Assessing QbTest Utility in ADHD: A Randomised Controlled Trial

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

— AQUA2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209116
• Other study ID #: CLAHRC-EM 14046
• Status: Completed
• Phase: N/A
• First received: August 4, 2014
• Last updated: June 21, 2016
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)

Intervention

Other:
• Qb Test
Given to all participants but the results will be open or blind depending on arm allocation

Locations

Country	Name	City	State
United Kingdom	Medway NHS Foundation Trust	Gillingham	Kent
United Kingdom	Leicestershire Partnership Nhs Trust	Leicester	Leicestershire
United Kingdom	United Lincolnshire Hospitals NHS Trust	Lincoln	Lincolnshire
United Kingdom	Alder Hey Children's NHS Foundation Trust	Liverpool	Merseyside
United Kingdom	Central Manchester University Hospitals NHS Foundation Trust	Manchester	Greater Manchester
United Kingdom	Nottingham University Hospitals Nhs Trust	Nottingham	Nottinghamshire
United Kingdom	Nottinghamshire Healthcare Nhs Trust	Nottingham	Nottinghamshire
United Kingdom	Bridgewater Community Healthcare NHS Trust	Wigan	Lancashire
United Kingdom	Sussex Partnership NHS Foundation Trust	Worthing	Sussex

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. Erratum in: BMJ Open. 2015;5(5):e006838corr1. BMJ Open. 2016;6(1):e006838corr2. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Degree of Confidence of diagnosis	Differences 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).	Up to 6 months	No
Other	Stability in diagnosis and confidence between the QbO and QbB group	Stability 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.).	Up to 6 months	No
Primary	Number of clinic appointments until correct diagnosis confirmed	Number 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.	By 6 months	No
Secondary	Time to confirmation or exclusion of ADHD diagnosis (in days) and duration of clinic visits (in minutes).	Time 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.	Up to 6 months	No

External Links

•   Click here to go to CLAHRC EM website - AQUA study