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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00579267
Other study ID # MINI-KID Validation Study
Secondary ID
Status Completed
Phase N/A
First received December 18, 2007
Last updated February 13, 2009
Start date February 2004
Est. completion date January 2008

Study information

Verified date December 2007
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 230
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 17 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms

  • ADHD
  • Alcohol Dependence
  • Alcoholism
  • Anxiety Disorders
  • Attention Deficit and Disruptive Behavior Disorders
  • Autistic Disorder
  • Child Development Disorders, Pervasive
  • Conduct Disorder
  • Depressive Disorder, Major
  • Developmental Disabilities
  • Disease
  • Drug Dependence
  • Dysthymia
  • Eating Disorders
  • Major Depression
  • Mania
  • Mental Disorders
  • Oppositional Defiant Disorder
  • Pervasive Developmental Disorder
  • Psychotic Disorder
  • Psychotic Disorders
  • Suicidality
  • Tourette Syndrome
  • Tourettes Disorder

Intervention

Other:
MINI-KID
Structured Diagnostic Interview for children and adolescent psychiatric disorders.

Locations

Country Name City State
United States University of South Florida College of Medicine, Department of Psychiatry Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Kappa scores between MINI Kid and K-SADS 4 years No
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