- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01866956
Computerized Screening for Comorbidity in Adolescents With Substance or Psychiatric Disorders
January 22, 2020 updated by: Kenneth A. Kobak, Ph.D., Center for Psychological Consultation
The KSADS-COMP will facilitate identification of comorbid psychiatric and substance use diagnoses frequently missed in clinical practice, and improve adolescent treatment outcomes.
The self-administered version of the KSADS-COMP can also be used cost-effectively 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.
Study Overview
Status
Completed
Conditions
Detailed Description
This Phase II SBIR grant is a follow-up to the Phase I SBIR grant "Computerized Screening for Comorbidity in Adolescents with Substance or Psychiatric Disorders."
During Phase I, parent and adolescent self administered computerized versions of the psychiatric interview, the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), were developed to assess DSM-IVR diagnoses in adolescents.
Since the funding of the Phase I grant, there have been two significant developments 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 parent and adolescent 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 KSADS- 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.
Ultimately the aim of this initiative is to create an instrument that, in addition to providing a reliable comprehensive assessment tool for psychiatric disorders in adolescents, can bridge DSM-5 and RDoC diagnostic perspectives.
A sample of 400 adolescents and their parents will be recruited for this study: half will complete the self-administered KSADS-COMP; the other half will complete the clinician-administered KSADSCOMP.
All 400 adolescents and their parents, in addition to completing one of the KSADS-COMP versions, will also complete a battery of dimensional symptom rating scales.
A subset of 210 adolescents and their parents will then complete the other version of the KSADS-COMP to test diagnostic concordance between the self- and clinician-administered KSADS-COMP.
To obtain reliable Kappa estimates, this subset will include 30 adolescents with no psychopathology and 30 adolescents that meet criteria for each of the following diagnoses: conduct disorder, major depression, bipolar; substance use disorders; post traumatic stress disorder; and attention deficit hyperactivity disorder.
This subset of 210 adolescents will also be administered the RDoC battery of neurocognitive computerized tasks.
The KSADS-COMP and KSADS-Bridge assessment tools will have multiple clinical and research applications.
In addition to helping identify comorbidity in teens with substance or psychiatric disorders, it will help to create the cross-talk needed between the DSM and RDoC diagnostic perspectives, and will help to improve clinical care in the short- and long-run as the field aims to transition to a new psychiatric nomenclature.
Study Type
Observational
Enrollment (Actual)
223
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21205
- Hugo W. Moser Research Institute at Kennedy Krieger
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adolescents aged 13-18 seeking psychiatric treatment at a rural mental health clinic
Description
Inclusion Criteria:
- adolescent between the ages of 11 and 17
Exclusion Criteria:
- Children will be excluded if they have a diagnosis of mental retardation (IQ < 70) or a severe psychosis that would impair the child's ability to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wilcoxon rank sum tests.
Time Frame: within 2 days of criterion measure
|
compare scores on disorder-specific symptom rating scales between those with and without a specific diagnoses
|
within 2 days of criterion measure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
April 30, 2018
Study Registration Dates
First Submitted
May 29, 2013
First Submitted That Met QC Criteria
May 31, 2013
First Posted (Estimate)
June 3, 2013
Study Record Updates
Last Update Posted (Actual)
January 27, 2020
Last Update Submitted That Met QC Criteria
January 22, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R43MH094092 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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