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Clinical Trial Details
Information Technology Enabled Management System for Treatment of Adolescent Depression.
Clinical Trial ( IRB ) #: 12-077-3
Title: Information Technology Enabled Management System for Treatment of Adolescent Depression.
Principal Investigator: Dr. Daniel Connor
Description: This phase II randomized study proposes to evaluate a field trial for web-enhanced and computer assisted telephone delivery of Cognitive Behavioral Therapy (CBT) of Major Depressive Disorder (MDD) in adolescents. The target population will consist of teens age 12-17, inclusive with MDD. Phase II continues developing theā€œInformation Technology Enabled Disease Management System for Treatment of Adolescent Depression (ITEMS-TAD) which began its development on Phase I. The following specific aims for Phase II will be achieved: 1) content for the remaining 13 modules of the ITEMS-TAD program will be developed; 2) a rapid iterative evaluation & testing (RITE) study will be undertaken to refine the content of the new modules with continued assessment of usability of the technology involved in its delivery; 3) a pilot efficacy study will be run to evaluate preliminary indicators of efficacy related to the ITEMS-TAD approach; 4) a satisfaction and acceptance study will be completed to assess satisfaction and acceptance of the approach from the point of view of patients and providers; 5) the modules and related content for the full version of the proposed Phase II ITEMS-TAD will be outlined and elaborated, and 6) the research and production design to be implemented in Phase II will be complete. The primary outcome of interest will be changes in measures of depression among adolescents with Major Depressive Disorder (MDD). The design will be longitudinal in nature with an average of 12 ITEMS-TAD CBT sessions during which depression will be measured and compared to conventional methods. In addition to primary outcomes measure (depression) study will assess preliminary indicators of program feasibility and efficacy. In particular, the study will assess the quality and fidelity of the administered CBT interviews, the nature of the initial alliance that may develop between disease managers and adolescents using the system, and preliminary indicators of the effectiveness with which the program can teach basic cognitive behavioral skills. This study expects to enroll 150 subjects with MDD and their caregiver, with 75 subjects to participate in the ITEMS-TADS and 2-4 subjects in the RITEUCHC at the UCHC site.
Classification:
  Psychiatry - Child and Adolescent
Eligibility Criteria: Check with study contact
How to Contact: Rocio Chang. Telephone: (860)-679-1728. Email: chang@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.