Assessing QbTest Utility in ADHD: A Randomised Controlled Trial

NCT02209116 | Completed DMC

• 1 other identifier: CLAHRC-EM 14046
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 9

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time to confirmation or exclusion of ADHD diagnosis (in days) and duration of clinic visits (in minutes).

  Up to 6 months

Other Outcomes (2)

• Degree of Confidence of diagnosis

  Up to 6 months

• Stability in diagnosis and confidence between the QbO and QbB group

  Up to 6 months

Study Arms (2)

QB Open

ACTIVE COMPARATOR

Participants and their clinician will receive results of the Qb Test

Other: Qb Test

Qb Blind

OTHER

Participants and their clinician will be blind to the results of the Qb test

Other: Qb Test

Interventions

Qb Test OTHER

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

Also known as: Qb Test of Activity and Attention

QB Open; Qb Blind

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Nottingham: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (9)

Central Manchester University Hospitals NHS Foundation Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

Medway NHS Foundation Trust

Gillingham, Kent, ME7 5NY, United Kingdom

Location

Bridgewater Community Healthcare NHS Trust

Wigan, Lancashire, WN3 6PR, United Kingdom

Location

Leicestershire Partnership Nhs Trust

Leicester, Leicestershire, LE5 0TD, United Kingdom

Location

United Lincolnshire Hospitals NHS Trust

Lincoln, Lincolnshire, LN2 4AX, United Kingdom

Location

Alder Hey Children's NHS Foundation Trust

Liverpool, Merseyside, L12 2AP, United Kingdom

Location

Nottinghamshire Healthcare Nhs Trust

Nottingham, Nottinghamshire, NG3 6AA, United Kingdom

Location

Nottingham University Hospitals Nhs Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Sussex Partnership NHS Foundation Trust

Worthing, Sussex, BN13 3EP, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 25448628 BACKGROUND

• 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.

  PMID: 25948406 BACKGROUND

• 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.

  PMID: 29700813 DERIVED

• 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.

  PMID: 28183284 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Chris Hollis, MRC Psych, PhD

  University of Nottingham, Nottingham HC Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 5, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 22, 2016

Record last verified: 2016-06

Locations

GB (9)