Assessing QbTest Utility in ADHD: A Randomised Controlled Trial

NCT ID: NCT02209116

Last Updated: 2016-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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QB Open

Participants and their clinician will receive results of the Qb Test

Group Type ACTIVE_COMPARATOR

Qb Test

Intervention Type OTHER

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

Qb Blind

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

Group Type OTHER

Qb Test

Intervention Type OTHER

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

Interventions

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Qb Test

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

Intervention Type OTHER

Other Intervention Names

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Qb Test of Activity and Attention

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Hollis, MRC Psych, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham, Nottingham HC Trust

Locations

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Central Manchester University Hospitals NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Site Status

Medway NHS Foundation Trust

Gillingham, Kent, United Kingdom

Site Status

Bridgewater Community Healthcare NHS Trust

Wigan, Lancashire, United Kingdom

Site Status

Leicestershire Partnership Nhs Trust

Leicester, Leicestershire, United Kingdom

Site Status

United Lincolnshire Hospitals NHS Trust

Lincoln, Lincolnshire, United Kingdom

Site Status

Alder Hey Children's NHS Foundation Trust

Liverpool, Merseyside, United Kingdom

Site Status

Nottinghamshire Healthcare Nhs Trust

Nottingham, Nottinghamshire, United Kingdom

Site Status

Nottingham University Hospitals Nhs Trust

Nottingham, Nottinghamshire, United Kingdom

Site Status

Sussex Partnership NHS Foundation Trust

Worthing, Sussex, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 25448628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25948406 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29700813 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28183284 (View on PubMed)

Other Identifiers

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CLAHRC-EM 14046

Identifier Type: -

Identifier Source: org_study_id

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