Trial Outcomes & Findings for Comparison of DSM-IV-TR and DSM-5 for ASD (NCT NCT02296502)
NCT ID: NCT02296502
Last Updated: 2019-03-11
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
439 participants
Primary outcome timeframe
One day
Results posted on
2019-03-11
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
248
|
1
|
30
|
160
|
|
Overall Study
COMPLETED
|
248
|
1
|
30
|
160
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of DSM-IV-TR and DSM-5 for ASD
Baseline characteristics by cohort
| Measure |
Autism Spectrum Disorder (DSM IV & 5)
n=248 Participants
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
|
Autism Spectrum Disorder (DSM 5 Only)
n=1 Participants
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
|
Autism Spectrum Disorder (DSM IV Only)
n=30 Participants
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
|
Non-Autism Spectrum Disorder
n=160 Participants
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
|
Total
n=439 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
6.43 years
STANDARD_DEVIATION 4.00 • n=5 Participants
|
12.66 years
STANDARD_DEVIATION 0 • n=7 Participants
|
8.85 years
STANDARD_DEVIATION 3.89 • n=5 Participants
|
7.75 years
STANDARD_DEVIATION 4.28 • n=4 Participants
|
7.1 years
STANDARD_DEVIATION 4.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
203 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
348 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
212 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
374 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
26 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian/White
|
188 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
341 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
18 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown/Unable to collect
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Parental Education
< High school
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Parental Education
High school
|
55 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Parental Education
Some College
|
83 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
139 Participants
n=21 Participants
|
|
Parental Education
Bachelor's Degree
|
43 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Parental Education
Postgraduate
|
38 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Parental Education
Unable to collect
|
19 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Household Income
≤ $24,999
|
57 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Household Income
$25,000 - 49,999
|
55 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Household Income
$50,000 - 74,999
|
42 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Household Income
$75,000 - 99,999
|
30 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Household Income
≥ $100,000
|
28 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Household Income
Unable to collect
|
36 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: One 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
Outcome measures
| Measure |
Asperger's
n=30 Participants
Diagnosed Asperger's
|
Autistic Disorder
Diagnosed Autistic Disorder
|
ASD Total
Diagnosed with PDD-NOS, Asperger's, or Autistic Disorder.
|
Total
Total including not diagnosed
|
Both DSM-IV and DSM-5
n=248 Participants
Diagnosed with both DSM-IV and DSM-5 (concordant)
|
|---|---|---|---|---|---|
|
Clinical Features of Concordant vs Discordant Groups
Full Scale IQ
|
89.85 units on a scale
Standard Deviation 22.06
|
—
|
—
|
—
|
76.18 units on a scale
Standard Deviation 22.52
|
|
Clinical Features of Concordant vs Discordant Groups
ABC Irritability
|
13.94 units on a scale
Standard Deviation 10.71
|
—
|
—
|
—
|
14.96 units on a scale
Standard Deviation 10.01
|
|
Clinical Features of Concordant vs Discordant Groups
ABC Social Withdrawal
|
8.22 units on a scale
Standard Deviation 5.40
|
—
|
—
|
—
|
12.83 units on a scale
Standard Deviation 8.72
|
|
Clinical Features of Concordant vs Discordant Groups
ABC Stereotypic Behavior
|
3.85 units on a scale
Standard Deviation 3.19
|
—
|
—
|
—
|
5.85 units on a scale
Standard Deviation 4.87
|
|
Clinical Features of Concordant vs Discordant Groups
ABC Hyperactivity/Noncompliance
|
17.79 units on a scale
Standard Deviation 12.54
|
—
|
—
|
—
|
19.86 units on a scale
Standard Deviation 11.86
|
|
Clinical Features of Concordant vs Discordant Groups
ABC Inappropriate Speech
|
2.93 units on a scale
Standard Deviation 2.70
|
—
|
—
|
—
|
3.64 units on a scale
Standard Deviation 3.11
|
|
Clinical Features of Concordant vs Discordant Groups
CBCL Externalizing Problems T-Score
|
61.57 units on a scale
Standard Deviation 12.69
|
—
|
—
|
—
|
61.69 units on a scale
Standard Deviation 11.67
|
|
Clinical Features of Concordant vs Discordant Groups
CBCL Internalizing Problems T-Score
|
62.20 units on a scale
Standard Deviation 11.15
|
—
|
—
|
—
|
65.33 units on a scale
Standard Deviation 9.44
|
PRIMARY outcome
Timeframe: daySensitivity 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.
Outcome measures
| Measure |
Asperger's
n=25 Participants
Diagnosed Asperger's
|
Autistic Disorder
n=229 Participants
Diagnosed Autistic Disorder
|
ASD Total
n=278 Participants
Diagnosed with PDD-NOS, Asperger's, or Autistic Disorder.
|
Total
n=439 Participants
Total including not diagnosed
|
Both DSM-IV and DSM-5
n=24 Participants
Diagnosed with both DSM-IV and DSM-5 (concordant)
|
|---|---|---|---|---|---|
|
Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV Criteria
Sensitivity
|
0.80 proportion of pts dx'd ASD w/DSM5
|
0.97 proportion of pts dx'd ASD w/DSM5
|
0.89 proportion of pts dx'd ASD w/DSM5
|
0.89 proportion of pts dx'd ASD w/DSM5
|
0.25 proportion of pts dx'd ASD w/DSM5
|
|
Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV Criteria
Specificity
|
0.45 proportion of pts dx'd ASD w/DSM5
|
0.87 proportion of pts dx'd ASD w/DSM5
|
0.99 proportion of pts dx'd ASD w/DSM5
|
0.99 proportion of pts dx'd ASD w/DSM5
|
0.41 proportion of pts dx'd ASD w/DSM5
|
Adverse Events
Total SubjectsAutism Spectrum Disorder (DSM IV & 5)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Autism Spectrum Disorder (DSM 5 Only)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Autism Spectrum Disorder (DSM IV Only)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Autism Spectrum Disorder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place