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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Device: Quotient®
* Behavioral: Usual Clinic ADHD Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Usual clinic ADHD care | Behavioral: Usual Clinic ADHD Care<br>* Usual ADHD care as provided by the clinic<br>|
| Experimental: Usual Care plus Assessment<br>Usual clinic ADHD care plus the Quotient® | Device: Quotient®<br>* 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.<br>* Other names: OpTAX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With 25% Reduction in SNAP Scores | 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. | One month, 3 month and six month follow ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD Symptomatology | 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. | 6 months post baseline | 
| Academic Performance | Academic performance will be measured by student report cards, and converted to a standardized scale | Baseline and Six Months | 
| Persistence in Care | Update: Outcome measure reported is the # of participants who attended all study follow-up visits. Use of pediatric health care services | Baseline to Six Months | 
| Medication Adherence | Update: Outcome reported is number of participants taking medication as prescribed at all study follow up visits. Sustained use of ADHD medication | Baseline to six months | 
| Satisfaction With Care | 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 | Six months | 
| Other Health Services Use | 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. | Baseline to six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder with Hyperactivity, Pediatrics, Patient Outcome Assessment