorder: single-blind randomised controlled trial. J Child Psychol Psychiatry. 2018 Dec;59(12):1298-1308. doi: 10.1111/jcpp.12921. Epub 2018 Apr 26.
citation: Hall CL, Valentine AZ, Walker GM, Ball HM, Cogger H, Daley D, Groom MJ, Sayal K, Hollis C. Study of user experience of an objective test (QbTest) to aid ADHD assessment and medication management: a multi-methods approach. BMC Psychiatry. 2017 Feb 10;17(1):66. doi: 10.1186/s12888-017-1222-5.