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

NCT ID: NCT02094612

Last Updated: 2017-07-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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

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Attention Deficit and Disruptive Behavior Disorders Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Usual Care

Usual clinic ADHD care

Group Type ACTIVE_COMPARATOR

Usual Clinic ADHD Care

Intervention Type BEHAVIORAL

Usual ADHD care as provided by the clinic

Usual Care plus Assessment

Usual clinic ADHD care plus the Quotient®

Group Type EXPERIMENTAL

Quotient®

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Usual Clinic ADHD Care

Usual ADHD care as provided by the clinic

Intervention Type BEHAVIORAL

Other Intervention Names

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OpTAX

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pearson/Clinical Assessment

INDUSTRY

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cynthia I Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente, Folsom

Folsom, California, United States

Site Status

Kaiser Permanente, Roseville

Roseville, California, United States

Site Status

Kaiser Permanente, Walnut Creek Medical Center

Walnut Creek, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15753909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10836893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15629972 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11352293 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16135621 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3567285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18416664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15231919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17556401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22947230 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17556402 (View on PubMed)

Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503.

Reference Type BACKGROUND
PMID: 6354290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12602646 (View on PubMed)

Other Identifiers

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Quotient ADHD

Identifier Type: OTHER

Identifier Source: secondary_id

CN-13-1692-H

Identifier Type: -

Identifier Source: org_study_id

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