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

Not Applicable

Terminated

• Conditions: Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder With Hyperactivity
• Interventions: Behavioral: Usual Clinic ADHD Care; Device: Quotient®

• Registration Number: NCT02094612
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-24
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2017-01-31
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-19
• Last Update Submitted: 2017-06-19
• Results First Posted: 2017-07-17
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Clinic ADHD Care	Usual clinic ADHD care
Usual Care plus Assessment	Quotient®	Usual clinic ADHD care plus the Quotient®

Primary Outcome Measures

Name	Time	Method
Number of Participants With 25% Reduction in SNAP Scores	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

Name	Time	Method
Satisfaction With Care	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	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.
ADHD Symptomatology	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	Baseline and Six Months	Academic performance will be measured by student report cards, and converted to a standardized scale
Persistence in Care	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	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

Trial Locations

Locations (3)

Kaiser Permanente, Folsom; 🇺🇸 Folsom, California, United States

Kaiser Permanente, Roseville; 🇺🇸 Roseville, California, United States

Kaiser Permanente, Walnut Creek Medical Center; 🇺🇸 Walnut Creek, California, United States