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Clinical Trials/NCT02296502
NCT02296502CompletedNot Applicable

Comparison of DSM-IV-TR and DSM-5 Diagnostic Criteria for Autism Spectrum Disorder

University of Pittsburgh5 sites in 1 country439 target enrollmentStarted: November 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
439
Locations
5
Primary Endpoint
Clinical Features of Concordant vs Discordant Groups

Study Overview

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.

Detailed Description

The study will involve the following aims and hypotheses:

Aim 1: To prospectively compare DSM-IV-TR and DSM-5 criteria for Autism Spectrum Disorder in a sample of 250 children and adolescents who meet DSM-IV-TR criteria for ASD.

Aim 2: To examine the impact of IQ, comorbid behavior problems, age and ASD symptom severity on the specificity and sensitivity of DSM-5 diagnostic criteria.

Hypothesis 1: DSM-5 diagnostic criteria will have good specificity but poor sensitivity when comparing results with DSM-IV-TR ASD diagnostic criteria.

Hypothesis 2: Lower IQ will be associated with higher DSM-IV/DSM-5 concordance.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • question of possible autism spectrum disorder

Exclusion Criteria

  • <2 years old >17 years old

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Benjamin L Handen, PhD, BCBA-D

Associate Professof of Psychiatry

University of Pittsburgh

Study Sites (5)

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