Despite significant advances in our understanding of the clinical features of autism spectrum disorders (ASD) and substantial progress in establishing ASD prevalence studies across multiple populations, for the most part the causes of ASD remain unexplained. The most significant advance related to etiology has been recognition of the strong genetic influence on ASD occurrence, although no specific genes have been identified. In the face of these considerable gaps in our understanding of the causes of and risk factors for ASDs, large population-based epidemiologic studies of ASD etiology are lacking. The proposed data collection is designed to address this critical need. The Study to Explore Early Development (OMB 0920-0741) was initiated following OMB approval in October 2007. As planned, it is expected that SEED enrollment will continue through 2010 and data collection will continue until 2012. The overall purpose of this study is to identify risk factors and potential causes associated with ASD. This will be accomplished through the investigation of six high priority research domains concerning potential etiologic factors. Study investigators selected the domains after an extensive review of the literature. Investigators designated each of the domains as high priority based on the strength of their reported associations with ASD and recognition of the outstanding research gaps in each area, balanced by appropriateness of the SEED design and feasibility of obtaining relevant data. The specific research goals of each domain are as follows: investigation of the ASD phenotype, infection and immune function, reproductive and hormonal features, gastrointestinal features, sociodemographic features, and genetic features.
The overall burden per participant remains unchanged from the initial OMB-PRA approval. Minor revisions to the forms consist of classification of some questionnaire instructions and clarifying the text for specific questions to make the instruments easier to complete and further improve data quality. While the burden hours per participant remain unchanged, the total burden hours for the next 3-year collection period are different. This is due to an expansion of the eligible study participant birth date range from September 1, 2003 - August 31, 2005 to September 1, 2003 - August 31, 2006. We have calculated the burden estimate to accommodate this change.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form No number SEED - Follow-Up Telephone Calls
_SEED_Supp_Statement_B.doc
Appendix_Y_Participant_Newsletter_example.pdf
Appendix_Z_Detailed_Breakdown_BurdenHOURSand COSTS_margins_ok.docx
SEED_ Informed Consent Forms for Control Parents