This Phase II SBIR application proposes continued development of an Information Technology Enabled Disease Management System for Treatment of Adolescent Depression (ITEMS-TAD) following a highly successful Phase I award in which all Specific Aims were met. The need for this system innovation arises from the substantial costs that inadequately treated adolescent Major Depressive Disorder (MDD) has on the course of adolescent development and society as a whole. Effective treatments involving the combined use of a Selective Serotonin Reuptake Inhibitor (SSRI) and the administration of Cognitive Behavioral Therapy (CBT) is considered the "modal treatment" for adolescent MM. Yet, multiple barriers interfere with the implementation and dissemination of this "gold standard'of care. These barriers include: under recognition of depressive symptoms by parents and pediatricians, inability to assess adolescent depression accurately and reliably in primary care settings, safety concerns related to pharmacologic treatment, monitoring of symptom changes and adverse treatment effects, such as irritability and suicidal behavior, treatment non-compliance, lack of access to an integrated medical and treatment history;and an alarming shortage of properly trained child and adolescent psychiatrists capable of implementing optimal treatment safely, reliably, and effectively. With an emphasis on making tailored forms of CBT broadly and easily accessible to the community, the ITEMS-TAD is intended to address these problems. Development of the system will continue by building onto the existing prototype created with funding from federal sources. The technological infrastructure of the prototype includes a Computer Assisted Telephone Interview (CATI) platform, a database consisting of patients'real time medical and treatment history, and an underlying set of intelligent algorithms that tailors the intensity of the treatment resources and approaches administered in individual cases. When interacting with patients over the telephone, primary care nurses use the CATI to facilitate the reliable assessment of patient status and administer manualized, empirically informed interventions. Phase I focused on the development and testing of a demo system that embodies critical features of this approach. The following specific aims will be achieved in Phase II: (1) content for the remaining ITEMS-TAD program will be developed;(2) a Rapid Iterative Evaluation &Testing (RITE) study will be undertaken to refine the content of the application and assess the usability of the technology involved in its delivery;(3) a field trial will be run to evaluate empirically indicators of efficacy and patient acceptance related to the ITEMS-TAD approach.

Public Health Relevance

The lifetime prevalence of Major Depressive Disorder (MDD) among adolescents is extremely high, with substantial costs for individual adolescents, their families, and society. Effective "gold standard" treatments have been developed for MDD, yet multiple barriers interfere with its availability and delivery on a wide scale basis. This request for Phase II funding continues a highly successful Phase I project that will continue to develop an innovative IT-based administration and management system optimizing adolescent depression care for large segments of the population.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44MH085350-03
Application #
8212037
Study Section
Special Emphasis Panel (ZRG1-BBBP-T (10))
Program Officer
Haim, Adam
Project Start
2009-03-12
Project End
2014-12-31
Budget Start
2012-01-01
Budget End
2014-12-31
Support Year
3
Fiscal Year
2012
Total Cost
$395,723
Indirect Cost
Name
Veritas Health Solutions, LLC
Department
Type
DUNS #
151070286
City
Wayland
State
MA
Country
United States
Zip Code
01778