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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
Sponsor:
Collaborator:
Pearson/Clinical Assessment
Information provided by (Responsible Party):
Kaiser Permanente

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Attention Deficit and Disruptive Behavior Disorders
Attention Deficit Disorder With Hyperactivity
Interventions Device: Quotient®
Behavioral: Usual Clinic ADHD Care
Enrollment 207
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Usual Care Usual Care Plus Assessment
Hide Arm/Group Description

Usual clinic ADHD care

Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic

Usual clinic ADHD care plus the Quotient®

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.

Period Title: Overall Study
Started 112 95
1 Month Follow up 67 50
3 Month Follow up 50 43
6 Month Follow up 33 25
Completed 33 25
Not Completed 79 70
Reason Not Completed
Lost to Follow-up             47             47
Never started ADHD medication             32             23
Arm/Group Title Usual Care Usual Care Plus Assessment Total
Hide Arm/Group Description

Usual clinic ADHD care

Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic

Usual clinic ADHD care plus the Quotient®

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.

Total of all reporting groups
Overall Number of Baseline Participants 112 95 207
Hide Baseline Analysis Population Description
The population under study consists of children under age 18 who presented at 4 clinics in Northern California Kaiser Permanente for ADHD assessment. The study baseline population consists of 207 potentially eligible participants who enrolled and signed consent for the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 95 participants 207 participants
<=18 years
112
 100.0%
95
 100.0%
207
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 95 participants 207 participants
8.5  (1.9) 8.5  (1.9) 8.5  (1.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 95 participants 207 participants
Female
30
  26.8%
27
  28.4%
57
  27.5%
Male
82
  73.2%
68
  71.6%
150
  72.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 112 participants 95 participants 207 participants
112
 100.0%
95
 100.0%
207
 100.0%
1.Primary Outcome
Title Number of Participants With 25% Reduction in SNAP Scores
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Fifty eight (58) participants completed the study (i.e., had their 6 month follow up appointment) when the study was terminated.
Arm/Group Title Usual Care Usual Care Plus Assessment
Hide Arm/Group Description:

Usual clinic ADHD care

Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic

Usual clinic ADHD care plus the Quotient®

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.

Overall Number of Participants Analyzed 33 25
Measure Type: Count of Participants
Unit of Measure: Participants
29
  87.9%
23
  92.0%
2.Secondary Outcome
Title ADHD Symptomatology
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Usual Care Plus Assessment
Hide Arm/Group Description:

Usual clinic ADHD care

Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic

Usual clinic ADHD care plus the Quotient®

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.

Overall Number of Participants Analyzed 33 25
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Average SNAP score at baseline 17.4  (4.8) 15.0  (4.4)
Average SNAP score at 6 months 9.0  (5.6) 8.6  (5.9)
3.Secondary Outcome
Title Academic Performance
Hide Description Academic performance will be measured by student report cards, and converted to a standardized scale
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
Academic performance was not measured, as there were a very low number of report cards collected (11 of 25 in Quotient arm and 16 of 33 in UC arm).
Arm/Group Title Usual Care Usual Care Plus Assessment
Hide Arm/Group Description:

Usual clinic ADHD care

Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic

Usual clinic ADHD care plus the Quotient®

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Persistence in Care
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Usual Care Plus Assessment
Hide Arm/Group Description:

Usual clinic ADHD care

Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic

Usual clinic ADHD care plus the Quotient®

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.

Overall Number of Participants Analyzed 33 25
Measure Type: Count of Participants
Unit of Measure: Participants
30
  90.9%
25
 100.0%
5.Secondary Outcome
Title Medication Adherence
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Usual Care Plus Assessment
Hide Arm/Group Description:

Usual clinic ADHD care

Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic

Usual clinic ADHD care plus the Quotient®

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.

Overall Number of Participants Analyzed 33 25
Measure Type: Count of Participants
Unit of Measure: Participants
18
  54.5%
17
  68.0%
6.Secondary Outcome
Title Satisfaction With Care
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Usual Care Plus Assessment
Hide Arm/Group Description:

Usual clinic ADHD care

Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic

Usual clinic ADHD care plus the Quotient®

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.

Overall Number of Participants Analyzed 33 25
Measure Type: Count of Participants
Unit of Measure: Participants
28
  84.8%
20
  80.0%
7.Secondary Outcome
Title Other Health Services Use
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Usual Care Plus Assessment
Hide Arm/Group Description:

Usual clinic ADHD care

Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic

Usual clinic ADHD care plus the Quotient®

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.

Overall Number of Participants Analyzed 33 25
Measure Type: Number
Unit of Measure: visits
Number of psych visits 26 22
Number of ED visits 4 2
Time Frame 6 months (from baseline to 6 month follow up)
Adverse Event Reporting Description Adverse events were assessed via periodic chart reviews of study participants..
 
Arm/Group Title Usual Care Usual Care Plus Assessment
Hide Arm/Group Description

Usual clinic ADHD care

Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic

Usual clinic ADHD care plus the Quotient®

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.

All-Cause Mortality
Usual Care Usual Care Plus Assessment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/112 (0.00%)      0/95 (0.00%)    
Hide Serious Adverse Events
Usual Care Usual Care Plus Assessment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/112 (0.89%)      0/95 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
Ashthma  [1]  1/112 (0.89%)  1 0/95 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Through chart review, it was discovered one patient was hospitalized due to severe asthma attack. Child has history of asthma, and this episode was likely triggered by URI. Was deemed by DSMB to not be related to the study.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Usual Care Usual Care Plus Assessment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/112 (0.00%)      0/112 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Monique Does, Project manager
Organization: Kaiser Permanente Division of Research
Phone: 510-891-3612
EMail: monique.does@kp.org
Publications:
Layout table for additonal information
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02094612    
Other Study ID Numbers: CN-13-1692-H
Quotient ADHD ( Other Identifier: Abbreviated study title )
First Submitted: March 13, 2014
First Posted: March 24, 2014
Results First Submitted: January 31, 2017
Results First Posted: July 17, 2017
Last Update Posted: July 17, 2017