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Clinical Trial Summary

Nearly 9 million U.S. children (1 in 8) meet criteria for at least one mental health disorder at any point in time. Effective treatments exist for these disorders, but children and families who seek services rarely receive them; mental health providers need more support in the delivery of these interventions to ensure that children and families are receiving the best quality care. This project aims to improve the delivery of best practices for families who seek mental health care by developing creative, technology-based resources for providers. Once we have completed development of the tablet-based resources, we will conduct a small randomized study with 20 families to examine the feasibility and prepare for a large study to test the effectiveness of the resources.


Clinical Trial Description

Efficacious treatments exist for a wide range of psychiatric disorders, but these treatments rarely are delivered with high fidelity in mental health service settings. Research is needed to ensure that these treatments become more accessible in day-to-day clinical care. Innovative, low-cost approaches are essential, particularly in settings where resources are limited. Technological advances have made possible the development of low-cost and highly efficient (i.e., minimal time burden to providers) resources that can be delivered via internet, tablets, Smartphone, and other technologies to improve quality of care. Research is needed to inform these efforts and evaluate the feasibility and utility of this approach. Widespread availability of technology-based resources may represent an important step toward making evidence-based treatment more accessible to children and adults if research supports their utility. Our research team has led the development and evaluation of several e-health and e-learning tools for patients and providers. This has positioned us well to develop and rigorously evaluate a technology-based toolkit to enhance providers' delivery of evidence-based treatment. Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), an empirically supported treatment for children with posttraumatic stress reactions, is widely used by community providers and is ideal for testing the use of technology-based resources because the protocol addresses multiple symptom domains as well as both children and caregivers. We propose to develop and examine the feasibility of a technology-based toolkit for TF-CBT (e-TFCBT) that is designed to enhance the quality, accessibility, and efficacy of treatment. The toolkit will consist of web-based applications that are optimized for use on mobile devices. We conducted an interview of 21 nationally certified trainers in TF-CBT to guide an initial list of resources that are intended to address known problems with fidelity and engagement. Providers will use most of these resources in session to maximize fidelity and enhance child engagement and learning. The resources will be alpha-tested with families and providers and then beta-tested with providers; qualitative data will be used to guide refinements to the toolkit. We will then conduct a feasibility trial with 20 families. Results will provide valuable preliminary data in preparation for a randomized controlled trial to examine the additive benefits of web-accessible resources that assist providers in high-fidelity delivery of evidence-based care. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01915160
Study type Interventional
Source Medical University of South Carolina
Contact
Status Completed
Phase N/A
Start date November 2013
Completion date August 2016

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