This is a supplemental (renewal) grant to the Phase II SBIR grant ?Computerized Screening for Comorbidity in Adolescents with Substance or Psychiatric Disorders.? Since the funding of the Phase I grant, two significant developments occurred in the field: the American Psychiatric Association?s release of the DSM-5 manual, and NIMH?s launch of the Research Domain Criteria (RDoC) initiative that aims to create the necessary database to derive a new psychiatric nomenclature informed by neuroscience, genetics, and psychology. The primary goals of Phase II include: 1) Update the self-administered computerized KSADS (KSADS-COMP) so it is compatible with DSM-5 criteria; 2) Develop software for a clinician-administered computerized KSADS (KSADS-COMP); 3) Create a K-SADS-Bridge product that includes a battery of RDoC computerized neurocognitive tasks that can be completed with the self- or clinician-administered KSADS-COMP; and 4) Examine the criterion, convergent, and discriminant validity of the self-administered KSADS-COMP, and the relationship among DSM-5 diagnoses, dimensional measures of psychopathology, and performance on RDoC neurocognitive tasks. In addition to providing a reliable comprehensive assessment tool for adolescents, our goal is to provide an instrument that can ?bridge? DSM-5 and RDoC diagnostic perspectives, which can be used to generate a database on the relationship between RDoC constructs, DSM classifications, dimensional measures of psychopathology and treatment outcomes across a range of diagnostic categories. Since our phase II funding, we have received numerous requests from pharmaceutical companies and NIMH funded researchers for use of the clinician-administered KSADS-COMP in large, multi-center and multi-national national trials. The latter required the translation of the KSADS into several different languages, which are currently not available. They have also requested the ability to customize the KSADS, so that researchers could choose specific modules to administer for non-diagnostic study-specific research purposes. To respond to these demands and help facilitate the uptake of the KSADS, in Phase IIB, we propose to translate the KSADS into Spanish (one of the most common languages used in clinical trials with adolescents) using ISPOR approved process for linguistic validation, including dual forward translation and reconciliation, single back translation and review, review by subject matter expert, and cognitive debriefing. We will also create the programming infrastructure to facilitate future translations. These enhancements will facilitate its use in research studies around the world, thus creating a richer data base for empirical examination of new psychiatric nomenclature, and enhancing its commercial viability. In Phase IIB we will also restructure the interview to allow the clinician to customize which diagnostic models to administer, which will greatly enhance its clinical and research utility.

Public Health Relevance

The KSADS-COMP will facilitate identification of comorbid psychiatric and substance use diagnoses frequently missed in clinical practice, and improve adolescent treatment outcomes. It provides a cost-effective too for use in schools and juvenile justice settings where there is a growing interest in early identification and referral of youth in need of mental health services. The KSADS-Bridge assessment tool with its RDoC neurocognitive tasks, when completed with the self- or clinician administered KSADS-COMP, will help to create cross-talk between the DSM and RDoC diagnostic perspectives, and begin to generate a database on the relationship between RDoC constructs and treatment outcomes across a range of diagnostic categories. The addition of a Spanish version in Phase IIB will enable its use with non-English speakers, facilitating its use in research studies around the world, thus enriching the research database and an expanding its clinical applications.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44MH094092-06A1
Application #
9253667
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Haim, Adam
Project Start
2011-04-01
Project End
2019-04-30
Budget Start
2018-05-01
Budget End
2019-04-30
Support Year
6
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Center for Psychological Consultation
Department
Type
DUNS #
616223769
City
Madison
State
WI
Country
United States
Zip Code
53717