Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of the Quotient® ADHD Assessment in a System of Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02094612
Recruitment Status : Terminated
First Posted : March 24, 2014
Results First Posted : July 17, 2017
Last Update Posted : July 17, 2017
Sponsor:
Collaborator:
Pearson/Clinical Assessment
Information provided by (Responsible Party):
Kaiser Permanente

Tracking Information
First Submitted Date  ICMJE March 13, 2014
First Posted Date  ICMJE March 24, 2014
Results First Submitted Date  ICMJE January 31, 2017
Results First Posted Date  ICMJE July 17, 2017
Last Update Posted Date July 17, 2017
Study Start Date  ICMJE March 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
Number of Participants With 25% Reduction in SNAP Scores [ Time Frame: One month, 3 month and six month follow ups ]
Outcome measure reported is the number of participants with at least one 25% reduction in SNAP between visits. In treatment of ADHD, the therapeutic dose is defined as a 25% reduction in SNAP IV score between consecutive clinic visits. SNAP is itemized rating scale (Swanson, Nolan, and Pelham-IV Questionnaire) designed to measure ADHD symptoms and severity on a 4 point scale. It is based on DSM IV criteria, and is designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults ages 6-18.
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2014)
Time to therapeutic dose [ Time Frame: One month, 3 month and six month follow ups ]
The primary outcome measure will be change in the dose of ADHD medication as measured across three followup time points, comparing a Usual Care group and a Quotient test group. The hypothesis is that patients who receive the Quotient test (the computerized neuroassessment) will reach a stable therapeutic dose of ADHD medication more quickly, compared to Usual Care.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
  • ADHD Symptomatology [ Time Frame: 6 months post baseline ]
    Outcomes reported are average SNAP IV scores at baseline and 6 monhts. ADHD symptomatology is measured by the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), developed by James Swanson, Edith Nolan and William Pelham. We used the 18-item self-report inventory designed to measure attention deficit hyperactivity disorder (ADHD) symptoms in children and young adults. Each question measures the frequency of a variety of symptoms or behaviors.The subscales measure Inattention (9 items) and Hyperactivity/impulsivity (9 items), using 0-3 rating, 0="not at all", 1="just a little", 2="quite a bit", or 3="very much. Each 9-item subscale results in a score in range 0-27. The two subscale scores were averaged to create a single score for the 18-item SNAP.
  • Academic Performance [ Time Frame: Baseline and Six Months ]
    Academic performance will be measured by student report cards, and converted to a standardized scale
  • Persistence in Care [ Time Frame: Baseline to Six Months ]
    Update: Outcome measure reported is the # of participants who attended all study follow-up visits. Use of pediatric health care services
  • Medication Adherence [ Time Frame: Baseline to six months ]
    Update: Outcome reported is number of participants taking medication as prescribed at all study follow up visits. Sustained use of ADHD medication
  • Satisfaction With Care [ Time Frame: Six months ]
    Update: Outcome measure reported is number of participants who responded "very satisfied" with their ADHD care on 5-point Likert scale. Likert scale single item measure of how satisfied the pediatric patient's parent was with care received
  • Other Health Services Use [ Time Frame: Baseline to six months ]
    Update: Outcome measure reported is number of psychiatric and ED visits during the 6 month follow up period. Use of healthcare services outside of pediatrics, including the emergency room and psychiatric services.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2014)
  • ADHD Symtomatology [ Time Frame: 1, 3 and 6 months post baseline ]
    ADHD symptomatology measured by the SNAP-IV
  • Academic Performance [ Time Frame: Baseline and Six Months ]
    Academic performance will be measured by student report cards, and converted to a standardized scale
  • Persistence in Care [ Time Frame: Baseline to Six Months ]
    Use of pediatric health care services
  • Medication Adherence [ Time Frame: Baseline to six months ]
    Sustained use of ADHD medication
  • Satisfaction With Care [ Time Frame: Six months ]
    Likert scale single item measure of how satisfied the pediatric patient's parent was with care received
  • Other Health Services Use [ Time Frame: Baseline to six months ]
    Use of healthcare services outside of pediatrics, including the emergency room and psychiatric services.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of the Quotient® ADHD Assessment in a System of Care
Official Title  ICMJE Effectiveness of the Quotient® ADHD Assessment in a System of Care
Brief Summary The study goal is to examine whether the use of an objective computerized neuroassessment (the Quotient System) for Attention-Deficit/Hyperactivity Disorder (ADHD) is related to improved outcomes among pediatric patients being assessed and treated for ADHD.
Detailed Description This study is a randomized, controlled trial using a 2-phase data collection. The first phase is the initial assessment for ADHD and includes all patients eligible to be assessed for ADHD as determined by their clinician in the course of usual care. The baseline measurements will be used to compare groups at baseline, and also for longitudinal analyses of medication management. Patients are randomized at this point. Patients in both treatment arms who then receive an ADHD diagnosis and who start medication for ADHD will be eligible for the second phase of the study: three follow-up assessments over six months. Patients who do not have an ADHD diagnosis will not continue in the study, and will be treated by their clinician as usual.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Attention Deficit and Disruptive Behavior Disorders
  • Attention Deficit Disorder With Hyperactivity
Intervention  ICMJE
  • Device: Quotient®
    Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers.
    Other Name: OpTAX
  • Behavioral: Usual Clinic ADHD Care
    Usual ADHD care as provided by the clinic
Study Arms  ICMJE
  • Active Comparator: Usual Care
    Usual clinic ADHD care
    Intervention: Behavioral: Usual Clinic ADHD Care
  • Experimental: Usual Care plus Assessment
    Usual clinic ADHD care plus the Quotient®
    Intervention: Device: Quotient®
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 19, 2017)
207
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2014)
500
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients within the specified age range who are English speaking and who are presenting for ADHD assessment are eligible. An additional criterion is consent to be randomized.

Exclusion Criteria:

  • Non English speaking
  • Refusal to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02094612
Other Study ID Numbers  ICMJE CN-13-1692-H
Quotient ADHD ( Other Identifier: Abbreviated study title )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE Pearson/Clinical Assessment
Investigators  ICMJE
Principal Investigator: Cynthia I Campbell, PhD Kaiser Permanente
PRS Account Kaiser Permanente
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP