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

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quotient®
Usual Clinic ADHD Care
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Attention Deficit and Disruptive Behavior Disorders focused on measuring Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder with Hyperactivity, Pediatrics, Patient Outcome Assessment

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente, Folsom
  • Kaiser Permanente, Roseville
  • Kaiser Permanente, Walnut Creek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Usual Care plus Assessment

Arm Description

Usual clinic ADHD care

Usual clinic ADHD care plus the Quotient®

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Academic Performance
Academic performance will be measured by student report cards, and converted to a standardized scale
Persistence in Care
Update: Outcome measure reported is the # of participants who attended all study follow-up visits. Use of pediatric health care services
Medication Adherence
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
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
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.

Full Information

First Posted
March 13, 2014
Last Updated
June 19, 2017
Sponsor
Kaiser Permanente
Collaborators
Pearson/Clinical Assessment
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1. Study Identification

Unique Protocol Identification Number
NCT02094612
Brief Title
Effectiveness of the Quotient® ADHD Assessment in a System of Care
Official Title
Effectiveness of the Quotient® ADHD Assessment in a System of Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Pearson/Clinical Assessment

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder With Hyperactivity
Keywords
Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder with Hyperactivity, Pediatrics, Patient Outcome Assessment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual clinic ADHD care
Arm Title
Usual Care plus Assessment
Arm Type
Experimental
Arm Description
Usual clinic ADHD care plus the Quotient®
Intervention Type
Device
Intervention Name(s)
Quotient®
Other Intervention Name(s)
OpTAX
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Clinic ADHD Care
Intervention Description
Usual ADHD care as provided by the clinic
Primary Outcome Measure Information:
Title
Number of Participants With 25% Reduction in SNAP Scores
Description
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.
Time Frame
One month, 3 month and six month follow ups
Secondary Outcome Measure Information:
Title
ADHD Symptomatology
Description
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.
Time Frame
6 months post baseline
Title
Academic Performance
Description
Academic performance will be measured by student report cards, and converted to a standardized scale
Time Frame
Baseline and Six Months
Title
Persistence in Care
Description
Update: Outcome measure reported is the # of participants who attended all study follow-up visits. Use of pediatric health care services
Time Frame
Baseline to Six Months
Title
Medication Adherence
Description
Update: Outcome reported is number of participants taking medication as prescribed at all study follow up visits. Sustained use of ADHD medication
Time Frame
Baseline to six months
Title
Satisfaction With Care
Description
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
Time Frame
Six months
Title
Other Health Services Use
Description
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.
Time Frame
Baseline to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia I Campbell, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente, Folsom
City
Folsom
State/Province
California
ZIP/Postal Code
95630
Country
United States
Facility Name
Kaiser Permanente, Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Kaiser Permanente, Walnut Creek Medical Center
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States

12. IPD Sharing Statement

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

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