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

NCT02094612 | Terminated Results DMC

• 2 other identifiers: CN-13-1692-HQuotient ADHD
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• ADHD Symptomatology

  6 months post baseline

• Academic Performance

  Baseline and Six Months

• Persistence in Care

  Baseline to Six Months

• Medication Adherence

  Baseline to six months

• Satisfaction With Care

  Six months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Usual clinic ADHD care

Behavioral: Usual Clinic ADHD Care

Usual Care plus Assessment

EXPERIMENTAL

Usual clinic ADHD care plus the Quotient®

Device: Quotient®

Interventions

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.

Also known as: OpTAX

Usual Care plus Assessment

Usual Clinic ADHD Care BEHAVIORAL

Usual ADHD care as provided by the clinic

Usual Care

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Non English speaking
• Refusal to participate

Sponsors & Collaborators

• Kaiser Permanente: lead
• Pearson/Clinical Assessment: collaborator

Study Sites (3)

Kaiser Permanente, Folsom

Folsom, California, 95630, United States

Location

Kaiser Permanente, Roseville

Roseville, California, 95661, United States

Location

Kaiser Permanente, Walnut Creek Medical Center

Walnut Creek, California, 94596, United States

Location

Related Publications (13)

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• 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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  PMID: 15629972 BACKGROUND

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  PMID: 11352293 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.

  PMID: 16135621 BACKGROUND

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• 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.

  PMID: 18416664 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.

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  PMID: 22947230 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.

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  PMID: 6354290 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.

  PMID: 12602646 BACKGROUND

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Monique Does, Project manager
• Organization: Kaiser Permanente Division of Research

monique.does@kp.org

510-891-3612

Study Officials

• Cynthia I Campbell, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 24, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 17, 2017
• Results First Posted: July 17, 2017

Record last verified: 2017-06

Locations

US (3)