Comparison of DSM-IV-TR and DSM-5 for ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Observational

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.

      METHODS

      Families and children will be recruited from seven sites affiliated with the Autism Treatment
      Network. An IRB submission and consent form will be developed for each of the participating
      programs. Parents (along with child assent and/or consent, depending upon the study site)
      will sign informed consent to participate in the study. Participants must be between the ages
      of 2.0 and 17.11 years who undergo an ATN assessment at one of the seven 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. Therefore, the only inclusion criteria will
      be that the child be between 2.0 and 17.11 years of age and be referred for an ATN diagnostic
      evaluation. The only exclusion criteria will be when the ADOS is determined by the clinician
      to be "invalid." Examples may include a child who is extremely non-compliant, severely
      depressed, or unresponsive. The following measures will be obtained:

      ADOS:

      All participants will be administered the Autism Diagnostic Observation Schedule 2 (Lord et
      al., 2012). The ADOS2 is a standardized, interactive protocol for direct observation (45
      minutes) of social and communicative behavior associated with ASD, and consists of structured
      and semi-structured methods for interaction. This assessment tool is designed to assess a
      wide range of children and adolescents, from nonverbal/barely verbal children to adolescents
      and adults with fluent speech.

      Assessment of IQ:

      All participants will have an updated assessment of full IQ using any one of the following
      tools: the Stanford-Binet V (Roid, 2003), Wechsler Intelligence Scales for Children IV
      (Wechsler, 2003), the Wechsler Preschool and Primary Scale of Intelligence - Third Edition
      (Wechsler, 2002), Differential Ability Scales, 2nd Edition, (Elliot, 2007), Wechsler
      Abbreviated Scale of Intelligence 2 (Wechsler, 2011) or Mullen Scales of Early Learning AGS
      Edition (Mullen, 1989). If a child has had a full-scale IQ assessment conducted within one
      year, this will be accepted in place of an updated evaluation.

      Assessment of Behavior:

      Child Behavior Checklist (CBCL): The CBCL (Achenbach 2001; Achenbach & Rescorla, 2000) is a
      parent completed questionnaire comprising of 100 items (scored on a 3-point likert scale from
      "not true" to "very true or often true"). There is a preschool version (1.5-5 years) and a
      school version (6-18 years). A range of subscales are derived, including externalizing and
      internalizing disorders as well as more specific co-morbidities such as anxiety, ADHD and
      PDD.

      Aberrant Behavior Checklist (ABC). The ABC (Aman & Singh, 1986) is a standardized scale
      comprising 58 items, for assessing problem behavior in subjects with developmental
      disabilities. The ABC was empirically derived from ratings on approximately 1,000 subjects,
      and the items resolve onto five subscales: (I). Irritability (15 items), (II) Lethargy/Social
      Withdrawal (16 items), (III) Stereotypic Behavior (7 items), (IV) Hyperactivity (16 items),
      and (V) Inappropriate Speech (4 items). The primary caregiver will serve as the rater.

      Additional Information:

      Demographic Questionnaire: Parent will complete the ATN demographic questionnaire, which
      inquires about family make-up and education, medical history, etc.

      Supplemental Information: At all sites, clinicians will conduct clinical interviews and
      informal observations sufficient to gather enough information to inform DSM-IV and DSM-5
      criteria determination. Sites may also use supplemental information that is available to
      them. For example, prior evaluations may have been conducted. In addition, sites also may use
      a variety of additional questionnaires, such as the Social Communication Questionnaire (ref)
      or the Social Responsiveness Scale (SRS). Questionnaires or reports from a child's school are
      also frequently obtained as part of the assessment process. Such information can be used by
      the evaluation team to determine the final diagnosis.

      Diagnostic Determination:

      At the conclusion of the evaluation, the assessor (along with any other team members) will
      use the information obtained from the above sources to complete the DSM-IV checklist. If more
      than one clinician was involved in the assessment, a consensus will be obtained. After the
      DSM-IV checklist has been completed, the DSM-5 checklist will be completed using the same
      information (including the consensus scores on the DSM-IV checklist).

      DSM-IV Checklist: The DSM-IV checklist (APA, 2002) is a clinician-completed questionnaire
      that lists the X symptoms for autistic disorder. Each is scored as being "present/absent."
      Finally, the clinician notes which, if any, PDD diagnosis was made (based upon the results of
      the DSM-IV checklist).

      DSM-5 Checklist: The DSM-5 checklist is a clinician-completed questionnaire that lists the
      seven symptoms for autism spectrum disorder from DSM5 (APA 2013). Each is scored as being
      "present/absent." In addition, there is a column for noting if the symptom is currently
      present or was only reported in the past ("present by history"). Finally, the clinician notes
      if an ASD diagnosis was made (based upon the results of the DSM-5 checklist).

      Final Diagnosis:

      The following information regarding each subject's final diagnosis will be entered onto the
      Diagnostic Form:

      ADOS Results: Autism, Autism Spectrum, Nonspectrum

      DSM-IV Diagnosis: Autism, PDD NOS, Asperger's Disorder, Nonspectrum

      DSM-5 Diagnosis: ASD, Social Communication Disorder, Nonspectrum

      Consensus Diagnosis Old: Autism, PDD NOS, Asperger's, Nonspectrum

      Consensus Diagnosis New: Autism Spectrum Disorder (Level 1, 2 or 3); Nonspectrum

      Item-level and algorithim scores: Should be included in the database for the ADOS-2 and both
      DSM-IV and DSM-5 checklists.

      Additional Variables:

      The following information will also be noted:

        -  List of additional measures used to make the diagnostic decision (e.g., SRS School, SRS
           Home, SCQ, Vineland)

        -  If child is Nonspectrum, indicate other primary diagnoses (e.g., OCD, Anxiety Disorder,
           ADHD, RAD)

      Statistical Analysis

      Hypothesis 1: DSM-5 diagnostic criteria will have good specificity but poor sensitivity when
      comparing results with DSM-IV-TR ASD diagnostic criteria. A Chi-Square test will be used to
      compare the rate of ASD diagnosis (autistic disorder, PDD-NOS, Asperger's disorder) using
      DSM-IV-TR versus DSM-5 criteria. Based upon the DSM-IV-TR diagnosis (which will serve as the
      gold standard), both specificity and sensitivity for DSM-5 will be calculated. Sensitivity
      will be calculated as the proportion of individuals who meet DSM-IV-TR criteria for an ASD
      (including autistic disorder, PDD-NOS, and Asperger's disorder) who also meet DSM-IV criteria
      for an ASD (i.e., true positives). Specificity will be calculated as the proportion of
      individuals who do not meet DSM-IV-TR criteria who also do not meet DSM-5 criteria (i.e.,
      true negatives). Sensitivity and specificity will also be calculated for each of the three
      DSM-IV subtypes (autistic disorder, PDD NOS, and Asperger's disorder).

      Hypothesis 2: Lower IQ will be associated with greater DSM-IV/DSM-5 concordance. Concordance
      will be defined as agreement between DSM-IV and DSM-5 regarding the presence or absence of an
      ASD diagnosis; discordance will be defined as disagreement (either DSM-IV positive and DSM-5
      negative, or DSM-IV negative and DSM-5 positive). Logistic regression will be used to
      determine whether Full Scale IQ score predicts concordance (versus discordance).
    

Intervention name(s): DSM
Intervention type(s): Other
Intervention description(s): Comparing use of DSM-IV versus DSM-5 criteria for autism spectrum disorder
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All children ages 2-17 who are being evaluated for a possible diagnosis of autism spectrum
        disorder
      
Keywords: DSM Diagnosis