Psychiatric DisorderNCT01866956
Computerized Screening for Comorbidity in Adolescents With Substance or Psychiatric Disorders
An observational study of Psychiatric Disorder, run by Center for Psychological Consultation at 2 sites in United States.
Trial summary
The KSADS-COMP will facilitate identification of comorbid psychiatric and substance use diagnoses frequently missed in clinical practice, and improve adolescent treatment outcomes. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Psychiatric Disorder
- How many people
- 223 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2016to 30 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: adolescents aged 13-18 seeking psychiatric treatment at a rural mental health clinic
Who may be able to join
- adolescent between the ages of 11 and 17
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hugo W. Moser Research Institute at Kennedy Krieger
Baltimore, Maryland, 21205
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Psychiatric Disorder
- Medical subject headings
- Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Wilcoxon rank sum tests.
compare scores on disorder-specific symptom rating scales between those with and without a specific diagnoses
Measured: within 2 days of criterion measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study start1 Sep 2016
- Primary completion1 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Psychological Consultation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Pittsburgh, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Child Mind Institute
- Responsible party
- Principal investigator, Kenneth A. Kobak, Ph.D., Center for Psychological Consultation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866956
- Sponsor's protocol ID
- 1R43MH094092
- Other IDs
- 1R43MH094092
- Status last verified
- Jan 2020
- First submitted
- 29 May 2013
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Townsend L, Kobak K, Kearney C, Milham M, Andreotti C, Escalera J, Alexander L, Gill MK, Birmaher B, Sylvester R, Rice D, Deep A, Kaufman J. Development of Three Web-Based Computerized Versions of the Kiddie Schedule for Affective Disorders and Schizophrenia Child Psychiatric Diagnostic Interview: Preliminary Validity Data. J Am Acad Child Adolesc Psychiatry. 2020 Feb;59(2):309-325. doi: 10.1016/j.jaac.2019.05.009. Epub 2019 May 18.
PubMed 31108163
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Screening for Comorbidity in Adolescents With Substance or Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT01866956
- Acronym / sponsor ID
- 1R43MH094092
- Conditions
- Psychiatric Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Center for Psychological ConsultationUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Pittsburgh, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Child Mind Institute
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 3 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- adolescents aged 13-18 seeking psychiatric treatment at a rural mental health clinic
Key inclusion criteria (1 listed)
- adolescent between the ages of 11 and 17
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Background: PubMed 31108163Townsend L, Kobak K, Kearney C, Milham M, Andreotti C, Escalera J, Alexander L, Gill MK, Birmaher B, Sylvester R, Rice D, Deep A, Kaufman J. Development of Three Web-Based Computerized Versions of the Kiddie Schedule for Affective Disorders and Schizophrenia Child Psychiatric Diagnostic Interview: Preliminary Validity Data. J Am Acad Child Adolesc Psychiatry. 2020 Feb;59(2):309-325. doi: 10.1016/j.jaac.2019.05.009. Epub 2019 May 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder, run by Center for Psychological Consultation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wilcoxon rank sum tests. (time frame: within 2 days of criterion measure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01866956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.