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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02094612
• Other study ID #: CN-13-1692-H
• Secondary ID: Quotient ADHD
• Status: Terminated
• Phase: N/A
• First received: March 13, 2014
• Last updated: March 4, 2016
• Start date: March 2014
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 206
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder With Hyperactivity
• Disease
• Hyperkinesis
• Mental Disorders

Intervention

Device:
• 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.

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

Locations

Country	Name	City	State
United States	Kaiser Permanente, Folsom	Folsom	California
United States	Kaiser Permanente, Roseville	Roseville	California
United States	Kaiser Permanente, Walnut Creek Medical Center	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Pearson/Clinical Assessment

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Leslie LK, Wolraich ML. ADHD service use patterns in youth. J Pediatr Psychol. 2007 Jul;32(6):695-710. Epub 2007 Jun 7. Review. — View Citation

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. Epub 2007 Jun 7. Review. — View Citation

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

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. Review. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to therapeutic dose	The primary outcome measure will be change in the dose of ADHD medication as measured across three followup time points, comparing a Usual Care group and a Quotient test group. The hypothesis is that patients who receive the Quotient test (the computerized neuroassessment) will reach a stable therapeutic dose of ADHD medication more quickly, compared to Usual Care.	One month, 3 month and six month follow ups	No
Secondary	ADHD Symptomatology	ADHD symptomatology measured by the SNAP-IV	1, 3 and 6 months post baseline	No
Secondary	Academic Performance	Academic performance will be measured by student report cards, and converted to a standardized scale	Baseline and Six Months	No
Secondary	Persistence in Care	Use of pediatric health care services	Baseline to Six Months	No
Secondary	Medication Adherence	Sustained use of ADHD medication	Baseline to six months	No
Secondary	Satisfaction with care	Likert scale single item measure of how satisfied the pediatric patient's parent was with care received	Six months	No
Secondary	Other health services use	Use of healthcare services outside of pediatrics, including the emergency room and psychiatric services.	Baseline to six months	No