05-14681. Proposed Data Collections Submitted for Public Comment and Recommendations

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Proposed Project

Validating Autism Surveillance Methodology in Metropolitan Atlanta Developmental Disabilities Surveillance Program (MADDSP)—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

MADDSP was established in 1991 as an ongoing active surveillance system for select developmental disabilities (mental retardation, cerebral palsy, vision impairment, and hearing loss) in 3 to 10 year old children. In 1996, autism spectrum disorders (ASD) was added to MADDSP due to growing concern about the prevalence of the condition. MADDSP defines ASD as a constellation of social, communicative, and behavioral impairments consistent with the DSM-IV-TR diagnostic criteria for Autistic Disorder, Asperger's Disorder, and Pervasive Developmental Disorders not otherwise specified.

MADDSP relies on an extensive review of records to identify children with an ASD. Potential case records are identified from multiple sources which are likely to maintain evaluation or treatment records for children with ASD. Pertinent ICD-9, DSM-IV codes and predetermined behavioral descriptions are used to trigger records for abstraction. Clinical experts then review the abstracted data and determine case status based on a behavioral coding scheme that is in accordance with the DSM-IV-TR definition for Pervasive Developmental Disorders.

This record review methodology for ASD surveillance has been executed and is being used; however, the method is not currently validated by a clinical sample which is considered the gold standard for identifying ASD. For this reason, it is important to validate surveillance methods in a clinical sample in order to determine whether current surveillance methodology accurately captures prevalence estimates for this developmental outcome. The sensitivity and specificity of MADDSP will be measured using judgments from the clinical exam as the gold standard. The results from this study will provide important implications for how ASD surveillance is maintained.

Primary caregivers of children already identified through surveillance methods will be contacted, informed of the study, and asked to participate through telephone contact. Clinic visits will be scheduled for all children whose primary caregiver agrees to take part in the study and who signs a written informed consent; child assent will be obtained at the time of the clinic visit. Data collection methods will consist of: (1) Parental questionnaires, which will focus on questions about their child's behavior and developmental history; and, (2) a developmental evaluation for the child participant, which includes a play based assessment specific to ASD and a measure of cognitive development. There is no cost to respondents other than their time. The total estimated annualized burden hours are 646.

Estimated Annualized Burden Table

Survey instruments	Number of respondents	Number of responses per respondent	Avg. burden per response (in hours)
Telephone Contact	500	1	10/60
Parental Interviews and Questionnaires	125	1*2.5
Developmental Evaluation of the Child	125	1	2
* One response per hour for an estimated 2.5 hours of clinic time; estimation of clinic time takes into consideration that parents and children will be encouraged to complete assessment simultaneously and that additional clinic time may be required due to individual differences.

Dated: July 20, 2005.

Betsey Dunaway,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.