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

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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

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.

Condition or disease Intervention/treatment Phase
Attention Deficit and Disruptive Behavior Disorders Attention Deficit Disorder With Hyperactivity Device: Quotient® Behavioral: Usual Clinic ADHD Care Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effectiveness of the Quotient® ADHD Assessment in a System of Care
Study Start Date : March 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Usual Care
Usual clinic ADHD care
Behavioral: Usual Clinic ADHD Care
Usual ADHD care as provided by the clinic

Experimental: Usual Care plus Assessment
Usual clinic ADHD care plus the Quotient®
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Academic Performance [ Time Frame: Baseline and Six Months ]
    Academic performance will be measured by student report cards, and converted to a standardized scale

  3. 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


  4. 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


  5. 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


  6. 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.




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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02094612


Locations
United States, California
Kaiser Permanente, Folsom
Folsom, California, United States, 95630
Kaiser Permanente, Roseville
Roseville, California, United States, 95661
Kaiser Permanente, Walnut Creek Medical Center
Walnut Creek, California, United States, 94596
Sponsors and Collaborators
Kaiser Permanente
Pearson/Clinical Assessment
Investigators
Principal Investigator: Cynthia I Campbell, PhD Kaiser Permanente

Publications:

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02094612     History of Changes
Other Study ID Numbers: CN-13-1692-H
Quotient ADHD ( Other Identifier: Abbreviated study title )
First Posted: March 24, 2014    Key Record Dates
Results First Posted: July 17, 2017
Last Update Posted: July 17, 2017
Last Verified: June 2017

Keywords provided by Kaiser Permanente:
Attention Deficit and Disruptive Behavior Disorders
Attention Deficit Disorder with Hyperactivity
Pediatrics
Patient Outcome Assessment

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Neurodevelopmental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms