The Study to Explore Early Development (SEED) - Phase 3 (Modified for COVID-19 Impact Assessment)

OMB 0920-1171

SEED is a multi-state case-control study designed to investigate risk factors for Autism Spectrum Disorders (ASDs) and the health and behavioral characteristics of children with ADS. SEED is specifically designed focused on preconception, prenatal, perinatal and early postnatal risk factors with primary emphasis on genetic, infectious, immunological, hormonal, and obstetric risk factors. Due to COVID-19, remote administration and feedback is being proposed in this change request.

The latest form for The Study to Explore Early Development (SEED) - Phase 3 (Modified for COVID-19 Impact Assessment) expires 2021-12-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 0920-21CS Vineland Adaptive Behavior Scales (for Covid-19 Impact Assessment) Form
Form 0920-21CS Covid-19 Impact Survey Form and Instruction
Form 0920-21CS Child Behavior Checklist (for Covid-19 Impact Assessment) Form and Instruction
Appendix C.1s_COV-IMP_Spanish CBCL_1-5yrs_pages 2-4.pdf Supplementary Document
Appendix C.1_COV-IMP_CBCL_1-5yrs.pdf Supplementary Document
OMB0920_1171 NonSubstantive Change_Spanish_1-20-21_final.docx Supplementary Document
OMB0920_1171 NonSubstantive Change Request Memo_11022020.docx Justification for No Material/Nonsubstantive Change
ITEM #2 Appendix B_COV-IMP_Power Calculations.docx Supplementary Document
ITEM #1 Appendix A_COV-IMP_Surveys with prior COVID content.docx Supplementary Document
ITEM #7 Appendix A.1_COV-IMP_ Invitation letter.docx Supplementary Document
OMB0920_1171 NonSubstantive Change Request August 24 2020.docx Justification for No Material/Nonsubstantive Change
Att 1 SEED 3 PROTOCOL_amendment #6_7-21-20.docx Supplementary Document
Att 21.d. Follow-up Call Items Checklist SEED 3_3-7-17.docx Supplementary Document
Att 19.h. Invitation E-mail Notice SEED 3_3-7-17.docx Supplementary Document
Attachment 19.h. Invitation E-mail Notice SEED 3.docx Supplementary Document
Attachment 25. References.docx Supplementary Document
Attachment 23.f. Age Out Letter_SEED 3.doc Supplementary Document
Attachment 23.e. Thank you or general Greeting Card_SEED 3.docx Supplementary Document
Attachment 23.d. ThankYouLetter_DD Completion Letter _SEED 3.doc Supplementary Document
Attachment 23.c. ThankYouLetter ASD POP_SEED 3.doc Supplementary Document
Attachment 23.b. ThankYou_Open-Ended Refusal Letter_SEED 3.doc Supplementary Document
Attachment 23.a. Parental Feedback Letter SEED3.docx Supplementary Document
Attachment 22. Passive Refusal Letter SEED 3.doc Supplementary Document
Attachment 15.d. Clinic Visit Prep Guide POP SEED 3_revised.docx Supplementary Document
Attachment 15.c. Clinic Visit Prep Guide ASD SEED 3_revised.doc Supplementary Document
Attachment 15.b. Picture Story Book SEED 3.docx Supplementary Document
Attachment 15.a. Frequently Asked Questions about Biologic Sampling SEED 3.doc Supplementary Document
Attachment 14. Review Panel for SEED 2015.docx Supplementary Document
Attachment 13. List of SEED 2 PIs.docx Supplementary Document
Att 19 - IRB Approval.doc Supplementary Document
Attachment 4.b. ICD DSM Code Spec ED Lists SEED 3.xls Supplementary Document
Attachment 4.a. SEED_3 Eligibility Criteria_12sept2016.docx Supplementary Document
Attachment 3 Site Specific Ascertainment SEED 3_9-16-16.docx Supplementary Document
Att 9a 60-Day FRN.pdf Supplementary Document
Attachment 1.c. - Children's Health ACT SEED 3.doc Supplementary Document
Attachment 1.b. - Combating Autism Act of 2006.pdf Supplementary Document
Attachment 1.a. - Public Health Service Act.pdf Supplementary Document
SS B_SEED Phase 3 revised 8-1-2019.docx Supporting Statement B
SS A_SEED Phase 3 revised 8-8-2019.docx Supporting Statement A
Invitation to Participate in the Covid-19 Impact Assessment Other-Invitation Letter
Vineland Adaptive Behavior Scales (for Covid-19 Impact Assessment) Form
Covid-19 Impact Survey Form and Instruction
Child Behavior Checklist (for Covid-19 Impact Assessment) Form and Instruction
Follow-up Call 2 Other-WORD
Self Administered Forms Other-WORD
Maternal Interview Call Other-WORD
DD - POST-ENROLLMENT F/U Phone Call Script Other-WORD
Enrollment Packet (DD) Other-WORD
Invitation Call Script Other-WORD
DD- PRE-ENROLLMENT Invitation Packet/Response Card (Mother) Other-WORD
Clinic/Home Visit - Developmental Assessment (Child) Other-WORD
Clinc/Home Visit - Saliva Collection (optional) Father Instruction
Clicnic/Home Visit - Developmental Assessment (Mother) Other-WORD
Followup Call 2 Other-WORD
Self-Administered Forms (Mother) Other-WORD
Maternal Interview Call Other-WORD
POP - POST ENROLLMENT_F/U Phone Call Script and Pregnancy Ref Form (Mother) Other-WORD
ENROLLMENT Packet (Mother) Instruction
Invitation Call Script and SCQ (Mother) Other-WORD
POP - PRE-ENROLLMENT Invitation Packet/Response Card (Mother) Other-WORD
Clinic / Home Visit -Development Assessment (Child) Other-WORD
Clinic / Home Vist -- Saliva Collection (Father) Other-WORD
Clinic / Home Visit - Saliva Collection (Mother) Instruction
Follow-up Call 2 (Mother) POP Other-WORD
Self Administered Forms (Mother) Other-WORD
Maternal Interview (Mother) Other-WORD
ASD - POST ENROLLMENT _F/U Phone Call / Pregnancy Ref Form- (Mother) Other-WORD
Enrollment Packet - ASD (Mother) Other-WORD
ASD - ENROLLMENT-Invitation Call Script and SCQ (Mother) Other-WORD
ASD - PRE-ENROLLMENT_Invitation Packet/Response Card (Mother) Other-WORD

All Historical Document Collections

202102-0920-008 Approved without change	No material or nonsubstantive change to a currently approved collection	2021-02-18
202012-0920-003 Approved with change	No material or nonsubstantive change to a currently approved collection	2020-12-08
202011-0920-014 Withdrawn and continue	Revision of a currently approved collection	2020-11-25
202011-0920-002 Approved without change	No material or nonsubstantive change to a currently approved collection	2020-11-04
202008-0920-014 Approved without change	No material or nonsubstantive change to a currently approved collection	2020-08-27
201910-0920-002 Approved without change	Extension without change of a currently approved collection	2019-10-16
201610-0920-010 Approved with change	New collection (Request for a new OMB Control Number)	2016-10-31

OMB Details

ASD - PRE-ENROLLMENT_Invitation Packet/Response Card (Mother)

Federal Enterprise Architecture: Health - Public Health Monitoring