<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02209116</url>
  </required_header>
  <id_info>
    <org_study_id>CLAHRC-EM 14046</org_study_id>
    <nct_id>NCT02209116</nct_id>
  </id_info>
  <brief_title>Assessing QbTest Utility in ADHD: A Randomised Controlled Trial</brief_title>
  <acronym>AQUA2</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Attention Deficit/Hyperactivity Disorder (ADHD)is one of the most common mental health&#xD;
      disorders of childhood. Children with ADHD often have poor attention, are restless and&#xD;
      hyperactive and show impulsive behaviour.&#xD;
&#xD;
      It is important to detect ADHD so young people can have access to appropriate clinical&#xD;
      interventions.&#xD;
&#xD;
      One of the most common ways ADHD is assessed is through the clinician's opinion; however,&#xD;
      this can vary between clinicians and is thought to be one reason why ADHD may be&#xD;
      mis-diagnosed. Using a more objective computer tasks may help improve our understanding of&#xD;
      ADHD. One computer task is the QbTest.&#xD;
&#xD;
      The test presents different symbols to the child, and the child has to respond by pressing a&#xD;
      button only when a target symbol appears. The test measures the child's attention,&#xD;
      impulsivity and movement whilst doing this task.&#xD;
&#xD;
      Although the test is thought to be a valid measure, more research needs to be conducted on&#xD;
      this measure to see whether it helps clinicians decision making.&#xD;
&#xD;
      To see whether this test helps clinicians make a diagnosis of ADHD and helps with medication&#xD;
      decisions, children and young people will be asked to complete the task as part of their&#xD;
      initial assessment for ADHD. Half the participants and their clinician will have access to&#xD;
      the QbTest result; the other half will not have access to the QbTest result until the end of&#xD;
      the study.&#xD;
&#xD;
      Participant's parents, teachers and the clinician will also be asked to complete some&#xD;
      questionnaires about the child's symptoms and behaviour. If the child is diagnosed with ADHD&#xD;
      and is given medication they will be asked to complete the task again on medication. The same&#xD;
      set of questionnaires will be completed by the parents/teachers/clinicians.&#xD;
&#xD;
      The entire sample will be followed up at 6 months and asked to complete the questionnaires.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of clinic appointments until correct diagnosis confirmed</measure>
    <time_frame>By 6 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to confirmation or exclusion of ADHD diagnosis (in days) and duration of clinic visits (in minutes).</measure>
    <time_frame>Up to 6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Degree of Confidence of diagnosis</measure>
    <time_frame>Up to 6 months</time_frame>
    <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).</description>
  </other_outcome>
  <other_outcome>
    <measure>Stability in diagnosis and confidence between the QbO and QbB group</measure>
    <time_frame>Up to 6 months</time_frame>
    <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.).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">267</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder (ADHD)</condition>
  <arm_group>
    <arm_group_label>QB Open</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants and their clinician will receive results of the Qb Test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Qb Blind</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants and their clinician will be blind to the results of the Qb test</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Qb Test</intervention_name>
    <description>Given to all participants but the results will be open or blind depending on arm allocation</description>
    <arm_group_label>QB Open</arm_group_label>
    <arm_group_label>Qb Blind</arm_group_label>
    <other_name>Qb Test of Activity and Attention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 6-17 years (may turn 18 years during the study).&#xD;
&#xD;
          -  Referred to CAMHS or community paediatrics for an ADHD assessment&#xD;
&#xD;
          -  Capable of providing written informed consent (over 16)&#xD;
&#xD;
          -  Parental consent (under 16)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-fluent English&#xD;
&#xD;
          -  Suspected moderate or severe learning disability&#xD;
&#xD;
          -  Previous or current diagnosis of ADHD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris Hollis, MRC Psych, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham, Nottingham HC Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Manchester University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medway NHS Foundation Trust</name>
      <address>
        <city>Gillingham</city>
        <state>Kent</state>
        <zip>ME7 5NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bridgewater Community Healthcare NHS Trust</name>
      <address>
        <city>Wigan</city>
        <state>Lancashire</state>
        <zip>WN3 6PR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicestershire Partnership Nhs Trust</name>
      <address>
        <city>Leicester</city>
        <state>Leicestershire</state>
        <zip>LE5 0TD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Lincolnshire Hospitals NHS Trust</name>
      <address>
        <city>Lincoln</city>
        <state>Lincolnshire</state>
        <zip>LN2 4AX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alder Hey Children's NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L12 2AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottinghamshire Healthcare Nhs Trust</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG3 6AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals Nhs Trust</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sussex Partnership NHS Foundation Trust</name>
      <address>
        <city>Worthing</city>
        <state>Sussex</state>
        <zip>BN13 3EP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.clahrc-em.nihr.ac.uk/clahrc-em-nihr/research/enhancing-mental-health/aqua-trial.aspx</url>
    <description>Click here to go to CLAHRC EM website - AQUA study</description>
  </link>
  <reference>
    <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.</citation>
    <PMID>25448628</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25948406</PMID>
  </reference>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>June 21, 2016</last_update_submitted>
  <last_update_submitted_qc>June 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD</keyword>
  <keyword>QB Test</keyword>
  <keyword>Activity</keyword>
  <keyword>Attention</keyword>
  <keyword>Children</keyword>
  <keyword>Clinical Decision Making</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>February 5, 2019</submitted>
    <returned>May 3, 2019</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02209116
org study id: CLAHRC-EM 14046
nct id: NCT02209116
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Number of clinic appointments until correct diagnosis confirmed
time frame: By 6 months
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.
measure: Time to confirmation or exclusion of ADHD diagnosis (in days) and duration of clinic visits (in minutes).
time frame: Up to 6 months
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.
measure: Degree of Confidence of diagnosis
time frame: Up to 6 months
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).
measure: Stability in diagnosis and confidence between the QbO and QbB group
time frame: Up to 6 months
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.).
arm group label: QB Open
arm group type: Active Comparator
description: Participants and their clinician will receive results of the Qb Test
arm group label: Qb Blind
arm group type: Other
description: Participants and their clinician will be blind to the results of the Qb test
intervention type: Other
intervention name: Qb Test
description: Given to all participants but the results will be open or blind depending on arm allocation
arm group label: QB Open
arm group label: Qb Blind
other name: Qb Test of Activity and Attention
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Chris Hollis, MRC Psych, PhD
role: Principal Investigator
affiliation: University of Nottingham, Nottingham HC Trust
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
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
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.
PMID: 25448628
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.
PMID: 25948406
responsible party type: Sponsor
mesh term: Attention Deficit Disorder with Hyperactivity
submitted: February 5, 2019
returned: May 3, 2019