Major DepressionNCT00579267
Reliability and Validity of the MINI International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
An observational study of Major Depression and Mania, run by University of South Florida at 1 site in United States.
Trial summary
The primary aims of this study are to assess: 1. The inter-rater and test-retest reliability of the MINI-KID 2. The validity of the standard MINI-KID interview in relation to the parent rated pencil/paper version (MINI-KID-P) and th longer clinician rated "Schedule for Affective Disorders and Schizophrenia for School… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression, Mania, Anxiety Disorders
- What is being tested?
- MINI-KID
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Jan 2008
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children and adolescents between the ages of 6 and 18 years.
Who may be able to join
- Subjects will be between the ages of 6 years and 17 years, 11 months
- All subjects must meet MINI-KID DSM-IV criteria for a least one of the Axis I child psychiatry disorders covered by the MINI-KID.
- Both sexes are included.
Who cannot join
- Subjects who suffer from mental retardation, significant developmental disorders, congenital abnormalities, delirium, dementia, a language problem, or brain damage will be excluded.
- Subjects with neurological disorders, chronic or life threatening diseases will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Florida College of Medicine, Department of Psychiatry
Tampa, Florida, 33613-4788
About this study
The primary aims of this study are to assess:
- The inter-rater and test-retest reliability of the MINI-KID
- The validity of the standard MINI-KID interview in relation to the parent rated pencil/paper version (MINI-KID-P) and th longer clinician rated "Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) and "expert opinion" (when available).
Secondary aims will include evaluating the concordance between: The Children's Global Assessment Scale (a required part of the K-SADS) with the clinician-rated Sheehan Disability Scale (to be administered with the MINI-KID) as a measure of illness severity.
Read the detailed description
The MINI-KID is a short, structured diagnostic interview used to assess the presence of 24 DSM-IV child and adolescent psychiatric disorders as well as the risk of suicide.
To achieve adequate representation of the major psychiatric disorders and sufficient normal controls, we propose recruiting 230 children and adolescents (ages 6 to 17 years 11 months), comprised of 200 subjects identified as having one or more psychiatric disorders and 30 normal controls in the community. These subjects will be from diverse socioeconomic, racial and ethnic backgrounds. We will assess the inter-rater and test-retest reliability of the MINI-KID and examine its validity with the "gold-standard" diagnostic interview for children and adolescents as well as expert opinion.
- Conditions
- Major Depression, Mania, Anxiety Disorders, Psychotic Disorder, Alcohol Dependence, Drug Dependence
- Being tested
- MINI-KID
- Keywords
- MINI-KID, structured diagnostic interview, reliability and validity, K-SADS, Sheehan Disability Scale
- Medical subject headings
- Depressive Disorder, Major, Mania, Anxiety Disorders, Psychotic Disorders, Alcoholism, Substance-Related Disorders, Feeding and Eating Disorders, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINI-KIDOther
Structured Diagnostic Interview for children and adolescent psychiatric disorders.
What is being measured
The primary outcome is the main question the study is designed to answer.
Kappa scores between MINI Kid and K-SADS
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startFeb 2004
- Primary completionJan 2008
- Study completionJan 2008
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 Major DepressionStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Investigators
- David V. Sheehan, MD, MBA, Principal investigator, University of South Florida College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579267
- Sponsor's protocol ID
- MINI-KID Validation Study
- Status last verified
- Dec 2007
- First submitted
- 18 Dec 2007
- Last updated
- 16 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Sheehan DV, Sheehan KH, Shytle RD, Janavs J, Bannon Y, Rogers JE, Milo KM, Stock SL, Wilkinson B. Reliability and validity of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). J Clin Psychiatry. 2010 Mar;71(3):313-26. doi: 10.4088/JCP.09m05305whi.
PubMed 20331933
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the MINI International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
- ClinicalTrials.gov ID
- NCT00579267
- Acronym / sponsor ID
- MINI-KID Validation Study
- Conditions
- Major Depression, Mania, Anxiety Disorders, Psychotic Disorder, Alcohol Dependence, Drug Dependence
- Keywords
- MINI-KID, structured diagnostic interview, reliability and validity, K-SADS, Sheehan Disability Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 24 Dec 2007 (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 primary aims of this study are to assess:
- The inter-rater and test-retest reliability of the MINI-KID
- The validity of the standard MINI-KID interview in relation to the parent rated pencil/paper version (MINI-KID-P) and th longer clinician rated "Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) and "expert opinion" (when available).
Secondary aims will include evaluating the concordance between: The Children's Global Assessment Scale (a required part of the K-SADS) with the clinician-rated Sheehan Disability Scale (to be administered with the MINI-KID) as a measure of illness severity.
Detailed description
The MINI-KID is a short, structured diagnostic interview used to assess the presence of 24 DSM-IV child and adolescent psychiatric disorders as well as the risk of suicide.
To achieve adequate representation of the major psychiatric disorders and sufficient normal controls, we propose recruiting 230 children and adolescents (ages 6 to 17 years 11 months), comprised of 200 subjects identified as having one or more psychiatric disorders and 30 normal controls in the community. These subjects will be from diverse socioeconomic, racial and ethnic backgrounds. We will assess the inter-rater and test-retest reliability of the MINI-KID and examine its validity with the "gold-standard" diagnostic interview for children and adolescents as well as expert opinion.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children and adolescents between the ages of 6 and 18 years.
Key inclusion criteria (3 listed)
- Subjects will be between the ages of 6 years and 17 years, 11 months
- All subjects must meet MINI-KID DSM-IV criteria for a least one of the Axis I child psychiatry disorders covered by the MINI-KID.
- Both sexes are included.
Key exclusion criteria (2 listed)
- Subjects who suffer from mental retardation, significant developmental disorders, congenital abnormalities, delirium, dementia, a language problem, or brain damage will be excluded.
- Subjects with neurological disorders, chronic or life threatening diseases will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MINI-KIDStructured Diagnostic Interview for children and adolescent psychiatric disorders. | Other | – |
Primary outcome
Kappa scores between MINI Kid and K-SADS
Time frame: 4 years
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 16 Feb 2009.
- Derived from this study: PubMed 20331933Sheehan DV, Sheehan KH, Shytle RD, Janavs J, Bannon Y, Rogers JE, Milo KM, Stock SL, Wilkinson B. Reliability and validity of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). J Clin Psychiatry. 2010 Mar;71(3):313-26. doi: 10.4088/JCP.09m05305whi.
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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.
David V. Sheehan, MD, MBA principal investigator
University of South Florida College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depression and Mania, run by University of South Florida at 1 site 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 3 inclusion and 2 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 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Kappa scores between MINI Kid and K-SADS (time frame: 4 years). 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 NCT00579267, 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 16 Feb 2009.