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| ID | Type | Description | Link |
|---|---|---|---|
| Quotient ADHD | Other Identifier | Abbreviated study title |
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| Name | Class |
|---|---|
| Pearson/Clinical Assessment | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Usual clinic ADHD care |
|
| Usual Care plus Assessment | Experimental | Usual clinic ADHD care plus the Quotient® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quotient® | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month, 3 month and six month follow ups |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia I Campbell, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente, Folsom | Folsom | California | 95630 | United States | ||
| Kaiser Permanente, Roseville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15753909 | Background | 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. | |
| 10836893 | Background | Clinical 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic |
| FG001 | Usual Care Plus Assessment | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic |
| BG001 | Usual Care Plus Assessment | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Fifty eight (58) participants completed the study (i.e., had their 6 month follow up appointment) when the study was terminated. | Posted | Count of Participants | Participants | One month, 3 month and six month follow ups |
|
6 months (from baseline to 6 month follow up)
Adverse events were assessed via periodic chart reviews of study participants..
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ashthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monique Does, Project manager | Kaiser Permanente Division of Research | 510-891-3612 | monique.does@kp.org |
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| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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|
| Usual Clinic ADHD Care | Behavioral | Usual ADHD care as provided by the clinic |
|
| 6 months post baseline |
| Academic Performance | Academic performance will be measured by student report cards, and converted to a standardized scale | 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 | 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 | 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 | 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. | Baseline to six months |
| Roseville |
| California |
| 95661 |
| United States |
| Kaiser Permanente, Walnut Creek Medical Center | Walnut Creek | California | 94596 | United States |
| 15629972 | Background | Foy 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. |
| 11352293 | Background | Herrerias 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. |
| 16135621 | Background | Jensen 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. |
| 3567285 | Background | Lachin 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. |
| 18416664 | Background | Langberg 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. |
| 15231919 | Background | Leslie 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. |
| 17556401 | Background | Leslie 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. |
| 22947230 | Background | Shaw 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. |
| 17556402 | Background | Pelham 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. |
| 6354290 | Background | Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503. |
| 12602646 | Background | Xie 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Usual Care Plus Assessment | 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. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | 6 months post baseline |
|
|
|
| Secondary | Academic Performance | Academic performance will be measured by student report cards, and converted to a standardized scale | 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). | Posted | Baseline and Six Months |
|
|
|
| Secondary | Persistence in Care | Update: Outcome measure reported is the # of participants who attended all study follow-up visits. Use of pediatric health care services | Posted | Count of Participants | Participants | Baseline to Six Months |
|
|
|
| Secondary | Medication Adherence | Update: Outcome reported is number of participants taking medication as prescribed at all study follow up visits. Sustained use of ADHD medication | Posted | Count of Participants | Participants | Baseline to six months |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Six months |
|
|
|
| Secondary | 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. | Posted | Number | visits | Baseline to six months |
|
|
|
| 0 |
| 112 |
| 1 |
| 112 |
| 0 |
| 112 |
| EG001 | Usual Care Plus Assessment | 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. | 0 | 95 | 0 | 95 | 0 | 112 |
|
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