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Assessing QbTest Utility in ADHD: A Randomised Controlled Trial (AQUA2)

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ClinicalTrials.gov Identifier: NCT02209116
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : June 22, 2016
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Nottingham

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.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Other: Qb Test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
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 Start Date : July 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: QB Open
Participants and their clinician will receive results of the Qb Test
Other: Qb Test
Given to all participants but the results will be open or blind depending on arm allocation
Other Name: Qb Test of Activity and Attention

Qb Blind
Participants and their clinician will be blind to the results of the Qb test
Other: Qb Test
Given to all participants but the results will be open or blind depending on arm allocation
Other Name: Qb Test of Activity and Attention




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to confirmation or exclusion of ADHD diagnosis (in days) and duration of clinic visits (in minutes). [ Time Frame: Up to 6 months ]
    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.


Other Outcome Measures:
  1. Degree of Confidence of diagnosis [ Time Frame: Up to 6 months ]
    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).

  2. Stability in diagnosis and confidence between the QbO and QbB group [ Time Frame: Up to 6 months ]
    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.).



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209116


Locations
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United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M13 9WL
Medway NHS Foundation Trust
Gillingham, Kent, United Kingdom, ME7 5NY
Bridgewater Community Healthcare NHS Trust
Wigan, Lancashire, United Kingdom, WN3 6PR
Leicestershire Partnership Nhs Trust
Leicester, Leicestershire, United Kingdom, LE5 0TD
United Lincolnshire Hospitals NHS Trust
Lincoln, Lincolnshire, United Kingdom, LN2 4AX
Alder Hey Children's NHS Foundation Trust
Liverpool, Merseyside, United Kingdom, L12 2AP
Nottinghamshire Healthcare Nhs Trust
Nottingham, Nottinghamshire, United Kingdom, NG3 6AA
Nottingham University Hospitals Nhs Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sussex Partnership NHS Foundation Trust
Worthing, Sussex, United Kingdom, BN13 3EP
Sponsors and Collaborators
University of Nottingham
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Chris Hollis, MRC Psych, PhD University of Nottingham, Nottingham HC Trust
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02209116    
Other Study ID Numbers: CLAHRC-EM 14046
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Keywords provided by University of Nottingham:
ADHD
QB Test
Activity
Attention
Children
Clinical Decision Making
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders