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

June 19, 2017 updated by: Kaiser Permanente
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Folsom, California, United States, 95630
        • Kaiser Permanente, Folsom
      • Roseville, California, United States, 95661
        • Kaiser Permanente, Roseville
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente, Walnut Creek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • OpTAX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One month, 3 month and six month follow ups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post baseline
Academic Performance
Time Frame: Baseline and Six Months
Academic performance will be measured by student report cards, and converted to a standardized scale
Baseline and Six Months
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
Baseline to Six Months
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
Baseline to six months
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
Six months
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.
Baseline to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

Pearson/Clinical Assessment

Investigators

  • Principal Investigator: Cynthia I Campbell, PhD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 13, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 24, 2014

Study Record Updates

Last Update Posted (Actual)

July 17, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN-13-1692-H
  • Quotient ADHD (Other Identifier: Abbreviated study title)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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