This Phase II SBIR proposes to expand upon our successful Phase I activities to finalize development and test the efficacy of an innovative computer-based treatment-delivery product for children with Chronic Tic Disorders (CTD;including Tourette Disorder) and their families. CTD represents a class of neuropsychiatric disorders, occurring in 0.6-3% of school-aged children that can lead to significant impairments in physical, social, academic, and interpersonal functioning and reduced quality of life. Currently, there is no cure for CTD, however in large-scale randomized controlled trials, a non-pharmacological treatment known as Comprehensive Behavioral Interventions for Tics (CBIT) was shown to reduce tics without the adverse side effects associated with pharmacotherapy. A therapist-guided, empirically validated CBIT protocol is available, however the vast majority of individuals who desire CBIT do not have access to therapists trained in the delivery of this intervention. Given the need for non-pharmacological treatment options for children with CTD, a desire for such treatments by potential end-users, and the absence of practitioners adequately trained in the treatment, there is a clear need for innovative modes of dissemination. Following our recently completed (and successful) Phase I project, the current proposal partners two of the primary developers of the CBIT intervention with PsycTech Ltd., to finalized development and test a highly accessible and relatively inexpensive computerized self-help version of CBIT. Results from our Phase I project demonstrated that a prototype version of TICHELPER received high ratings from both professionals and end-users (children with CTD and their parents) on indices of feasibility, acceptability, and usability. Results from the Phase I pilot study also show that TICHELPER was effective for reducing core CTD symptoms. Phase I results strongly justify Phase II, during which we will fully develop and test the efficacy of TicHelper. This Phase II proposal aims to (1) use an iterative feedback process with end-users to develop the remaining core components of the CBIT protocol (i.e., relaxation training, function-based intervention, and the fully developed habit reversal module to address core CTD symptoms) into a self-administered online format, and (2) to compare the efficacy of TICHELPER to an Internet-Based Resources (IBR) condition in a randomized controlled trial. !

Public Health Relevance

Chronic Tic Disorders (CTD;including Tourette Disorder) occur in .6-3% of school-age children and often lead to significant psychosocial and physical impairment and diminished quality of life. Medication management options exist, but parents are often reluctant to utilize such treatments with children due to potential side effects. Effective non-pharmacological treatment options exist and are desired by parents, but are often difficult to access due to a lack of trained providers and high upfront costs. The current project proposes to develop a highly accessible and relatively inexpensive computerized self-help version of a successful behavioral treatment for tics (i.e., Comprehensive Behavioral Intervention for Tics;CBIT). Building off our successful Phase I project, this Phase II proposal will complete the development of the TICHELPER program and test its efficacy in a randomized clinical trial. !

Agency
National Institute of Health (NIH)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44MH096344-02
Application #
8648060
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Haim, Adam
Project Start
Project End
Budget Start
Budget End
Support Year
2
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Psyc Tech, Ltd
Department
Type
DUNS #
City
Houston
State
TX
Country
United States
Zip Code
77098