Autism Spectrum Disorders

July 8, 2021

New Cognoa app for diagnosing ASD approved by the FDA June 2, 2021.

FDA approves ASD diagnostic app

Note:   Potential users are advised to read the complete FDA notice as well as the publisher’s description  before using this tool.  A selection from the FDA text is copied and pasted below.  Users are reminded that the IDEA requires evaluators to use instruments that have demonstrated reliability and validity for the purpose for which they are being used.  We’ve not yet found a quick and easy way to translate the stats cited by the FDA into more traditional reliability and validity coefficients.  The end user is responsible for determining compliance with the IDEA and for being prepared to defend his or her choice in an adversarial proceeding.

Quotes from the FDA:

“The FDA reviewed the Cognoa ASD Diagnosis Aid through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The Cognoa ASD Diagnosis Aid is indicated as an aid in the diagnosis of ASD for patients 18 months through 5 years of age who are at risk of developmental delay based on concerns of a parent, caregiver, or health care provider. The device is not indicated for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process.”

This reviewer would conclude that the use of this tool will be most appropriate within the context of a more comprehensive evaluation also using a tool with documented reliability and validity such as the ADOS-2.

Critical reviews:

A critical review by Connor Hale, June 2, 2021.

Doubt, Confusion by Hannah Furfaro

The publisher reports the app should be available later in 2021.   The publisher’s description follows:

“The FDA has granted Cognoa marketing authorization of Cognoa’s autism diagnosis aid. Introducing Canvas Dx.

Cognoa expects to begin making Canvas Dx available in the U.S. later in 2021.

Reporting on this new development in autism diagnosis does not necessarily imply our endorsement.  Despite being labeled as a diagnostic tool, the publisher’s own description suggests that it would be more appropriately used as a screener by a qualified professional in a clinical setting.  

July 1, 2017  Autism Screening Tools

A number of schools use ASD screening instruments before investing in a full scale evaluation (usually using the ADOS).    Some of the screening instruments more commonly reported with publishers’ summaries and links are reported below.  Some of the scales below may also be available from a different publisher, sometimes at a lower cost.  Inclusion here does not imply endorsement. Links are embedded in the title  of each sceener.

Social Responsiveness Scale, Second Edition
Publisher:  Par Inc
Publisher’s Description

Completed in just 15 to 20 minutes, the SRS-2 identifies social impairment associated with autism spectrum disorder (ASD) and quantifies its severity. Sensitive enough to detect even subtle symptoms but specific enough to differentiate clinical groups, the SRS-2 can be used to monitor symptoms throughout the life span.

Features and benefits

• Allows you to assess social impairment in natural settings—teachers, parents, and others are asked to rate symptoms that they’ve noticed over time at home, in the classroom, or elsewhere. Raters evaluate symptoms using a quantitative scale representing a range of severity.
• In addition to a total score reflecting severity of social deficits in the autism spectrum, five treatment subscale scores are provided: Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behavior. Two subscales are considered DSM-5™-compatible: Scores on these subscales make it easy to compare your client’s symptoms to DSM-5diagnostic criteria for ASD.

Test structure

• Offers four forms with 65 items each: school-age (ages 4-18 years), preschool (ages 2.5-4.5 years), adult (ages 19 years and older), and adult self-report.
• The SRS-2 unlimited-use scoring program gives you a detailed report with useful descriptive information that can inform intervention.

Technical information

• Numerous independent studies demonstrate that the SRS-2 is unmatched in its ability to measure severity of social impairment in the mildest, and most common, forms of ASD—including social communication disorder, a new diagnosis included in the DSM-5.
• A multitude of independent, peer-reviewed studies conducted in schools and clinics throughout the world involving diverse populations and diagnostic groups show that the SRS-2 discriminates both within the autism spectrum and between ASD and other disorders, making the test highly useful for differential diagnosis. When results indicate that autism is not present, they often point to other conditions in which social impairment plays a role.

Autism Spectrum Rating Scale
Publisher:  Pearson
Publisher’s Description:

The first nationally standardized, norm-referenced ASD Rating Scale.

The ASRS provides the first nationally standardized, norm-referenced ASD Rating Scale. This multi-informant measure is designed to help you identify symptoms, behaviors, and associated features of Autism Spectrum Disorders (ASDs) in children and adolescents ages 2 to 18.

Use the ASRS to help:

• Support the diagnostic process
• Guide the development of intervention and treatment strategies
• Monitor responses to intervention and its effectiveness
• Behavioral Rigidity
• Sensory Sensitivity
• Attention/Self-Regulation (Full form for ages 2–5)
• Attention (Full form for ages 6–18)
• Social/Emotional Reciprocity

Administration

Using a five-point Likert rating scale, parents and teachers are asked to evaluate how often they observe specific behaviors in the child or adolescent. The full form contains 70 items for ages 2–5 and 71 items for ages 6–18. The short form, designed for ages2–18, contains 15 items.

Key areas measured:

• Social/Communication
• Unusual Behaviors
• Self-Regulation (Full form for ages 6–18)
• Peer Socialization
• Adult Socialization
• Atypical Language
• Stereotypy

Features & Benefits

• Items help assess DSM–IV–TR® symptom criteria for ASDs.
• Easy administration, scoring, and result interpretation.
• Excellent reliability and validity.
• Short form can be used for screening or treatment monitoring.

Autism Diagnostic Interview, Revised
Publisher:  WPS Publishing
Publisher’s Description:

BY MICHAEL RUTTER, MD, FRS, ANN LECOUTEUR, MBBS, AND CATHERINE LORD, PHD

Used in research for decades, this comprehensive interview provides a thorough assessment of individuals suspected of having autism or other autism spectrum disorders. The ADI-R has proven highly useful for formal diagnosis as well as treatment and educational planning.

To administer the ADI-R, an experienced clinical interviewer questions a parent or caretaker who is familiar with the developmental history and current behavior of the individual being evaluated. The interview can be used to assess both children and adults, as long as their mental age is above 2 years, 0 months.

Evaluate Three Functional Domains

Composed of 93 items, the ADI-R focuses on three functional domains:

• Language/Communication
• Reciprocal Social Interactions
• Restricted, Repetitive, and Stereotyped Behaviors and Interests

Following highly standardized procedures, the interviewer records and codes the informant’s responses. Interview questions cover eight content areas:

• The subject’s background, including family, education, previous diagnoses, and medications
• Overview of the subject’s behavior
• Early development and developmental milestones
• Language acquisition and loss of language or other skills
• Current functioning in regard to language and communication
• Social development and play
• Interests and behaviors
• Clinically relevant behaviors, such as aggression, self-injury, and possible epileptic features

Use One Convenient Form to Score Any ADI-R Algorithm

Typically, administration and scoring require from 1½ to 2½ hours.

Results can now be scored and interpreted using a single convenient form rather than the five forms previously required. The Comprehensive Algorithm Form (W-382E) allows you to calculate and interpret any one of five age-specific ADI-R algorithms (two Diagnostic Algorithms based on developmental history and used for formal diagnosis, and three Current Behavior Algorithms focusing on present functioning and used for treatment and educational planning). The algorithms themselves have not changed; the revised form simply replaces the five forms previously needed to calculate the algorithms.

Support Diagnosis or Determine Clinical Needs

Because the ADI-R is an interview rather than a test, and because it focuses on behaviors that are rare in unaffected individuals, it provides categorical results rather than scales or norms. Results can be used to support a diagnosis of autism or to determine the clinical needs of various groups in which a high rate of autism spectrum disorders might be expected (e.g., individuals with severe language impairments or certain medical conditions, children with congenital blindness, and youngsters suffering from institutional deprivation). The ADI-R has proven very effective in differentiating autism from other developmental disorders and in assessing syndrome boundaries, identifying new subgroups, and quantifying autistic symptomatology. Extensive use of the ADI-R in the international research community has provided strong evidence of the reliability and validity of its categorical results.

Master the ADI-R with DVD Training

It is strongly recommended that you obtain training before administering the ADI-R. The ADI-R DVD Training Package offered by WPS gives you the opportunity to learn administration procedures and practice accurate coding. (See WPS Product No. W-382DVT in the U.S. and Canada; W-382DVP elsewhere.)

The ADI-R DVD Training Package consists of eight DVDs (with a total running time of 16 hours), an accompanying Guidebook, nine Interview Booklets, and three Comprehensive Algorithm Forms. The DVDs allow you to observe expert interviewers as they administer the ADI-R to parents. The Guidebook discusses each case featured on the DVDs, clarifying coding and scoring decisions. (NOTE: Study of the DVDs and Guidebook is required. While the DVDs may be viewed by multiple professionals, each trainee must individually review the Guidebook and complete the Interview Booklets and Algorithm Forms.)

When you have finished the DVD Training Package, you can receive 18 continuing education credits by purchasing and successfully completing the ADI-R Continuing Education (CE) Questionnaire and Evaluation Form (W-382CE).

If you plan to use the ADI-R in formal research, you may require additional training provided by the test authors and their colleagues. Contact WPS Customer Service for information about training for research applications.

Score All ADI-R Algorithms With an Unlimited-Use CD

The ADI-R unlimited-use CD allows you to score all ADI-R algorithms. Use the standard paper-and-pencil administration (W-382A) and enter responses into the program for rapid results.

Gilliam Autism Rating Scale, Third Edition
Publisher:  Pro-Ed Inc
Publisher’s Description:

Based on DSM-5 Definition of Autism Spectrum Disorder

Ages: 3 through 22
Testing Time: 5 to 10 minutes
Administration: Individual

The Gilliam Autism Rating Scale, now in its third edition, is one of the most widely used instruments for the assessment of Autism Spectrum Disorder in the world. The GARS-3 assists teachers, parents, and clinicians in identifying autism in individuals and estimating its severity. Items on the GARS-3 are based on the 2013 diagnostic criteria for autism spectrum disorder adopted by the APA and published in the Diagnostic and Statistical Manual of Mental Disorders–Fifth Edition (DSM-5). The GARS-3 yields standard scores, percentile ranks, severity level, and probability of Autism.

The instrument consists of 56 clearly stated items describing the characteristic behaviors of persons with autism. The items are grouped into six subscales: Restrictive/Repetitive Behaviors, Social Interaction, Social Communication, Emotional Responses, Cognitive Style, and Maladaptive Speech.

New Features of the GARS-3

• Items and subscales reflect DSM-5 diagnostic criteria for Autism Spectrum Disorder.
• Forty-four new items were added to the GARS-3.
• All six subscales have been empirically determined to be valid and sensitive for identification of children with ASD.
• Normative data (N = 1,859) were collected in 2010 and 2011.
• Demographic characteristics of the normative sample are keyed to those reported by U.S. Bureau of the Census, 2011.
• An interpretation guide in the Examiner’s Manual allows the examiner an easy and efficient method for assessing the probability of autism spectrum disorder and the severity of the disorder.

Reliability and Validity

• Internal consistency (content sampling) reliability coefficients for the subscales exceed .85 and the Autism Indexes exceed .93.
• Test-retest (time sampling) reliability coefficients exceed .80 for subscales and .90 for the Autism Indexes.
• Interrater reliability intraclass coefficients exceed .80 and .84 for the Autism Indexes.
• Correlations of the GARS-3 scores with those of other well-known diagnostic tests for autism are large or very large in magnitude.
• All new validity studies show that the test results are valid for a wide variety of subgroups, as well as for the general population.
• Binary classification studies indicate that the GARS-3 is able to accurately discriminate children with autism spectrum disorder from children without autism (i.e., sensitivity = .97, specificity = .97, ROC/AUC = .93.
• Confirmatory and exploratory factor analyses demonstrate the theoretical and empirical validity of the subscales.
• Other validity evidence is provided in the manual.

Complete GARS-3 Kit Includes: Examiner’s Manual, 50 Summary/Response Forms, and the Instructional Objectives manual, all in a sturdy storage box. (©2014).

Childhood Autism Rating Scale, Second Edition
Publisher: WPS Publishing
Publisher’s Description:

BY ERIC SCHOPLER, PHD, MARY E. VAN BOURGONDIEN, PHD, GLENNA JANETTE WELLMAN, PHD, AND STEVEN R. LOVE, PHD

Since its original publication, the CARS has become one of the most widely used and empirically validated autism assessments. It has proven especially effective in discriminating between children with autism and those with severe cognitive deficits, and in distinguishing mild-to-moderate from severe autism.

The revised second edition expands the test’s clinical value, making it more responsive to individuals on the “high-functioning” end of the autism spectrum—those with average or higher IQ scores, better verbal skills, and more subtle social and behavioral deficits. While retaining the simplicity, brevity, and clarity of the original test, the CARS2 adds forms and features that help you integrate diagnostic information, determine functional capabilities, provide feedback to parents, and design targeted intervention.

The CARS2 includes three forms:

Standard Version Rating Booklet (CARS2-ST)

Equivalent to the original CARS; for use with individuals younger than 6 years of age and those with communication difficulties or below-average estimated IQs

High-Functioning Version Rating Booklet (CARS2-HF)

An alternative for assessing verbally fluent individuals, 6 years of age and older, with IQ scores above 80

Questionnaire for Parents or Caregivers (CARS2-QPC)

An unscored scale that gathers information for use in making CARS2-ST and CARS2-HF ratings

The Standard and High-Functioning Forms

The CARS2-ST and CARS2-HF each include 15 items addressing the following functional areas:

• Relating to People
• Imitation (ST); Social–Emotional Understanding (HF)
• Emotional Response (ST); Emotional Expression and Regulation of Emotions (HF)
• Body Use
• Object Use (ST); Object Use in Play (HF)
• Adaptation to Change (ST); Adaptation to Change/Restricted Interests (HF)
• Visual Response
• Listening Response
• Taste, Smell, and Touch Response and Use
• Fear or Nervousness (ST); Fear or Anxiety (HF)
• Verbal Communication
• Nonverbal Communication
• Activity Level (ST); Thinking/Cognitive Integration Skills (HF)
• Level and Consistency of Intellectual Response
• General Impressions

Items on the Standard form duplicate those on the original CARS, while items on the High-Functioning form have been modified to reflect current research on the characteristics of people with high-functioning autism or Asperger’s Syndrome.

The clinician rates the individual on each item, using a 4-point response scale. Ratings are based not only on frequency of the behavior in question, but also on its intensity,peculiarity, and duration. While this more nuanced approach gives you greater flexibility in integrating diagnostic information, it still yields quantitative results.

The Rating Booklets for both the Standard and High-Functioning versions are particularly convenient. They include space for clinical note-taking and documentation. They briefly describe each area rated, providing a reminder of rating criteria and a framework for explaining results to parents. And they list cutoff values so that you can see at a glance whether further evaluation is warranted.

Rating values for all items are summed to produce a Total Raw Score. Each form includes a graph that allows you to quickly convert the Total Raw Score to a standard score or percentile rank (based on a clinical sample of 1,034 individuals with autism spectrum disorders). The Manual provides guidelines for score interpretation, suggestions for intervention, and case examples.

The Questionnaire for Parents or Caregivers

The CARS2-QPC is an unscored form completed by the parent or caregiver of the individual being assessed. Its purpose is to give the clinician more information on which to base CARS2-ST or CARS2-HF ratings. Often the questionnaire serves as the framework for a follow-up interview, during which the clinician can clarify and interpret the responses provided by the parent or caregiver.

The areas covered by the CARS2-QPC include the individual’s early development; social, emotional, and communication skills; repetitive behaviors; play and routines; and unusual sensory interests.

The Best Way to Inform and Support Diagnosis

The CARS2 is extremely useful in identifying symptoms of autism.

• It covers the entire autism spectrum, as defined by empirical research.
• It is based on decades of use with thousands of referred individuals.
• It assesses virtually all ages and functional levels.
• It provides concise, objective, and quantifiable ratings based on direct behavioral observation.
• Scores show a consistent, strong, positive, and specific relationship with autism diagnosis.
• Ratings are reliable across time, settings, sources of information, and raters.

With a new form for higher functioning individuals, a structured way to gather caregiver information, and guidelines linking scores to intervention, the CARS2 remains one of the best autism assessments available.

Litigation on Autism

According to a published review of court decisions regarding FAPE and the LRE, almost a third of those cases involved disputes over services to children with autism.  Putting it another way, when comparing the actual incidence of children identified with autism to the incidence of litigation about those children,  schools were about ten times more likely to find themselves in litigation over a child with autism than over children with other disabilities.
Zirkel Article on Autism Litigation 2012

Perry Zirkel also wrote a more general article on “Legal Issues Related to Autism” in 2008
Zirkel (2008): Legal Issues Related to Autism

Zirkel Article on Autism Litigation 2011

Article about Zirkel’s Study 2011 (Web page)

There are a number of websites on the Internet that provide a sampling of those cases.   A sampling of those links (which provide a sampling of cases) are provided below.

Wrightslaw on Autism

Many  excellent resources cited on the Internet and even on our links page have not been updated to reflect the changes in the DSM 5.  The following article provides both the revised criteria and a discussion of their application.    While the language is not as parent friendly as some handouts in the past,  it is at least up to date .

See:   DSM-5 (ASD.Guidelines) Feb2013

On July 7, 2014 the Center for Medicare and Medicaid Services (CMS) in the United States Department of Health and Human Services  issued a Clarification of Services to  Children with Autism that expanded covered services to include (among other things) Applied Behavioral Analysis (ABA).

Federal Medicaid Policy Guidance

It is too early for us to be trying to  interpret the potential impact of these changes, but a number of national and state agencies have already weighed in with their opinions.   A representative sample follows.   As more definitive analyses become available, they will be added below.

California Healthline Comments on Medicaid Obligations

ASHA: CMS Issues Clarification

For additional information on our Sped Resources page, click on Autism Links

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