Attention Deficit Hyperactivity Disorder (ADHD)AQUA2NCT02209116
Assessing QbTest Utility in ADHD: A Randomised Controlled Trial
A study testing Qb Test in people with Attention Deficit Hyperactivity Disorder (ADHD), run by University of Nottingham at 9 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Qb Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- Jul 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Non-fluent English
- Suspected moderate or severe learning disability
- Previous or current diagnosis of ADHD
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Medway NHS Foundation Trust
Gillingham, Kent, ME7 5NY
Leicestershire Partnership Nhs Trust
Leicester, Leicestershire, LE5 0TD
United Lincolnshire Hospitals NHS Trust
Lincoln, Lincolnshire, LN2 4AX
Alder Hey Children's NHS Foundation Trust
Liverpool, Merseyside, L12 2AP
Central Manchester University Hospitals NHS Foundation Trust
Manchester, Greater Manchester, M13 9WL
Nottinghamshire Healthcare Nhs Trust
Nottingham, Nottinghamshire, NG3 6AA
Nottingham University Hospitals Nhs Trust
Nottingham, Nottinghamshire, NG7 2UH
Bridgewater Community Healthcare NHS Trust
Wigan, Lancashire, WN3 6PR
Sussex Partnership NHS Foundation Trust
Worthing, Sussex, BN13 3EP
About this study
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
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.
Read more
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.
- Being tested
- Qb Test
- Keywords
- ADHD, QB Test, Activity, Attention, Children, Clinical Decision Making
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qb TestOther
Also called Qb Test of Activity and Attention
Given to all participants but the results will be open or blind depending on arm allocation
| Study group | Role | What they receive |
|---|---|---|
| QB Open | Active comparator | Participants and their clinician will receive results of the Qb Test Receives: Other: Qb Test |
| Qb Blind | Other | Participants and their clinician will be blind to the results of the Qb test Receives: Other: Qb Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: By 6 months
Secondary outcomes (1)
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Chris Hollis, MRC Psych, PhD, Principal investigator, University of Nottingham, Nottingham HC Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209116
- Sponsor's protocol ID
- CLAHRC-EM 14046
- Acronym
- AQUA2
- Status last verified
- Jun 2016
- First submitted
- 4 Aug 2014
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25448628Hall 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.
PubMed 25948406Hollis 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.
PubMed 29700813Hall 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.
PubMed 28183284
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02209116
- Acronym / sponsor ID
- AQUA2 / CLAHRC-EM 14046
- Keywords
- ADHD, QB Test, Activity, Attention, Children, Clinical Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Jul 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QB Open | Active comparator | Other: Qb TestParticipants and their clinician will receive results of the Qb Test |
| Qb Blind | Other | Other: Qb TestParticipants and their clinician will be blind to the results of the Qb test |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Non-fluent English
- Suspected moderate or severe learning disability
- Previous or current diagnosis of ADHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qb TestAlso: Qb Test of Activity and AttentionGiven to all participants but the results will be open or blind depending on arm allocation | Other | QB Open, Qb Blind |
Primary outcome
Number of clinic appointments until correct diagnosis confirmed
Time frame: By 6 months
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.
1 secondary outcome
Time to confirmation or exclusion of ADHD diagnosis (in days) and duration of clinic visits (in minutes).
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Background: PubMed 25448628Hall 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.
- Background: PubMed 25948406Hall 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.
- Derived from this study: PubMed 29700813Hollis 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.
- Derived from this study: PubMed 28183284Hall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Hollis, MRC Psych, PhD principal investigator
University of Nottingham, Nottingham HC Trust
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qb Test in people with Attention Deficit Hyperactivity Disorder (ADHD), run by University of Nottingham at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clinic appointments until correct diagnosis confirmed (time frame: By 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02209116, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.