Attention Deficit and Disruptive Behavior DisordersNCT02094612
Effectiveness of the Quotient® ADHD Assessment in a System of Care
A study testing Quotient® and Usual Clinic ADHD Care in people with Attention Deficit and Disruptive Behavior Disorders and Attention Deficit Disorder With Hyperactivity, run by Kaiser Permanente at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Quotient® and Usual Clinic ADHD Care
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Non English speaking
- Refusal to participate
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kaiser Permanente, Folsom
Folsom, California, 95630
Kaiser Permanente, Roseville
Roseville, California, 95661
Kaiser Permanente, Walnut Creek Medical Center
Walnut Creek, California, 94596
About this study
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.
Read the 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.
- Conditions
- Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder With Hyperactivity
- Being tested
- Quotient®, Usual Clinic ADHD Care
- Keywords
- Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder with Hyperactivity, Pediatrics, Patient Outcome Assessment
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quotient®Device
Also called OpTAX
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.
Usual Clinic ADHD CareBehavioural
Usual ADHD care as provided by the clinic
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Usual clinic ADHD care Receives: Behavioral: Usual Clinic ADHD Care |
| Usual Care plus Assessment | Experimental | Usual clinic ADHD care plus the Quotient® Receives: Device: Quotient® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month, 3 month and six month follow ups
Secondary outcomes (6)
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.
Measured: 6 months post baseline
Academic Performance
Academic performance will be measured by student report cards, and converted to a standardized scale
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit and Disruptive Behavior DisordersStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Pearson/Clinical Assessment
- Responsible party
- Sponsor
- Investigators
- Cynthia I Campbell, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094612
- Sponsor's protocol ID
- CN-13-1692-H
- Other IDs
- Quotient ADHD
- Status last verified
- Jun 2017
- First submitted
- 13 Mar 2014
- Last updated
- 17 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chinchilli VM, Fisher L, Craig TJ. Statistical issues in clinical trials that involve the double-blind, placebo-controlled food challenge. J Allergy Clin Immunol. 2005 Mar;115(3):592-7. doi: 10.1016/j.jaci.2005.01.008.
PubMed 15753909Clinical practice guideline: diagnosis and evaluation of the child with attention-deficit/hyperactivity disorder. American Academy of Pediatrics. Pediatrics. 2000 May;105(5):1158-70. doi: 10.1542/peds.105.5.1158.
PubMed 10836893Foy JM, Earls MF. A process for developing community consensus regarding the diagnosis and management of attention-deficit/hyperactivity disorder. Pediatrics. 2005 Jan;115(1):e97-104. doi: 10.1542/peds.2004-0953.
PubMed 15629972Herrerias CT, Perrin JM, Stein MT. The child with ADHD: using the AAP Clinical Practice Guideline. American Academy of Pediatrics. Am Fam Physician. 2001 May 1;63(9):1803-10.
PubMed 11352293Jensen PS, Garcia JA, Glied S, Crowe M, Foster M, Schlander M, Hinshaw S, Vitiello B, Arnold LE, Elliott G, Hechtman L, Newcorn JH, Pelham WE, Swanson J, Wells K. Cost-effectiveness of ADHD treatments: findings from the multimodal treatment study of children with ADHD. Am J Psychiatry. 2005 Sep;162(9):1628-36. doi: 10.1176/appi.ajp.162.9.1628.
PubMed 16135621Lachin JM, Foulkes MA. Evaluation of sample size and power for analyses of survival with allowance for nonuniform patient entry, losses to follow-up, noncompliance, and stratification. Biometrics. 1986 Sep;42(3):507-19.
PubMed 3567285Langberg JM, Froehlich TE, Loren RE, Martin JE, Epstein JN. Assessing children with ADHD in primary care settings. Expert Rev Neurother. 2008 Apr;8(4):627-41. doi: 10.1586/14737175.8.4.627.
PubMed 18416664Leslie LK, Weckerly J, Plemmons D, Landsverk J, Eastman S. Implementing the American Academy of Pediatrics attention-deficit/hyperactivity disorder diagnostic guidelines in primary care settings. Pediatrics. 2004 Jul;114(1):129-40. doi: 10.1542/peds.114.1.129.
PubMed 15231919Leslie LK, Wolraich ML. ADHD service use patterns in youth. J Pediatr Psychol. 2007 Jul;32(6):695-710. doi: 10.1093/jpepsy/jsm023. Epub 2007 Jun 7.
PubMed 17556401Shaw M, Hodgkins P, Caci H, Young S, Kahle J, Woods AG, Arnold LE. A systematic review and analysis of long-term outcomes in attention deficit hyperactivity disorder: effects of treatment and non-treatment. BMC Med. 2012 Sep 4;10:99. doi: 10.1186/1741-7015-10-99.
PubMed 22947230Pelham WE, Foster EM, Robb JA. The economic impact of attention-deficit/hyperactivity disorder in children and adolescents. J Pediatr Psychol. 2007 Jul;32(6):711-27. doi: 10.1093/jpepsy/jsm022. Epub 2007 Jun 7.
PubMed 17556402Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503.
PubMed 6354290Xie H, McHugo G, Drake R, Sengupta A. Using discrete-time survival analysis to examine patterns of remission from substance use disorder among persons with severe mental illness. Ment Health Serv Res. 2003 Mar;5(1):55-64. doi: 10.1023/a:1021759509176.
PubMed 12602646
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Quotient® ADHD Assessment in a System of Care
- ClinicalTrials.gov ID
- NCT02094612
- Acronym / sponsor ID
- CN-13-1692-H
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Pearson/Clinical Assessment
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Posted 17 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual Clinic ADHD CareUsual clinic ADHD care |
| Usual Care plus Assessment | Experimental | Device: Quotient®Usual clinic ADHD care plus the Quotient® |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Non English speaking
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quotient®Also: OpTAXPatients 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. | Device | Usual Care plus Assessment |
| Usual Clinic ADHD CareUsual ADHD care as provided by the clinic | Behavioural | Usual Care |
Primary outcome
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.
6 secondary outcomes
ADHD Symptomatology
Time frame: 6 months post baseline
Academic Performance
Time frame: Baseline and Six Months
Persistence in Care
Time frame: Baseline to Six Months
Medication Adherence
Time frame: Baseline to six months
Satisfaction With Care
Time frame: Six months
Other Health Services Use
Time frame: Baseline to six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15753909Chinchilli VM, Fisher L, Craig TJ. Statistical issues in clinical trials that involve the double-blind, placebo-controlled food challenge. J Allergy Clin Immunol. 2005 Mar;115(3):592-7. doi: 10.1016/j.jaci.2005.01.008.
- Background: PubMed 10836893Clinical practice guideline: diagnosis and evaluation of the child with attention-deficit/hyperactivity disorder. American Academy of Pediatrics. Pediatrics. 2000 May;105(5):1158-70. doi: 10.1542/peds.105.5.1158.
- Background: PubMed 15629972Foy JM, Earls MF. A process for developing community consensus regarding the diagnosis and management of attention-deficit/hyperactivity disorder. Pediatrics. 2005 Jan;115(1):e97-104. doi: 10.1542/peds.2004-0953.
- Background: PubMed 11352293Herrerias CT, Perrin JM, Stein MT. The child with ADHD: using the AAP Clinical Practice Guideline. American Academy of Pediatrics. Am Fam Physician. 2001 May 1;63(9):1803-10.
- Background: PubMed 16135621Jensen PS, Garcia JA, Glied S, Crowe M, Foster M, Schlander M, Hinshaw S, Vitiello B, Arnold LE, Elliott G, Hechtman L, Newcorn JH, Pelham WE, Swanson J, Wells K. Cost-effectiveness of ADHD treatments: findings from the multimodal treatment study of children with ADHD. Am J Psychiatry. 2005 Sep;162(9):1628-36. doi: 10.1176/appi.ajp.162.9.1628.
- Background: PubMed 3567285Lachin JM, Foulkes MA. Evaluation of sample size and power for analyses of survival with allowance for nonuniform patient entry, losses to follow-up, noncompliance, and stratification. Biometrics. 1986 Sep;42(3):507-19.
- Background: PubMed 18416664Langberg JM, Froehlich TE, Loren RE, Martin JE, Epstein JN. Assessing children with ADHD in primary care settings. Expert Rev Neurother. 2008 Apr;8(4):627-41. doi: 10.1586/14737175.8.4.627.
- Background: PubMed 15231919Leslie LK, Weckerly J, Plemmons D, Landsverk J, Eastman S. Implementing the American Academy of Pediatrics attention-deficit/hyperactivity disorder diagnostic guidelines in primary care settings. Pediatrics. 2004 Jul;114(1):129-40. doi: 10.1542/peds.114.1.129.
- Background: PubMed 17556401Leslie LK, Wolraich ML. ADHD service use patterns in youth. J Pediatr Psychol. 2007 Jul;32(6):695-710. doi: 10.1093/jpepsy/jsm023. Epub 2007 Jun 7.
- Background: PubMed 22947230Shaw M, Hodgkins P, Caci H, Young S, Kahle J, Woods AG, Arnold LE. A systematic review and analysis of long-term outcomes in attention deficit hyperactivity disorder: effects of treatment and non-treatment. BMC Med. 2012 Sep 4;10:99. doi: 10.1186/1741-7015-10-99.
- Background: PubMed 17556402Pelham WE, Foster EM, Robb JA. The economic impact of attention-deficit/hyperactivity disorder in children and adolescents. J Pediatr Psychol. 2007 Jul;32(6):711-27. doi: 10.1093/jpepsy/jsm022. Epub 2007 Jun 7.
- Background: PubMed 6354290Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia I Campbell, PhD principal investigator
Kaiser Permanente
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quotient® and Usual Clinic ADHD Care in people with Attention Deficit and Disruptive Behavior Disorders and Attention Deficit Disorder With Hyperactivity, run by Kaiser Permanente at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With 25% Reduction in SNAP Scores (time frame: One month, 3 month and six month follow ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02094612, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.