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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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®
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
- 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.
- 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.
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
|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|
|Principal Investigator:||Cynthia I Campbell, PhD||Kaiser Permanente|