NCT02296502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
439

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

March 11, 2019

Completed
Last Updated

March 11, 2019

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

November 18, 2014

Results QC Date

July 7, 2017

Last Update Submit

November 21, 2018

Conditions

Keywords

DSM Diagnosis

Outcome Measures

Primary Outcomes (2)

  • 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

    One day

  • 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.

    day

Study Arms (4)

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

Other: DSM

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

Other: DSM

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

Other: DSM

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.

Other: DSM

Interventions

DSMOTHER

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

Autism Spectrum Disorder (DSM 5 only)Autism Spectrum Disorder (DSM IV & 5)Autism Spectrum Disorder (DSM IV only)Non-Autism Spectrum Disorder

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All children ages 2-17 who are being evaluated for a possible diagnosis of autism spectrum disorder

You may qualify if:

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

You may not qualify if:

  • \<2 years old \>17 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

University of Missouri

Columbia, Missouri, 65201, United States

Location

Children's Hospital of Cincinnati

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43081, United States

Location

Vanderbilt University

Nashville, Tennessee, 37240, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Benjamin L Handen, PhD
Organization
University of Pittsburgh

Study Officials

  • Benjamin Handen, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professof of Psychiatry

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 20, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

March 11, 2019

Results First Posted

March 11, 2019

Record last verified: 2018-11

Locations