# Component A: MD CADDRE: Study to Explore Early Development, SEED Phase III

> **NIH ALLCDC U01** · JOHNS HOPKINS UNIVERSITY · 2020 · $1,020,377

## Abstract

Autism Spectrum Disorder (ASD) is a severe, life-long neurodevelopmental disorder that is associated with
considerable impairment for individuals and a substantial burden to their families and communities. Little is
known about the causes or correlates of ASD. While diagnostic practices are improving ASD identification,
much remains to be discovered about risk and protective factors for ASD and about the phenotypic variation
and prevalence of co-morbid conditions. In response to growing concerns, the Children’s Health Act of 2000
mandated CDC to establish ASD surveillance and research programs that address the magnitude, incidence,
and causes of ASD and related developmental disabilities. The Centers for Autism and Developmental
Disabilities Research and Epidemiology (CADDREs) were established at six national sites (California,
Colorado, Georgia, Maryland, North Carolina, and Pennsylvania) to fulfill this mandate and are currently
carrying out the second phase of the Study to Explore Early Development (SEED), a population-based case-
control study. SEED addresses hypotheses including: ASD phenotypic variation, including clustering of core
symptoms, cognitive status, and presence of co-morbidities; gastrointestinal features; genetic variation and
gene-environment interaction (GxE); infection, immune function, and autoimmunity factors; and hormonal
factors and maternal reproductive characteristics. Data collection includes developmental assessments and
pre- and perinatal health and environment via interviews, medical record review, self-administered
questionnaires, and biologic samples. As of December 2015, SEED 1 & 2 had completed data collection on
4652 families - 1341 with ASD, 1722 with other developmental disorders, and 1589 controls. This proposal
seeks to carry out SEED 3, collecting another 625 children in each study group. This increased, combined
sample size will enable well-powered assessment of SEED hypotheses, particularly for phenotypic subgroups
and GxE interactions. Given the experience of SEED 1 & 2 and the infrastructure in place at each CADDRE
site, SEED 3 can be quickly implemented, creating a combined SEED sample of clinical, risk factor, and
biological specimens and data on over 6500 families. SEED would be the largest study of ASD of this kind,
making significant contributions to our understanding of the complex autism phenotype and
identifying potential risk and protective factors for ASD.

## Key facts

- **NIH application ID:** 9953923
- **Project number:** 5U01DD001214-05
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** M Daniele Fallin
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2020
- **Award amount:** $1,020,377
- **Award type:** 5
- **Project period:** 2016-07-01 → 2021-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9953923

## Citation

> US National Institutes of Health, RePORTER application 9953923, Component A: MD CADDRE: Study to Explore Early Development, SEED Phase III (5U01DD001214-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9953923. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*