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Comparison of DSM-IV-TR and DSM-5 for ASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02296502
Recruitment Status : Completed
First Posted : November 20, 2014
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Collaborators:
University of Missouri-Columbia
Children's Hospital Los Angeles
Nationwide Children's Hospital
Children's Hospital Medical Center, Cincinnati
Vanderbilt University
Information provided by (Responsible Party):
Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh

Brief Summary:
The study aim is to prospectively compare DSM-IV-TR and DSM-5 criteria for Autism Spectrum Disorder (ASD) in a sample of 250 children and adolescents who meet DSM-IV-TR criteria for ASD and 150 children and adolescents referred for diagnosis who do not meet DSM-IV-TR criteria.Families and children will be recruited from eight sites affiliated with the Autism Treatment Network (ATN). Participants must be between the ages of 2.0 and 17.11 years who undergo an ATN assessment at one of the eight sites. Both subjects who are found to meet criteria of ASD/PDD and those who do not meet criteria (after completing the ATN assessment) will be enrolled. After completing the standard ATN assessment, clinicians will complete a DSM-IV and DSM-5 checklist for ASD/PDD.

Condition or disease Intervention/treatment
Autism Spectrum Disorder Other: DSM

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Study Type : Observational
Actual Enrollment : 439 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of DSM-IV-TR and DSM-5 Diagnostic Criteria for Autism Spectrum Disorder
Study Start Date : November 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Autism Spectrum Disorder (DSM IV & 5)
All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in both DSM-IV and DSM-5
Other: DSM
Comparing use of DSM-IV versus DSM-5 criteria for autism spectrum disorder

Autism Spectrum Disorder (DSM 5 only)
All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-5 but not DSM-IV
Other: DSM
Comparing use of DSM-IV versus DSM-5 criteria for autism spectrum disorder

Autism Spectrum Disorder (DSM IV only)
All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-IV but not DSM-5
Other: DSM
Comparing use of DSM-IV versus DSM-5 criteria for autism spectrum disorder

Non-Autism Spectrum Disorder
All children and adolescents seen for autism diagnostic evaluations at the study sites who do not meet diagnostic criteria for ASD.
Other: DSM
Comparing use of DSM-IV versus DSM-5 criteria for autism spectrum disorder




Primary Outcome Measures :
  1. Clinical Features of Concordant vs Discordant Groups [ Time Frame: One day ]

    Clinical Features of Concordant versus Discordant Groups. Full Scale IQ: Stanford-Binet IQ test.(score range 40-160; higher = greater intellectual abilties)

    ABC = Aberrant Behavior Checklist, which includes:

    Irritability subscale: score range 0-45, higher = more problems. Social Withdrawal subscale: score range 0-48, higher = more problems. Stereotypic Behavior subscale: score range 0-21, higher = more problems. Hyperactivity/Noncompliance subscale: score range 0-48, higher = more problems. Inappropriate Speech subscale: score range 0-12, higher = more problems.

    CBCL = Child Behavior Checklist, which includes:

    Externalizing Problems and Internalizing problems: T scores less than 60 are considered in the normal range, 60-63 represent borderline scores, and scores greater than 63 are in the clinical range


  2. Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV Criteria [ Time Frame: day ]

    Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV Criteria

    Sensitivity refers to the ability of the DSM-5 to correctly identify those with ASD, whereas specificity is the ability of the DSM-5 to correctly identify those without ASD.




Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All children ages 2-17 who are being evaluated for a possible diagnosis of autism spectrum disorder
Criteria

Inclusion Criteria:

  • age 2-17
  • question of possible autism spectrum disorder

Exclusion Criteria:

  • <2 years old >17 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296502


Locations
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United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65201
United States, Ohio
Children's Hospital of Cincinnati
Cincinnati, Ohio, United States, 45229
Nationwide Children's Hospital
Columbus, Ohio, United States, 43081
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37240
Sponsors and Collaborators
University of Pittsburgh
University of Missouri-Columbia
Children's Hospital Los Angeles
Nationwide Children's Hospital
Children's Hospital Medical Center, Cincinnati
Vanderbilt University
Investigators
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Principal Investigator: Benjamin Handen, PhD University of Pittsburgh

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Responsible Party: Benjamin L Handen, PhD, BCBA-D, Associate Professof of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02296502    
Other Study ID Numbers: DSM5 and ASD
First Posted: November 20, 2014    Key Record Dates
Results First Posted: March 11, 2019
Last Update Posted: March 11, 2019
Last Verified: November 2018
Keywords provided by Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh:
DSM Diagnosis
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders