Att 4a_SEED 3 Eligibility Criteria

Attachment 4. a.

SEED Eligibility Criteria

The following criteria describe which children are eligible for SEED 3 and the justifications for these criteria:

• Child is born between January 2014 and 2017.

• Child is 24-68 months old at time of enrollment. This age range, was chosen in order to limit recall bias for events in pregnancy and early life as much as possible while still allowing diagnostic accuracy for ASD and is similar to SEED Phases 1 and 2.

• Child was born in and currently resides in the study catchment area. A child is determined to have been “born in” the study catchment area based on maternal residence at birth of the child. The defined cohort is to be ascertained from birth certificate data; current residence is required for ascertainment purposes and to allow for examinations and other in-person assessments of enrolled subjects.

• Child currently resides with the knowledgeable biologic mother. For the purposes of this study a knowledgeable biologic mother resides with and has consistently been caring for the child since the child was 6 months of age or younger (based on self-report). This criterion is necessary in order to collect accurate information on pregnancy and early life events that may be risk factors for the development of autism.

• Legal consent is obtainable from the biologic mother.

• The biologic mother is competent to communicate orally in English or Spanish. This limitation is necessary since the clinical study instruments to be administered are only available and validated in English and Spanish. Some sites may exclude Spanish-only speaking participants based on the percentage of Spanish-only speaking residents in the study catchment area and other site specific factors.

• The child is not identified by the mother as deaf or blind, or unable to walk independently. Children who are reported to be deaf or blind or unable to walk independently will be excluded since they would be unable to complete the standardized instruments administered during the developmental evaluation.

• Child is not a sibling of a previously enrolled SEED 1, SEED 2, or SEED 3 participant. This limitation is necessary to avoid multiple observations with duplicate family data in the main case-control analyses.

Children must meet all of the above criteria to be eligible to participate.