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

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Qb Test
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring ADHD, QB Test, Activity, Attention, Children, Clinical Decision Making

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Manchester University Hospitals NHS Foundation Trust
  • Medway NHS Foundation Trust
  • Bridgewater Community Healthcare NHS Trust
  • Leicestershire Partnership Nhs Trust
  • United Lincolnshire Hospitals NHS Trust
  • Alder Hey Children's NHS Foundation Trust
  • Nottinghamshire Healthcare Nhs Trust
  • Nottingham University Hospitals Nhs Trust
  • Sussex Partnership NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

QB Open

Qb Blind

Arm Description

Participants and their clinician will receive results of the Qb Test

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 4, 2014
Last Updated
June 21, 2016
Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02209116
Brief Title
Assessing QbTest Utility in ADHD: A Randomised Controlled Trial
Acronym
AQUA2
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 Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD)
Keywords
ADHD, QB Test, Activity, Attention, Children, Clinical Decision Making

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QB Open
Arm Type
Active Comparator
Arm Description
Participants and their clinician will receive results of the Qb Test
Arm Title
Qb Blind
Arm Type
Other
Arm Description
Participants and their clinician will be blind to the results of the Qb test
Intervention Type
Other
Intervention Name(s)
Qb Test
Other Intervention Name(s)
Qb Test of Activity and Attention
Intervention Description
Given to all participants but the results will be open or blind depending on arm allocation
Primary Outcome Measure Information:
Title
Number of clinic appointments until correct diagnosis confirmed
Description
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.
Time Frame
By 6 months
Secondary Outcome Measure Information:
Title
Time to confirmation or exclusion of ADHD diagnosis (in days) and duration of clinic visits (in minutes).
Description
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.
Time Frame
Up to 6 months
Other Pre-specified Outcome Measures:
Title
Degree of Confidence of diagnosis
Description
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).
Time Frame
Up to 6 months
Title
Stability in diagnosis and confidence between the QbO and QbB group
Description
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.).
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Hollis, MRC Psych, PhD
Organizational Affiliation
University of Nottingham, Nottingham HC Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Manchester University Hospitals NHS Foundation Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Medway NHS Foundation Trust
City
Gillingham
State/Province
Kent
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Facility Name
Bridgewater Community Healthcare NHS Trust
City
Wigan
State/Province
Lancashire
ZIP/Postal Code
WN3 6PR
Country
United Kingdom
Facility Name
Leicestershire Partnership Nhs Trust
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE5 0TD
Country
United Kingdom
Facility Name
United Lincolnshire Hospitals NHS Trust
City
Lincoln
State/Province
Lincolnshire
ZIP/Postal Code
LN2 4AX
Country
United Kingdom
Facility Name
Alder Hey Children's NHS Foundation Trust
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Nottinghamshire Healthcare Nhs Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG3 6AA
Country
United Kingdom
Facility Name
Nottingham University Hospitals Nhs Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Sussex Partnership NHS Foundation Trust
City
Worthing
State/Province
Sussex
ZIP/Postal Code
BN13 3EP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25448628
Citation
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. Erratum In: BMJ Open. 2015;5(5):e006838corr1. BMJ Open. 2016;6(1):e006838corr2.
Results Reference
background
PubMed Identifier
25948406
Citation
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.
Results Reference
background
PubMed Identifier
29700813
Citation
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.
Results Reference
derived
PubMed Identifier
28183284
Citation
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.
Results Reference
derived
Links:
URL
http://www.clahrc-em.nihr.ac.uk/clahrc-em-nihr/research/enhancing-mental-health/aqua-trial.aspx
Description
Click here to go to CLAHRC EM website - AQUA study

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Assessing QbTest Utility in ADHD: A Randomised Controlled Trial

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