Assessing QbTest Utility in ADHD: A Randomised Controlled Trial

Study Overview
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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.

Official Title
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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

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Other: Qb Test


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: QB Open<br>Participants and their clinician will receive results of the Qb Test | Other: Qb Test<br>* Given to all participants but the results will be open or blind depending on arm allocation<br>* Other names: Qb Test of Activity and Attention;|
| Other: Qb Blind<br>Participants and their clinician will be blind to the results of the Qb test | Other: Qb Test<br>* Given to all participants but the results will be open or blind depending on arm allocation<br>* Other names: Qb Test of Activity and Attention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, QB Test, Activity, Attention, Children, Clinical Decision Making