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临床试验/NCT02296502
NCT02296502已完成不适用

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

University of Pittsburgh5 个研究点 分布在 1 个国家目标入组 439 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
439
试验地点
5
主要终点
Clinical Features of Concordant vs Discordant Groups

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • question of possible autism spectrum disorder

排除标准

  • <2 years old >17 years old

结局指标

主要结局

Clinical Features of Concordant vs Discordant Groups

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin L Handen, PhD, BCBA-D

Associate Professof of Psychiatry

University of Pittsburgh

研究点 (5)

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