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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02296502
Enrollment
439
Registered
2014-11-20
Start date
2014-11-30
Completion date
2016-11-30
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

DSM Diagnosis

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. 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).

Interventions

OTHERDSM

Comparing use of DSM-IV versus DSM-5 criteria for autism spectrum disorder

Sponsors

University of Missouri-Columbia
CollaboratorOTHER
Children's Hospital Los Angeles
CollaboratorOTHER
Nationwide Children's Hospital
CollaboratorOTHER
Children's Hospital Medical Center, Cincinnati
CollaboratorOTHER
Vanderbilt University
CollaboratorOTHER
University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* \<2 years old \>17 years old

Design outcomes

Primary

MeasureTime frameDescription
Clinical Features of Concordant vs Discordant GroupsOne dayClinical 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 CriteriadaySensitivity 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
248
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
1
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
30
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. DSM: Comparing use of DSM-IV versus DSM-5 criteria for autism spectrum disorder
160
Total439

Baseline characteristics

CharacteristicAutism Spectrum Disorder (DSM IV & 5)Autism Spectrum Disorder (DSM 5 Only)Autism Spectrum Disorder (DSM IV Only)Non-Autism Spectrum DisorderTotal
Age, Continuous6.43 years
STANDARD_DEVIATION 4
12.66 years
STANDARD_DEVIATION 0
8.85 years
STANDARD_DEVIATION 3.89
7.75 years
STANDARD_DEVIATION 4.28
7.1 years
STANDARD_DEVIATION 4.2
Ethnicity (NIH/OMB)
Hispanic or Latino
20 Participants0 Participants2 Participants11 Participants33 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
212 Participants1 Participants25 Participants136 Participants374 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
16 Participants0 Participants3 Participants13 Participants32 Participants
Household Income
≥ $100,000
28 Participants0 Participants11 Participants18 Participants57 Participants
Household Income
≤ $24,999
57 Participants0 Participants3 Participants40 Participants100 Participants
Household Income
$25,000 - 49,999
55 Participants1 Participants6 Participants34 Participants96 Participants
Household Income
$50,000 - 74,999
42 Participants0 Participants2 Participants17 Participants61 Participants
Household Income
$75,000 - 99,999
30 Participants0 Participants2 Participants17 Participants49 Participants
Household Income
Unable to collect
36 Participants0 Participants6 Participants34 Participants76 Participants
Parental Education
Bachelor's Degree
43 Participants0 Participants8 Participants29 Participants80 Participants
Parental Education
< High school
10 Participants0 Participants2 Participants8 Participants20 Participants
Parental Education
High school
55 Participants0 Participants4 Participants47 Participants106 Participants
Parental Education
Postgraduate
38 Participants0 Participants7 Participants20 Participants65 Participants
Parental Education
Some College
83 Participants1 Participants8 Participants47 Participants139 Participants
Parental Education
Unable to collect
19 Participants0 Participants1 Participants9 Participants29 Participants
Race/Ethnicity, Customized
Race
Asian
3 Participants0 Participants0 Participants2 Participants5 Participants
Race/Ethnicity, Customized
Race
Black or African American
26 Participants0 Participants1 Participants9 Participants36 Participants
Race/Ethnicity, Customized
Race
Caucasian/White
188 Participants1 Participants26 Participants126 Participants341 Participants
Race/Ethnicity, Customized
Race
Other
18 Participants0 Participants2 Participants12 Participants32 Participants
Race/Ethnicity, Customized
Race
Unknown/Unable to collect
13 Participants0 Participants1 Participants11 Participants25 Participants
Sex: Female, Male
Female
45 Participants0 Participants12 Participants34 Participants91 Participants
Sex: Female, Male
Male
203 Participants1 Participants18 Participants126 Participants348 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 2480 / 10 / 300 / 160
other
Total, other adverse events
0 / 2480 / 10 / 300 / 160
serious
Total, serious adverse events
0 / 2480 / 10 / 300 / 160

Outcome results

Primary

Clinical Features of Concordant vs Discordant Groups

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

Time frame: One day

ArmMeasureGroupValue (MEAN)Dispersion
Both DSM-IV and DSM-5Clinical Features of Concordant vs Discordant GroupsFull Scale IQ76.18 units on a scaleStandard Deviation 22.52
Both DSM-IV and DSM-5Clinical Features of Concordant vs Discordant GroupsABC Irritability14.96 units on a scaleStandard Deviation 10.01
Both DSM-IV and DSM-5Clinical Features of Concordant vs Discordant GroupsABC Social Withdrawal12.83 units on a scaleStandard Deviation 8.72
Both DSM-IV and DSM-5Clinical Features of Concordant vs Discordant GroupsABC Stereotypic Behavior5.85 units on a scaleStandard Deviation 4.87
Both DSM-IV and DSM-5Clinical Features of Concordant vs Discordant GroupsABC Hyperactivity/Noncompliance19.86 units on a scaleStandard Deviation 11.86
Both DSM-IV and DSM-5Clinical Features of Concordant vs Discordant GroupsABC Inappropriate Speech3.64 units on a scaleStandard Deviation 3.11
Both DSM-IV and DSM-5Clinical Features of Concordant vs Discordant GroupsCBCL Externalizing Problems T-Score61.69 units on a scaleStandard Deviation 11.67
Both DSM-IV and DSM-5Clinical Features of Concordant vs Discordant GroupsCBCL Internalizing Problems T-Score65.33 units on a scaleStandard Deviation 9.44
DSM-IV But Not DSM-5Clinical Features of Concordant vs Discordant GroupsCBCL Internalizing Problems T-Score62.20 units on a scaleStandard Deviation 11.15
DSM-IV But Not DSM-5Clinical Features of Concordant vs Discordant GroupsFull Scale IQ89.85 units on a scaleStandard Deviation 22.06
DSM-IV But Not DSM-5Clinical Features of Concordant vs Discordant GroupsABC Hyperactivity/Noncompliance17.79 units on a scaleStandard Deviation 12.54
DSM-IV But Not DSM-5Clinical Features of Concordant vs Discordant GroupsABC Irritability13.94 units on a scaleStandard Deviation 10.71
DSM-IV But Not DSM-5Clinical Features of Concordant vs Discordant GroupsCBCL Externalizing Problems T-Score61.57 units on a scaleStandard Deviation 12.69
DSM-IV But Not DSM-5Clinical Features of Concordant vs Discordant GroupsABC Social Withdrawal8.22 units on a scaleStandard Deviation 5.4
DSM-IV But Not DSM-5Clinical Features of Concordant vs Discordant GroupsABC Inappropriate Speech2.93 units on a scaleStandard Deviation 2.7
DSM-IV But Not DSM-5Clinical Features of Concordant vs Discordant GroupsABC Stereotypic Behavior3.85 units on a scaleStandard Deviation 3.19
Primary

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

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.

Time frame: day

ArmMeasureGroupValue (NUMBER)
Both DSM-IV and DSM-5Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV CriteriaSensitivity0.25 proportion of pts dx'd ASD w/DSM5
Both DSM-IV and DSM-5Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV CriteriaSpecificity0.41 proportion of pts dx'd ASD w/DSM5
DSM-IV But Not DSM-5Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV CriteriaSensitivity0.80 proportion of pts dx'd ASD w/DSM5
DSM-IV But Not DSM-5Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV CriteriaSpecificity0.45 proportion of pts dx'd ASD w/DSM5
Autistic DisorderSensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV CriteriaSensitivity0.97 proportion of pts dx'd ASD w/DSM5
Autistic DisorderSensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV CriteriaSpecificity0.87 proportion of pts dx'd ASD w/DSM5
ASD TotalSensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV CriteriaSpecificity0.99 proportion of pts dx'd ASD w/DSM5
ASD TotalSensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV CriteriaSensitivity0.89 proportion of pts dx'd ASD w/DSM5
TotalSensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV CriteriaSensitivity0.89 proportion of pts dx'd ASD w/DSM5
TotalSensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV CriteriaSpecificity0.99 proportion of pts dx'd ASD w/DSM5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026